Monitoring Methodology for an AI Tool for Breast Cancer Screening Deployed in Clinical Centers.

We propose a methodology for monitoring an artificial intelligence (AI) tool for breast cancer screening when deployed in clinical centers. An AI trained to detect suspicious regions of interest in the four views of a mammogram and to characterize their level of suspicion with a score ranging from one (low suspicion) to ten (high suspicion of malignancy) was deployed in four radiological centers across the US. Results were collected between April 2021 and December 2022, resulting in a dataset of 36,581 AI records. To assess the behavior of the AI, its score distribution in each center was compared to a reference distribution obtained in silico using the Pearson correlation coefficient (PCC) between each center AI score distribution and the reference. The estimated PCCs were 0.998 [min: 0.993, max: 0.999] for center US-1, 0.975 [min: 0.923, max: 0.986] for US-2, 0.995 [min: 0.972, max: 0.998] for US-3 and 0.994 [min: 0.962, max: 0.982] for US-4. These values show that the AI behaved as expected. Low PCC values could be used to trigger an alert, which would facilitate the detection of software malfunctions. This methodology can help create new indicators to improve monitoring of software deployed in hospitals.