Performance evaluation methods for improvements at post-market of artificial intelligence/machine learning-based computer-aided detection/diagnosis/triage in the United States

Computer-aided detection (CADe), computer-aided diagnosis (CADx), and computer-aided simple triage (CAST), which incorporate artificial intelligence (AI) and machine learning (ML), are continually undergoing post-market improvement. Therefore, understanding the evaluation and approval process of improved products is important. This study intended to conduct a comprehensive survey of AI/ML-based CAD products approved by the U.S. Food and Drug Administration (FDA) that had been improved post-market to gain insights into the efficacy and safety required for market approval. A survey of the product code database published by the FDA identified eight products that were improved post-market. The methods used to evaluate the performance of improvements were analysed, and post-market improvements were approved with retrospective data. Reader study testing (RT) or software standalone testing (SA) procedures were conducted retrospectively. Six RT procedures were conducted because of modifications to the intended use. An average of 17.3 readers (minimum 14, maximum 24) participated, and the area under the curve (AUC) was considered the primary endpoint. The addition of study learning data that did not change the intended use and changes in the analysis algorithm were evaluated by SA. The average sensitivity, specificity, and AUC were 93% (minimum 91.1, maximum 97), 89.6% (minimum 85.9, maximum 96), and 0.96 (minimum 0.96, maximum 0.97), respectively. The average interval between applications was 348 days (minimum –18, maximum 975), which showed that the improvements were implemented within approximately one year. This is the first comprehensive study on AI/ML-based CAD products that have been improved post-market to elucidate evaluation points for post-market improvements. The findings will be informative for the industry and academia in developing and improving AI/ML-based CAD.