Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use

The primary objective of any newly developed medical device using artificial intelligence (AI) is to ensure its safe and effective use in broader clinical practice.

To evaluate key characteristics of AI-enabled medical devices approved by the US Food and Drug Administration (FDA) that are relevant to their clinical generalizability and are reported in the public domain. Design, Setting, and Participants: This cross-sectional study collected information on all AI-enabled medical devices that received FDA approval and were listed on the FDA website as of August 31, 2024. Main Outcomes and Measures: For each AI-enabled medical device, detailed information and key characteristics relevant for the generalizability of the devices at the time of approval were summarized, specifically examining clinical evaluation aspects, such as the presence and design of clinical performance studies, availability of discriminatory performance metrics, and age- and sex-specific data.