Evaluation of TaiHao Breast Ultrasound Diagnosis Software

Evaluation of TaiHao Breast Ultrasound Diagnosis Software

The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.

Inclusion Criteria:

• B-mode breast ultrasound image
• Female, age 21 or older
• Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
• Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
• At least two orthogonal views of a lesion

Exclusion Criteria:

• Breast lesion images acquired after biopsy or surgery.
• Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
• Case demonstrating administrative or technical errors
• Multiple lesions in one 2-D ultrasound image
• Breast ultrasound images with Doppler, elastography, or other overlays present
• Case with less than 2-year follow-up and without biopsy confirmation