Clinical Pre-Market, Observational, Prospective, Blinded, Controlled, Single-Center Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women

This clinical investigation is a study designed to assess the safety, diagnostic performance, and usability of Kenko Breast AI+, a medical device software intended to support breast cancer diagnosis using breast MRI.

The study is includes adult women who undergo breast MRI as part of routine clinical care for suspected breast cancer or oncological surveillance. The study does not alter standard clinical management and does not introduce additional diagnostic or therapeutic procedures.

Independent radiologist readers assess MRI examinations either with or without assistance from Kenko Breast AI+. Each MRI case is evaluated once per reader during the first assessment phase and reassessed after a washout period using the alternate method. The sequence of assessments and reader allocation is randomized. Reader assessments are compared with a reference diagnosis established according to routine clinical practice.

MRI datasets acquired during routine care are reviewed for technical quality, pseudonymized at the study site, and uploaded to both the investigational software platform and the site's picture archiving and communication system (PACS). Readers access the assigned cases through the appropriate platform according to randomization. After study completion, readers complete usability evaluations of the investigational device.

The study is conducted in accordance with ISO 14155:2020, Good Clinical Practice, and applicable regulatory requirements (EU Medical Device Regulation 2017/745). Quality assurance measures include site qualification and initiation, staff training, predefined workflows, and documented delegation of responsibilities.