KNUCH CadAI-B-1(KCB-1)

Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study

The CadAI-B (Computer Aided Design Artificial Intelligence-Breast) system is a real-time AI diagnostic tool for breast ultrasound. It integrates with ultrasound devices to detect suspicious lesions, providing size, BI-RADS, and malignancy probability. After installation and user training, the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set, showing results in seconds. This study will assess CadAI-B's accuracy and reliability by comparing its findings with biopsy results.

Inclusion Criteria:

• Women aged 20 years or older
• Individuals scheduled to undergo breast ultrasound for diagnostic evaluation
• Patients whose Ground Truth can be determined through biopsy, surgery, or follow-up

Exclusion Criteria:

• Images containing artifacts that may affect the interpretation
• Presence of breast implants
• Significant breast trauma or mastitis at the time of the breast ultrasound that could cause distortion in image interpretation
• History of surgery or chemotherapy