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

Launched by CAREBOT S.R.O. · May 20, 2024

Keywords

ClinConnect Summary

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, ...

Gender

FEMALE

Eligibility criteria

• 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.