George Shih, Adam E Flanders
AJR Am J Roentgenol . 2024 May 15:1. doi: 10.2214/AJR.23.30331. Online ahead of print.
The investigation by Clark et al. [1] explored discrepancies in how vendors represent artificial intelligence or machine learning (AI/ML) capabilities of FDA-cleared products by comparing marketing materials available to potential customers versus the materials submitted to the FDA for premarket notification (510[k]) clearance for a predicate device.