Evaluating the Clinical Generalizability of FDA-Approved AI-Enabled Medical Devices: Insights and Implications

Highlight

AI-enabled medical devices have rapidly expanded, especially in radiology and cardiovascular specialties, but only about half present clinical performance data at FDA approval.
Less than one-third of clinical studies report sex-specific or age-specific data, limiting insights on device applicability across diverse populations.
Retrospective designs dominate device validation, with prospective and randomized trials remaining rare, raising questions about robustness of evidence.
The scarcity of detailed development and performance data highlights significant gaps in assessing the clinical generalizability of these devices.

Study Background and Disease Burden