相关实验视频

Updated: Jan 11, 2026

Augmenting Large Language Models via Vector Embeddings to Improve Domain-Specific Responsiveness

Augmenting Large Language Models via Vector Embeddings to Improve Domain-Specific Responsiveness

Published on: December 6, 2024

评估FDA审查的医疗器械AI/ML模型特征的透明度

Viraj Mehta¹, Abhinav Komanduri², Rishabh Singh Bhadouriya³

¹Stanford University, Department of Computer Science, Stanford, USA, CA.

NPJ digital medicine

|November 17, 2025

概括

人工智能/ML医疗器械的透明度很低,对开发和性能的报告很差. 最近的FDA指导方针显示只有适度的改进,强调需要强制执行的标准来建立信任.

科学领域:

医疗技术医疗技术医学技术
监管科学监管科学
人工智能的人工智能

背景情况:

人工智能 (AI) 和机器学习 (ML) 在医疗设备中的集成需要透明的监管报告.
美国食品和药物管理局 (FDA) 在2021年引入了良好的机器学习实践 (GMLP) 指南,以解决这一需求.
在FDA审查的AI/ML医疗器械中,遵守GMLP原则仍然存在不确定性.

研究的目的:

评估FDA批准的支持AI/ML的医疗器械监管报告的透明度.
评估2021年GMLP指南对报告透明度的影响.
识别与模型开发和绩效指标有关的透明度缺口.

主要方法:

对1970年至2024年12月期间批准的AI/ML设备的1,012份FDA安全性和有效性摘要 (SSED) 的审查.
在17个类别中使用了一种新的AI特征透明度报告 (ACTR) 评分来量化透明度.
分析了2021年GMLP指南发布前后ACTR分数的变化.

主要成果:

平均ACTR得分低至17分之3.3,表明存在重大透明度缺陷.
在ACTR分数中观察到0.88点的适度改善,这是2021年后的指导方针.
几乎一半的设备缺乏临床研究报告,超过一半的设备遗漏了性能指标.

结论:

在支持AI/ML的医疗器械的监管报告中存在显著的透明度差距.
目前对GMLP原则的遵守不足以确保足够的透明度.
强制执行的标准对于增强信任和确保AI/ML医疗技术的安全至关重要.

更多相关视频

Objectification of Tongue Diagnosis in Traditional Medicine, Data Analysis, and Study Application

Objectification of Tongue Diagnosis in Traditional Medicine, Data Analysis, and Study Application

Published on: April 14, 2023

相关概念视频

Drug Regulation

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...

Pharmacovigilance

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

FDA Approved Drugs: Changes to Approved Drugs

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...