Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast

Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast

The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination

CadAI-B for Breast is a real-time AI diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.

Inclusion Criteria:

• Women who underwent breast US examination
• Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy
• Women who had been followed for more than 2 years after initial US examination

Exclusion Criteria:

• women who had breast implants
• women who had US images containing artifacts affecting the review of images