Imagio Feasibility Multi-Reader, Multi-Case Study

Imagio Feasibility Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio Ultrasound to Guide Decision to Biopsy

Controlled, blinded, multi-reader, multi-case study

The Imagio Feasibility Reader Study-01 Study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. The Feasibility Study will be based on ITD masses from the PIONEER (NCT01943916) Pivotal study to simultaneously reflect the distributions with and without mammograms as well as site CDU BI-RADS scores within benign and malignant masses as strata. The study population will be split into 3 cohorts - Cohort 1, the 120 patient ITD Population used to run the primary/ secondary analyses. Cohort 2, 30 patients used to run exploratory analyses on false negative rate and Cohort 3, 5 patients used to run exploratory analyses on specific mass types

Inclusion Criteria:

- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status

Exclusion Criteria:

- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status