OMB Individually Reported

Transpara Breast Care

High riskExact public inventory row

Description

Transpara software is intended for use as a concurrent reading aid for physicians interpreting full-field digital mammography exams (FFDM) and digital breast tomosynthesis (DBT) exams from compatible FFDM and DBT systems, to identify regions suspicious of breast cancer and assess their likelihood of malignancy.

Detailed example

The output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara.

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

Supporting mammography and digital breast tomosynthesis exams: it is designed to be used by physicians to improve interpretation of full-field digital mammography (FFMD) and digital breast tomosynthesis (DBT), improve detection and characterization of abnormalities, and enhance workflow.

Controls / human review

ATO: Not reported; PIA: Not published