Abstract

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. 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. 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. 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.

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