Prospective assessment of breast lesions AI classification model based on ultrasound dynamic videos and ACR BI-RADS characteristics

INTRODUCTION: AI-assisted ultrasound diagnosis is considered a fast and accurate new method that can reduce the subjective and experience-dependent nature of handheld ultrasound. In order to meet clinical diagnostic needs better, we first proposed a breast lesions AI classification model based on ultrasound dynamic videos and ACR BI-RADS characteristics (hereafter, Auto BI-RADS). In this study, we prospectively verify its performance. METHODS: In this study, the model development was based on retrospective data including 480 ultrasound dynamic videos equivalent to 18122 static images of pathologically proven breast lesions from 420 patients. A total of 292 breast lesions ultrasound dynamic videos from the internal and external hospital were prospectively tested by Auto BI-RADS. The performance of Auto BI-RADS was compared with both experienced and junior radiologists using the DeLong method, Kappa test, and McNemar test. RESULTS: The Auto BI-RADS achieved an accuracy, sensitivity, and specificity of 0.87, 0.93, and 0.81, respectively. The consistency of the BI-RADS category between Auto BI-RADS and the experienced group (Kappa:0.82) was higher than that of the juniors (Kappa:0.60). The consistency rates between Auto BI-RADS and the experienced group were higher than those between Auto BI-RADS and the junior group for shape (93% vs. 80%; P = .01), orientation (90% vs. 84%; P = .02), margin (84% vs. 71%; P = .01), echo pattern (69% vs. 56%; P = .001) and posterior features (76% vs. 71%; P = .0046), While the difference of calcification was not significantly different. DISCUSSION: In this study, we aimed to prospectively verify a novel AI tool based on ultrasound dynamic videos and ACR BI-RADS characteristics. The prospective assessment suggested that the AI tool not only meets the clinical needs better but also reaches the diagnostic efficiency of experienced radiologists.