The effectiveness of ultrasonography (USG) in liver cancer screening is partly constrained by the operator’s expertise. We aimed to develop and evaluate an AI-assisted system for detecting and classifying focal liver lesions (FLLs) from USG images. This retrospective study incorporated 26,288 USG images from 5444 patients to train YOLOv5 model for FLLs detection and classification of seven different types of FLLs, including hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), focal fatty infiltration, focal fatty sparing (FFS), cyst, hemangioma, and regenerative nodules. AI model performance was assessed for detection and diagnosis of the FLLs on a per-image and per-lesion basis. The AI achieved an overall FLLs detection rate of 84.8% (95%CI:83.3–86.4), with consistent performance for FLLs ≤ 1 cm and > 1 cm. It also exhibited sensitivity and specificity for distinguishing malignant FLLs from other benign FLLs at 97.0% (95%CI:95. 9–98.2) and 97.0% (95%CI:95.9–98.1), respectively. Among specific FLL types, CCA detection rate was at 92.2% (95%CI:88.0–96.4), followed by FFS at 89.7% (95%CI:87.1–92.3), and HCC at 82.3% (95%CI:77.1–87.5). The specificities and NPVs for regenerative nodules were 100% and 99.9% (95%CI:99.8–100.0), respectively. Our AI model can potentially assist physicians in FLLs detection and diagnosis during USG examinations. Further external validation is needed for clinical application.
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