Volpara Imaging Software
Volpara Health Technologies LimitedVolpara Imaging Software is an AI-driven tool that processes raw digital mammography and tomosynthesis images to generate detailed breast density maps and quantitative metrics. It helps healthcare professionals assess breast composition by providing volumetric measurements and BI-RADS density categories as adjunctive information in breast cancer screening and assessment.
Intended Use
Volpara Imaging Software is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. It calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. It provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category and quality assurance metrics (dose and pressure) to aid healthcare professionals in breast composition assessment. It is not a diagnostic aid and used adjunctively when the final breast density categorization is made by an MQSA-qualified interpreting physician.
Technology
The software analyzes raw digital mammograms or tomosynthesis projections in an automated volumetric fashion to produce a density map representing fibroglandular tissue thickness at each pixel. From this, it computes volumetric measurements of fibroglandular tissue, breast volume, volumetric breast density, various thickness metrics of dense tissue, and image quality assurance metrics. Outputs include a DICOM Secondary Capture Image Scorecard and a DICOM Mammography CAD Structured Report. Operates on Windows/Linux or Microsoft Azure virtual appliance environments.
Performance
The software was verified and validated according to design control processes and FDA software guidance. Testing included unit and integrated system levels, risk analysis compliant with ISO 14971, compliance with ISO 62304 and DICOM 2016 standards, and software anomaly reporting. Verification and validation data from the predicate device were repeated to ensure integration and backward compatibility.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/27/2021
3 months - 2
FDA Approval
7/27/2021
Other devices from Volpara Health Technologies Limited
- Volpara Imaging Software2018 • 510K
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