Delphinus SoftVue™ ROC Reader Study
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader
 performance when SoftVue™ automated breast ultrasound and screening mammography are combined,
 compared to screening mammography alone, in women with dense breast parenchyma.

 This reader study will include approximately 32 radiologist readers and a sample of
 approximately 200 breast screening cases to be selected from the library of images collected
 under Delphinus Protocol #DMT-2015.001 (NCT03257839) Arm 1 Phases B, C, and D. The reader
 study image case set will be enriched with cancer cases.
Radiologists of any age, sex, race, ethnicity, or institutional affiliation may participate
 as study readers. All readers must meet the following base Inclusion Criteria:

 -  Hold a current United States medical license

 -  Be American Board of Radiology Certified

 -  Be MQSA-qualified

 -  Be experienced in reading DM images on a monitor

 -  Be experienced in reading Breast Ultrasound images on a monitor

 -  Have completed a Financial Disclosure showing no Conflicts of Interest

 -  Have provided a current curriculum vitae (CV)

 -  Have provided a signed Readers' Agreement

 -  Have provided written Informed Consent

 All qualified and confirmed readers will complete a multi-module SoftVue™ training program
 prior to their participation in a reading session for this study.