OMB Individually Reported

iCAD ProFound AI

High riskExact public inventory row

Description

Detect breast malignancies. The ProFound Detection V4.0 software allows an interpreting physician to quickly identify suspicious soft tissue densities and calcifications by marking the detected areas in the tomosynthesis images.

Detailed example

The ProFound Detection V4.0 software allows an interpreting physician to quickly identify suspicious soft tissue densities and calcifications by marking the detected areas in the tomosynthesis images. When the ProFound Detection V4.0 marks are displayed by a user, the marks will appear as overlays on the tomosynthesis images. Each detected finding will also be assigned a “score” that corresponds to the ProFound Detection V4.0 algorithm’s confidence that the detected finding is a cancer (Certainty of Finding). Certainty of Finding scores are a percentage in range of 0% to 100% to indicate computer-assisted detection and diagnosis' (CAD) confidence that the finding is malignant. ProFound Detection V4.0 also assigns a score to each case (Case Score) as a percentage in range of 0% to 100% to indicate CAD’s confidence that the case has malignant findings. The higher the Certainty of Finding or Case Score, the higher the confidence that the detected finding is a cancer or that the case has malignant findings.

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

Accelerate detection of potential malignancies.

Controls / human review

ATO: Not reported; PIA: Not published