This study aims to evaluate Effectiveness of Investigational Device, Lunit INSIGHT MMG, in the assistance of Detection and Diagnosis of Breast Cancer during Screening Mammography Interpretation.
The Lunit INSIGHT MMG is developed as a computer-assisted detection/diagnosis device based on deep learning technology. In this pivotal study, effectiveness of the investigational device, Lunit INSIGHT MMG, was examined by comparing the reading panelist's interpretation ability between CAD assisted and unassisted during screening mammography interpretation.
Study Type
OBSERVATIONAL
Enrollment
240
FFDM (Full-Field Digital mammography)
Atrius Health
Boston, Massachusetts, United States
Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve
Patient-level FBR (forced BI-RADS) area under the Receiver Operating Characteristic (ROC) curve to measure the effectiveness of Investigational Device between CAD assited and unassisted environment
Time frame: Through study completion, an average of 6 months
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