Volpara Imaging Software
Matakina Technology LTDVolpara Imaging Software is a medical imaging application designed to analyze digital mammography and tomosynthesis images. It generates detailed breast density maps and calculates volumetric breast density, helping healthcare professionals assess breast tissue composition. The software provides numerical breast density values and BI-RADS categories as adjunctive information, supporting the diagnostic process.
Intended Use
Volpara 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, providing numerical values along with a BI-RADS breast density category to aid health care professionals in assessing breast tissue composition. It is not interpretive or diagnostic but adjunctive information used by MQSA-qualified physicians.
Technology
Volpara operates on a Windows server outside the patient environment. It constructs validated density maps where each pixel value represents the thickness of fibroglandular tissue between the pixel and x-ray source. From these maps, it computes quantitative density statistics such as fibroglandular tissue volume, breast volume, volumetric breast density percentage, BI-RADS breast density category, mean and maximum dense tissue thickness, and maximum dense tissue volume over any 1 cm² region.
Performance
Performance verification and validation included measurement accuracy against breast phantoms, comparison to 3D breast MRI data, reproducibility studies across datasets and imaging systems (GE, Hologic, Siemens) in mammography and tomosynthesis modes, and visual assessment correlation against BI-RADS categories assigned by MQSA-qualified radiologists. Clinical validation involved beta site usability and breast density distribution comparisons. All tests met acceptance criteria with no outstanding issues compromising safety or effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/25/2015
1 month - 2
FDA Approval
1/7/2016
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