Volpara Imaging Software

Overview

Development stage

DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

High-impact designation

Not high-impactSource: c) Not high-impact

Impact justification

Not reported

Start date

Not reported

Withheld from public reporting

Not reported

Mission

Topic area

Health and Medical

Operational functions

Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

Generates volumetric measurements of breast x-ray scans.

Expected benefits

Accelerate volumetric measurements of breast x-ray scans.

System outputs

From the density maps, various quantitative density-map based statistics are computed as follows: • Volume of Fibroglandular Tissue in cm3 • Volume of Breast in cm3 • Volumetric Breast Density (the percentage of fibroglandular tissue in breast) • Average thickness of dense tissue in cm • Maximum thickness of dense tissue in cm • Maximum volume of dense tissue above any 1 cm2 square region (and location) • Image quality assurance metrics From the volumetric breast density, a BI-RADS 4th Edition and 5th Edition breast density category can be attained by applying thresholds set by the software. The device outputs those metrics along with the density maps themselves, marked with the location of the various maxima. Volpara Imaging Software 1.5.6 operates on a Windows or Linux server that meets Volpara data input and output requirements and generally is located outside the patient environment. The device does not contact the patient, nor does it control any life-sustaining devices.

Technology

AI classification

Computer visionSource: Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

System name(s)

Not reported

Custom-developed code

No

Public source code

Not reported

Sourcing

How it was built

Purchased from vendorSource: a) Purchased from a vendor

Vendor (as reported)

Not reported

Vendors (standardized)

None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII

Not reported

Privacy Impact Assessment

Not reported

Authorization to Operate

Not reported

Demographic features

Not reported

Training and evaluation data

Not reported

Federal Data Catalog

Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Potential impacts and how they were identified

Not reported