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

Abstract

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. This cross-sectional study collected information on all AI-enabled medical devices that received FDA approval and were listed o