Genius AI
Description
Genius AI Detection is a computer-aided detection and diagnosis (CADe/CADx) software device. It is intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest, including soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in DBT exams from compatible DBT systems, and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam.
Detailed example
For each detected lesion, Genius AI Detection produces CAD results that include the location of the lesion, an outline of the lesion, and a confidence score for that lesion. Genius AI Detection also produces a case score for the entire tomosynthesis exam. Genius AI Detection packages all CAD findings derived from the corresponding analysis of a tomosynthesis exam into a DICOM Mammography CAD SR object and distributes it for display on DICOM compliant review workstations. The interpreting physician will have access to the CAD findings concurrently to the reading of the tomosynthesis exam. In addition, a combination of peripheral information such as number of marks and case scores may be used on the review workstation to enhance the interpreting physician’s workflow by offering a better organization of the patient worklist.
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Support mammographic image analysis.
Controls / human review
ATO: Not reported; PIA: Not published