AI/ML

AI / ML
  • 文章类型: Journal Article
    耐药菌的出现对现代医学提出了重大挑战。作为回应,人工智能(AI)和机器学习(ML)算法已成为对抗抗菌素耐药性(AMR)的强大工具。这篇综述旨在探讨AI/ML在AMR管理中的作用,专注于识别病原体,理解抵抗模式,预测治疗结果,发现新的抗生素。AI/ML的最新进展使大型数据集的高效分析成为可能,以最少的人为干预促进AMR趋势和治疗反应的可靠预测。ML算法可以分析基因组数据,以识别与抗生素抗性相关的遗传标记,能够制定有针对性的治疗策略。此外,AI/ML技术在优化药物管理和开发传统抗生素替代品方面显示出希望。通过分析患者数据和临床结果,这些技术可以帮助医疗保健提供者诊断感染,评估其严重性,并选择合适的抗菌疗法。虽然AI/ML在临床环境中的整合仍处于起步阶段,数据质量和算法开发的进步表明,即将广泛的临床采用。总之,AI/ML在改善AMR管理和治疗结果方面具有重要意义。
    The emergence of drug-resistant bacteria poses a significant challenge to modern medicine. In response, Artificial Intelligence (AI) and Machine Learning (ML) algorithms have emerged as powerful tools for combating antimicrobial resistance (AMR). This review aims to explore the role of AI/ML in AMR management, with a focus on identifying pathogens, understanding resistance patterns, predicting treatment outcomes, and discovering new antibiotic agents. Recent advancements in AI/ML have enabled the efficient analysis of large datasets, facilitating the reliable prediction of AMR trends and treatment responses with minimal human intervention. ML algorithms can analyze genomic data to identify genetic markers associated with antibiotic resistance, enabling the development of targeted treatment strategies. Additionally, AI/ML techniques show promise in optimizing drug administration and developing alternatives to traditional antibiotics. By analyzing patient data and clinical outcomes, these technologies can assist healthcare providers in diagnosing infections, evaluating their severity, and selecting appropriate antimicrobial therapies. While integration of AI/ML in clinical settings is still in its infancy, advancements in data quality and algorithm development suggest that widespread clinical adoption is forthcoming. In conclusion, AI/ML holds significant promise for improving AMR management and treatment outcome.
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  • 文章类型: Journal Article
    目标:体外受精(IVF)有可能为全球数百万人提供婴儿,然而,它仍然没有得到充分利用。我们建立了一个全球适用和本地适应的试管婴儿预后报告和框架,以支持患者提供者咨询,并使验证,数据驱动的治疗决策。这项研究调查了与机器学习使用相关的IVF利用率,提供者-患者治疗前和IVF咨询中的中心特定(MLCS)预后报告(Univfy®报告)。方法:我们使用了一项回顾性队列,包括2016年至2022年在美国七个州和安大略省17个地点的七个生育中心的24,238例新患者就诊(NPV)。加拿大。我们在180天内测试了Univfy报告使用情况与第一次子宫内授精(IUI)和/或第一次IVF使用情况(也称为转换)的关联,360天,和“永远”的净现值作为主要结果。结果:Univfy报告的使用与更高的直接IVF转换相关(没有先前的IUI),比值比(OR)3.13(95%CI2.83,3.46),2.89(95%CI2.63,3.17),和2.04(95%CI1.90,2.20)和总IVF转换(有或没有先前的IUI),或3.41(95%CI3.09,3.75),3.81(95%CI3.49,4.16),180天内为2.78(95%CI2.59,2.98),360天,和以往的分析,分别为p<0.05。在使用Univfy报告的患者中,在考虑中心因素后,年龄是IVF转换的一个小但独立的预测因子.结论:使用以患者为中心,基于MLCS的预后报告与新生育患者的IVF转换增加相关。有必要进行进一步研究,以研究影响治疗决策的因素,并利用MLCS报告对以患者为中心的工作流程进行实际优化。
    Objectives: In vitro fertilization (IVF) has the potential to give babies to millions more people globally, yet it continues to be underutilized. We established a globally applicable and locally adaptable IVF prognostics report and framework to support patient-provider counseling and enable validated, data-driven treatment decisions. This study investigates the IVF utilization rates associated with the usage of machine learning, center-specific (MLCS) prognostic reports (the Univfy® report) in provider-patient pre-treatment and IVF counseling. Methods: We used a retrospective cohort comprising 24,238 patients with new patient visits (NPV) from 2016 to 2022 across seven fertility centers in 17 locations in seven US states and Ontario, Canada. We tested the association of Univfy report usage and first intra-uterine insemination (IUI) and/or first IVF usage (a.k.a. conversion) within 180 days, 360 days, and \"Ever\" of NPV as primary outcomes. Results: Univfy report usage was associated with higher direct IVF conversion (without prior IUI), with odds ratios (OR) 3.13 (95% CI 2.83, 3.46), 2.89 (95% CI 2.63, 3.17), and 2.04 (95% CI 1.90, 2.20) and total IVF conversion (with or without prior IUI), OR 3.41 (95% CI 3.09, 3.75), 3.81 (95% CI 3.49, 4.16), and 2.78 (95% CI 2.59, 2.98) in 180-day, 360-day, and Ever analyses, respectively; p < 0.05. Among patients with Univfy report usage, after accounting for center as a factor, older age was a small yet independent predictor of IVF conversion. Conclusions: Usage of a patient-centric, MLCS-based prognostics report was associated with increased IVF conversion among new fertility patients. Further research to study factors influencing treatment decision making and real-world optimization of patient-centric workflows utilizing the MLCS reports is warranted.
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  • 文章类型: Journal Article
    医疗技术领域的人工智能(AI)技术有望通过改善获取途径来改变医疗保健服务。质量,和结果。随着这些技术的监管轮廓正在被定义,关于关键利益相关者的文献明显缺乏,例如在塑造监管框架方面有重要投入的组织和利益集团。本文探讨了这些利益相关者在塑造人工智能医疗技术监管范式方面的观点和贡献。人工智能监管框架的形成需要伦理的趋同,监管,技术,社会,和实际考虑。这些多种观点有助于不断发展的监管范式的各个维度。从世界卫生组织(WHO)制定的全球治理准则到国家法规,这篇文章不仅揭示了这些多重观点,还揭示了它们在塑造人工智能监管格局方面的相互联系。
    Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and outcomes. As the regulatory contours of these technologies are being defined, there is a notable lack of literature on the key stakeholders such as the organizations and interest groups that have a significant input in shaping the regulatory framework. This article explores the perspectives and contributions of these stakeholders in shaping the regulatory paradigm of AI-enabled medical technologies. The formation of an AI regulatory framework requires the convergence of ethical, regulatory, technical, societal, and practical considerations. These multiple perspectives contribute to the various dimensions of an evolving regulatory paradigm. From the global governance guidelines set by the World Health Organization (WHO) to national regulations, the article sheds light not just on these multiple perspectives but also on their interconnectedness in shaping the regulatory landscape of AI.
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  • 文章类型: Journal Article
    MASH是一种常见的肝脏疾病,可以进展为纤维化,肝硬化,肝细胞癌(HCC),最终死亡,但是没有批准的疗法。白三烯B4(LTB4)是一种有效的促炎趋化因子,可驱动巨噬细胞和中性粒细胞趋化,以及其高亲和力受体的遗传丧失或抑制,白三烯B4受体1(BLT1),结果改善胰岛素敏感性和减少肝脏脂肪变性。为了验证BLT1抑制在MASH和纤维化的炎症和促纤维化小鼠模型中的治疗效果,小鼠受到胆碱缺乏的攻击,L-氨基酸定义了高脂肪饮食,并用30或90mg/kg的BLT1拮抗剂处理8周。肝功能,组织学,在研究结束时评估基因表达。BLT1拮抗剂治疗显著降低血脂和肝脏脂肪变性,但对肝损伤生物标志物或组织学终点如炎症没有影响,气球,或纤维化与对照相比。人工智能驱动的数字病理学分析显示,用BLT1拮抗剂治疗的肝脏中脂肪变性共同定位纤维化的显着减少。肝脏RNA-seq和途径分析揭示了脂肪酸的显著变化,花生四烯酸,和类花生酸代谢途径与BLT1拮抗剂治疗,然而,这些变化不足以影响炎症和纤维化终点.在慢性肝病动物模型中使用小分子抑制剂靶向LTB4-BLT1轴应谨慎考虑,和其他研究是必要的,以了解在MASH和肝纤维化的背景下BLT1抑制的机制细微差别。
    MASH is a prevalent liver disease that can progress to fibrosis, cirrhosis, hepatocellular carcinoma (HCC), and ultimately death, but there are no approved therapies. Leukotriene B4 (LTB4) is a potent pro-inflammatory chemoattractant that drives macrophage and neutrophil chemotaxis, and genetic loss or inhibition of its high affinity receptor, leukotriene B4 receptor 1 (BLT1), results in improved insulin sensitivity and decreased hepatic steatosis. To validate the therapeutic efficacy of BLT1 inhibition in an inflammatory and pro-fibrotic mouse model of MASH and fibrosis, mice were challenged with a choline-deficient, L-amino acid defined high fat diet and treated with a BLT1 antagonist at 30 or 90 mg/kg for 8 weeks. Liver function, histology, and gene expression were evaluated at the end of the study. Treatment with the BLT1 antagonist significantly reduced plasma lipids and liver steatosis but had no impact on liver injury biomarkers or histological endpoints such as inflammation, ballooning, or fibrosis compared to control. Artificial intelligence-powered digital pathology analysis revealed a significant reduction in steatosis co-localized fibrosis in livers treated with the BLT1 antagonist. Liver RNA-seq and pathway analyses revealed significant changes in fatty acid, arachidonic acid, and eicosanoid metabolic pathways with BLT1 antagonist treatment, however, these changes were not sufficient to impact inflammation and fibrosis endpoints. Targeting this LTB4-BLT1 axis with a small molecule inhibitor in animal models of chronic liver disease should be considered with caution, and additional studies are warranted to understand the mechanistic nuances of BLT1 inhibition in the context of MASH and liver fibrosis.
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  • 文章类型: Journal Article
    发现小分子药物的过程涉及筛选众多化合物并优化最有前途的化合物,在体外和体内。然而,在试验过程中,约90%的优化候选药物因意外毒性或疗效不足而失败.关于药物-蛋白质相互作用的当前概念表明每个小分子与平均6-11个靶标相互作用。这意味着批准的药物甚至停用的化合物可以通过利用它们与非预期目标的相互作用来重新利用。因此,我们为小分子开发了一个计算再利用框架,它将基于人工智能/机器学习(AI/ML)和基于化学相似性的目标预测方法与跨物种转录组学信息相结合。这种重新利用的方法结合了八种不同的目标预测方法,包括三种机器学习方法。通过对由2766种FDA批准的针对多个治疗目标类别的药物组成的“数据集”使用多种正交方法,我们确定了涉及2013年蛋白质靶标的27,371个脱靶相互作用(即,每个药物平均约10个相互作用)。相对于数据集中的药物,我们鉴定出150,620种结构相似的化合物.预测的相互作用数量最高的是针对G蛋白偶联受体(GPCRs)的药物,酶,以及具有10,648、4081和3678相互作用的激酶,分别。值得注意的是,已经在体外确认了17,283(63%)的脱靶相互作用。对于1105个FDA批准的药物,大约4000个相互作用的IC50<100nM,对于696个FDA批准的药物,1661个相互作用的IC50<10nM。一起,对许多预测的相互作用的确认以及对人类和动物组织中组织特异性表达模式的探索,为潜在的药物重新用于新的治疗应用提供了见解。
    The process of discovering small molecule drugs involves screening numerous compounds and optimizing the most promising ones, both in vitro and in vivo. However, approximately 90% of these optimized candidates fail during trials due to unexpected toxicity or insufficient efficacy. Current concepts with respect to drug-protein interactions suggest that each small molecule interacts with an average of 6-11 targets. This implies that approved drugs and even discontinued compounds could be repurposed by leveraging their interactions with unintended targets. Therefore, we developed a computational repurposing framework for small molecules, which combines artificial intelligence/machine learning (AI/ML)-based and chemical similarity-based target prediction methods with cross-species transcriptomics information. This repurposing methodology incorporates eight distinct target prediction methods, including three machine learning methods. By using multiple orthogonal methods for a \"dataset\" composed of 2766 FDA-approved drugs targeting multiple therapeutic target classes, we identified 27,371 off-target interactions involving 2013 protein targets (i.e., an average of around 10 interactions per drug). Relative to the drugs in the dataset, we identified 150,620 structurally similar compounds. The highest number of predicted interactions were for drugs targeting G protein-coupled receptors (GPCRs), enzymes, and kinases with 10,648, 4081, and 3678 interactions, respectively. Notably, 17,283 (63%) of the off-target interactions have been confirmed in vitro. Approximately 4000 interactions had an IC50 of <100 nM for 1105 FDA-approved drugs and 1661 interactions had an IC50 of <10 nM for 696 FDA-approved drugs. Together, the confirmation of numerous predicted interactions and the exploration of tissue-specific expression patterns in human and animal tissues offer insights into potential drug repurposing for new therapeutic applications.
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  • 文章类型: Journal Article
    人们越来越担心人类暴露于纳米粒子(NPs)的可能风险。一些研究已经报道了在不同条件下NPs在多孔介质中的传输行为。因此,在预测模型中可以使用这些信息,以便可以预测任何未探索的NP的运输行为。他研究的主要重点,因此,是应用不同的基于机器学习(ML)的模型来预测各种NP的传输效率并识别重要特征。为了实现目标,首先,通过从选定的NP的已发表论文中提取数据来准备数据集[即,银(nAg),二氧化钛(nTiO2),氧化锌(nZnO),氧化石墨烯(nGO),等。].然后,随机森林,XGBoost,和CatBoost算法结合合成少数过采样技术(SMOTE)被应用,其中保留分数(RF)被视为目标特征和粒子特征(即,表面电荷,尺寸,concentration),溶液化学[pH,离子强度(IS),多孔介质特性(晶粒尺寸,孔隙率)和流速被认为是训练特征。研究结果表明,CatBoost联合SMOTE在预测整个NP范围(R2>0.89和MSE<0.007)以及单个NP的RF方面表现最好。特征重要性分析表明四个特征,即zeta电位,IS,pH值,和粒径(NPs的整个范围,nGO,nZnO)或晶粒尺寸(nAg,nTiO2)具有显著的权重(>75%)。结果表明,这些特征超过了运输行为的预测,而不是单个NP的类型。特征的相对重要性取决于所使用的参数的范围。确定的重要特征与基础物理过程一致,这使得预测模型更加可靠。
    There is a rising concern related to the possible risk of human exposure to nanoparticles (NPs). Several studies have reported on the transport behavior of NPs in the porous media under varying conditions. Thus, there is a scope to use this information in a predictive model so that the transport behavior of any un-explored NPs could be predicted. The main focus of his study, therefore, is to apply different machine learning (ML) based models to predict the transport efficiency of a wide range of NPs and to identify the important features. To achieve the objective, first, the dataset is prepared by extracting data from published papers for selected NPs [i.e., silver (nAg), titanium dioxide (nTiO2), zinc oxide (nZnO), graphene oxide (nGO), and etc.]. Then, random forest, XGBoost, and CatBoost algorithms combined with synthetic minority oversampling technique (SMOTE) were applied where retention fraction (RF) is considered as the target feature and particle characteristics (i.e., surface charge, size, concentration), solution chemistry [pH, ionic strength (IS]), porous media properties (grain size, porosity) and flow rate are considered as the training features. The outcome of the study indicates that CatBoost combined with SMOTE performed the best in predicting RF for the entire range of NPs (R2 > 0.89 and MSE < 0.007) as well as for individual NPs. Feature importance analysis indicates four features, namely zeta potential, IS, pH, and particle diameter (the entire range of NPs, nGO, nZnO) or grain size (nAg, nTiO2) have significant weightage (>75%). The result suggests that the features overrule the prediction of transport behavior rather than the types of individual NPs. The relative importance of the features depends on the range of the parameter used. The identified important features are in accordance with the underlying physical process, which makes the prediction model more reliable.
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  • 文章类型: Journal Article
    背景:世界上第二常见的癌症和女性中最常见的恶性肿瘤是乳腺癌。在印度,乳腺癌是一个重要的健康问题,死亡率与发病率之比高,并且在年轻时出现。
    结果:最近的研究发现,肠道菌群是一个影响肠道发育的重要因素,治疗,和乳腺癌的预后。这篇综述文章旨在描述微生物菌群失调对乳腺癌发生的影响以及肿瘤基因组与特定乳腺癌分子亚型之间可能的相互作用。该综述还进一步讨论了表观遗传学和饮食/营养在肠道和乳腺微生物组调节中的作用及其与乳腺癌预防的关系。治疗,和复发。此外,微生物组研究的最新技术进步,包括下一代测序(NGS)技术,基因组测序,单细胞测序,和微生物代谢组学以及人工智能(AI)的最新进展也进行了综述。这是试图呈现作为关键癌症生物标志物的微生物组的全面状态。
    结论:我们认为将微生物群系与癌变相关联是重要的,因为它可以提供对微生物菌群失调影响癌症发展和进展的机制的见解。导致微生物组作为预测和个性化治疗工具的潜在用途。
    The second most frequent cancer in the world and the most common malignancy in women is breast cancer. Breast cancer is a significant health concern in India with a high mortality-to-incidence ratio and presentation at a younger age.
    Recent studies have identified gut microbiota as a significant factor that can have an influence on the development, treatment, and prognosis of breast cancer. This review article aims to describe the influence of microbial dysbiosis on breast cancer occurrence and the possible interactions between oncobiome and specific breast cancer molecular subtypes. The review further also discusses the role of epigenetics and diet/nutrition in the regulation of the gut and breast microbiome and its association with breast cancer prevention, therapy, and recurrence. Additionally, the recent technological advances in microbiome research, including next-generation sequencing (NGS) technologies, genome sequencing, single-cell sequencing, and microbial metabolomics along with recent advances in artificial intelligence (AI) have also been reviewed. This is an attempt to present a comprehensive status of the microbiome as a key cancer biomarker.
    We believe that correlating microbiome and carcinogenesis is important as it can provide insights into the mechanisms by which microbial dysbiosis can influence cancer development and progression, leading to the potential use of the microbiome as a tool for prognostication and personalized therapy.
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  • 文章类型: Journal Article
    在现代药物发现中,化学信息学和定量构效关系(QSAR)模型的结合已经成为一个强大的联盟,使研究人员能够利用机器学习(ML)技术的巨大潜力进行预测性分子设计和分析。这篇综述深入探讨了化学信息学的基本方面,阐明化学数据的复杂性和分子描述符在揭示潜在分子特性中的关键作用。分子描述符,包括2D指纹和拓扑索引,结合结构-活动关系(SAR),是开启小分子药物发现途径的关键。开发稳健的ML-QSAR模型的技术复杂性,包括特征选择,模型验证,和绩效评估,在此讨论。各种ML算法,如回归分析和支持向量机,在文本中展示了它们预测和理解分子结构与生物活性之间关系的能力。这篇综述为研究人员提供了全面的指导,提供对化学信息学之间协同作用的理解,QSAR,ML。由于拥抱这些尖端技术,预测性分子分析有望加快药物科学中新型治疗剂的发现。
    In modern drug discovery, the combination of chemoinformatics and quantitative structure-activity relationship (QSAR) modeling has emerged as a formidable alliance, enabling researchers to harness the vast potential of machine learning (ML) techniques for predictive molecular design and analysis. This review delves into the fundamental aspects of chemoinformatics, elucidating the intricate nature of chemical data and the crucial role of molecular descriptors in unveiling the underlying molecular properties. Molecular descriptors, including 2D fingerprints and topological indices, in conjunction with the structure-activity relationships (SARs), are pivotal in unlocking the pathway to small-molecule drug discovery. Technical intricacies of developing robust ML-QSAR models, including feature selection, model validation, and performance evaluation, are discussed herewith. Various ML algorithms, such as regression analysis and support vector machines, are showcased in the text for their ability to predict and comprehend the relationships between molecular structures and biological activities. This review serves as a comprehensive guide for researchers, providing an understanding of the synergy between chemoinformatics, QSAR, and ML. Due to embracing these cutting-edge technologies, predictive molecular analysis holds promise for expediting the discovery of novel therapeutic agents in the pharmaceutical sciences.
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  • 文章类型: Journal Article
    数学建模,概率估计,统计推断代表了用于数据驱动预测的现代人工智能(AI)方法的核心要素,预测,分类,风险估计,和预后。目前有许多工具可以帮助计算和可视化单变量概率分布,然而,很少有资源冒险进入多元分布,它们通常用于高级统计推断和人工智能决策。本文介绍了一种新的网络计算器,可以对二元和三元概率分布进行一些计算和可视化。
    探索了几种计算双变量和三变量联合概率密度的方法,包括使用高斯copula的最优多变量建模。我们开发了一个交互式网络应用程序,以直观地说明数学公式之间的相似之处,计算实现,以及多元概率密度和累积分布函数的图形描述。为了确保接口和功能独立于硬件平台,可扩展,和功能,应用程序及其组件小部件使用HTML5和JavaScript实现。
    我们通过在不同实验条件下测试多变量copula模型并检查估计的多变量概率密度和分布函数值的准确性和可靠性方面的性能来验证webapp。
    本文演示了建筑,实施,并利用多元概率计算器。建议的webapp实现可在线免费获得(https://socr。umich.edu/HTML5/BivariateNormal/BVN2/),可用于协助各种数据科学家的教育和研究,STEM讲师,和AI学习者。
    UNASSIGNED: Mathematical modeling, probability estimation, and statistical inference represent core elements of modern artificial intelligence (AI) approaches for data-driven prediction, forecasting, classification, risk-estimation, and prognosis. Currently there are many tools that help calculate and visualize univariate probability distributions, however, very few resources venture beyond into multivariate distributions, which are commonly used in advanced statistical inference and AI decision-making. This article presents a new web-calculator that enables some calculation and visualization of bivariate and trivariate probability distributions.
    UNASSIGNED: Several methods are explored to compute the joint bivariate and trivariate probability densities, including the optimal multivariate modeling using Gaussian copula. We developed an interactive webapp to visually illustrate the parallels between the mathematical formulation, computational implementation, and graphical depiction of multivariate probability density and cumulative distribution functions. To ensure the interface and functionality are hardware platform independent, scalable, and functional, the app and its component widgets are implemented using HTML5 and JavaScript.
    UNASSIGNED: We validated the webapp by testing the multivariate copula models under different experimental conditions and inspecting the performance in terms of accuracy and reliability of the estimated multivariate probability densities and distribution function values.
    UNASSIGNED: This article demonstrates the construction, implementation, and utilization of multivariate probability calculators. The proposed webapp implementation is freely available online (https://socr.umich.edu/HTML5/BivariateNormal/BVN2/) and can be used to assist with education and research of a diverse array of data scientists, STEM instructors, and AI learners.
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  • 文章类型: Journal Article
    向开发人员介绍医疗设备监管流程和人工智能和机器学习(AI/ML)设备提交中的数据注意事项,并讨论与AI/ML相关的监管挑战和活动。
    AI/ML技术正在越来越多的医疗成像设备中使用,这些技术的快速发展带来了新的监管挑战。我们向AI/ML开发人员介绍了美国食品和药物管理局(FDA)的监管概念,进程,和广泛的医学成像AI/ML设备类型的基本评估。
    AI/ML设备的设备类型和适当的上市前监管途径基于与设备相关的风险水平,并根据其技术特征和预期用途提供信息。AI/ML设备提交包含广泛的信息和测试,以促进具有模型描述的审查过程,数据,非临床试验,和多阅读器多案例测试是许多AI/ML设备提交的AI/ML设备审查过程的关键方面。该机构还参与与AI/ML相关的活动,以支持指导文件的开发,良好的机器学习实践开发,AI/ML透明度,AI/ML监管研究,和真实世界的绩效评估。
    FDA的AI/ML监管和科学努力支持确保患者在整个设备生命周期内获得安全有效的AI/ML设备并刺激医疗AI/ML创新的共同目标。
    UNASSIGNED: To introduce developers to medical device regulatory processes and data considerations in artificial intelligence and machine learning (AI/ML) device submissions and to discuss ongoing AI/ML-related regulatory challenges and activities.
    UNASSIGNED: AI/ML technologies are being used in an increasing number of medical imaging devices, and the fast evolution of these technologies presents novel regulatory challenges. We provide AI/ML developers with an introduction to U.S. Food and Drug Administration (FDA) regulatory concepts, processes, and fundamental assessments for a wide range of medical imaging AI/ML device types.
    UNASSIGNED: The device type for an AI/ML device and appropriate premarket regulatory pathway is based on the level of risk associated with the device and informed by both its technological characteristics and intended use. AI/ML device submissions contain a wide array of information and testing to facilitate the review process with the model description, data, nonclinical testing, and multi-reader multi-case testing being critical aspects of the AI/ML device review process for many AI/ML device submissions. The agency is also involved in AI/ML-related activities that support guidance document development, good machine learning practice development, AI/ML transparency, AI/ML regulatory research, and real-world performance assessment.
    UNASSIGNED: FDA\'s AI/ML regulatory and scientific efforts support the joint goals of ensuring patients have access to safe and effective AI/ML devices over the entire device lifecycle and stimulating medical AI/ML innovation.
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