This study evaluates a second review of ultrasound images of breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by Samsung Medical Imaging, to see if this artificial intelligence will help the Radiologist make more accurate diagnoses.

Using ultrasound images prospectively acquired, the purpose of this study entails a second review of ultrasound images with suspicious breast lesions using an interactive "deep learning" (or artificial intelligence) program developed by SamsungMedison Co.,Ltd.

The images will be reviewed by the radiologists twice: first without, and then with assistance of artificial intelligence program by SamsungMedison Co., Ltd.

BIRADS system will be used in this study.

The objectives of the study are twofold: to quantify the statistical equivalence of radiologists' opinion and AI's output (CADe), and to check BIRADS score-based diagnostic accuracy (CADx) that is gained by the Radiologists' use of this interactive tool

1. Inclusion Criteria:

   • Adult females or males recommended for ultrasound-guided breast lesion biopsy or ultrasound follow-up with at least one suspicious lesion
   • Age > 18 years
   • Able to provide informed consent

2. Exclusion Criteria:

   • Unable to read and understand English
   • Unable or unwilling to provide informed consent
   • A patient with current or previous diagnosis of breast cancer in the same quadrant
   • Unable or unwilling to undergo study procedures

3. Subject Characteristics

   1. Number of Subjects: 300 subjects from 300 separate breast lesions can be acquired. If a subject has more than 1 suspicious lesion, each may be chosen by the radiologist attending as suitable for "second review".
   2. Gender and Age of Subjects: Adult females or males aged 18 years or older who meet all of the inclusion criteria and none of the exclusion criteria will be considered for enrollment. Minors are excluded as breast cancer is very rare in this age group.
   3. Racial and Ethnic Origin: There are no enrollment exclusions based on economic status, race, or ethnicity. Based on local and United States census data, the expected ethnic distribution will be approximately 26 Hispanic (approx. 16%) and 134 non-Hispanic people. Furthermore, the expected racial distribution is expected to be approximately 126 White (approx. 79% of the whole study), 21 Black or African America (13%), 8 Asian (5%), and 5 of other categories (3%).
   4. Vulnerable Subjects: It is unlikely that any UR students or employees will be enrolled unless their primary physician refers them to UR Medicine Breast Imaging at Red Creek for breast ultrasound and a suspicious lesion is found. We do not expect any of these referrals to be from staffs who work directly with the PIs.

The study consisted of 10 readers with varying levels of training and experience providing analysis on a randomized set of 300 patients' breast ultrasound data with and without S-Detect for Breast. Two reading periods separated by at least 3-week washout, totaling 600 cases analyzed per reader. PI and her associate have knowledge about patients diagnosis and other information. So, they are exclueded in readers for "reviewing". And all breast US images are de-indentified.