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Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
Sponsor: BeamWorks Inc.
Summary
This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.
Official title: Multi-Reader Multi-Case, Cross-Over, Retrospective Study to Evaluate the Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
Key Details
Gender
FEMALE
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
797
Start Date
2025-08-30
Completion Date
2026-07-28
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
CadAI-B Dx
CadAI-B Dx is a Software as a Medical Device (SaMD) designed to assist physicians by providing Computer-Aided Detection (CADe) and Diagnosis (CADx) capabilities in breast ultrasound interpretation. The software automatically processes the image to identify suspicious regions (Lesion Detection) and provides a quantitative malignancy score (CadAI-Score) mapped to a corresponding BI-RADS Category. It also analyzes lesion size and BI-RADS lexicon descriptors.
Locations (1)
Yonsei University Severance Hospital
Seoul, South Korea