Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices

Key Points Question Are medical devices that are marketed as enabled for artificial intelligence (AI) or machine learning (ML) being appropriately approved for AI or ML capabilities in their US Food and Drug Administration (FDA) 510(k) clearance? Findings In this systematic review of 119 public 510(k) application summaries and corresponding marketing materials, devices with significant software components similar to devices flagged in the FDA’s published list of AI- or ML-enabled devices were defined and taxonomized into categories of adherent, contentious, and discrepant devices. Of 119 devices queried, 12.6% were considered discrepant, 6.7% were considered contentious, and 80.6% were consistent between marketing and FDA 510(k) clearance summaries. Meaning These findings suggest that there were discrepancies between the marketing and 510(k) clearance of AI- or ML-enabled medical devices, with some devices marketed as having such capabilities not approved by the FDA for use of AI or ML.