PMA Required Pivotal Multi-reader Multi-case Reader Study

This study will be conducted according to US and international standards of Good Clinical Practice (FDA regulations 21 CFR 11, 50, 56, and 812 and FDA guidance E6). Applicable government regulations and Medical University of South Carolina research policies and procedures will also be followed. The goal of the study is to evaluate if 3D KBCT can improve the clinical performance of diagnostic workup for breast cancer detection and diagnosis compared to 2D Diagnostic Mammography. This study will involve 18 readers reading and scoring the conventional 2D diagnostic mammograms and the 3D KBCT images of 236 cases. Each reader will undergo one day of training prior to beginning the reader study. The reader study will be broken up into one three-day reading session (includes training day) and three two-day reading sessions with a washout period of at least four weeks in between sessions. The 2D diagnostic mammograms include standard 2-view mammograms and any additional diagnostic views. The ROC curves will be constructed for 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO) (screening or diagnostic), and 3D KBCT. The area under the ROC curve (AUC) will be compared. The clinical decision regarding biopsy will also be evaluated by estimating the sensitivity and specificity of 2D Diagnostic Mammography, 3D KBCT plus Standard 2-view Mammography (CC and MLO), and 3D KBCT. This study, including the training of the participating radiologists, will be conducted at the Department of Radiology at Medical University of South Carolina.