Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment

Evaluation of Carebot AI MMG Medical Device for Detection and Radiographic Assessment of Breast Lesions and Quantitative Analysis of Breast Density: A Multicentric, Multi-Reader Study

Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)

1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)

The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall).

The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively.

For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified.

Inclusion Criteria:

• The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.

Exclusion Criteria:

• The medical device cannot be used in patients with breast implants.
• The medical device cannot be used in male breast examination.
• The medical device cannot be used in patients under 18 years of age.