(28 days)
Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values along with a BI-RADS breast density 4th or 5th Edition category to aid health care professionals in the assessment of breast tissue composition. Volpara is not an interpretive or diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made by an MQSA qualified interpreting physician.
The Volpara Imaging Software ("Volpara") 1.5.6 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both raw digital mammograms and raw tomosynthesis projections (the central projections of which are just raw digital mammograms).
The assessment takes the form of generating and validating density maps wherein the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source.
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, .
- the 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 1cm² square region (or "focal ● density")
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 1.5.2 operates on a Windows 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.
The provided document is a 510(k) summary for the Volpara Imaging Software (Version 1.5.6), indicating its substantial equivalence to a previously cleared version (1.5.2). It does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, as typically presented in a clinical trial report or a performance study summary with quantified metrics against defined thresholds. The document primarily focuses on demonstrating the new version's substantial equivalence to the predicate device due to minor software and labeling enhancements.
Therefore, I cannot directly extract and provide the requested information from the given text regarding the acceptance criteria and a study proving the device meets specific acceptance criteria. The document confirms software verification and validation, risk analysis, and compliance with standards, but does not present a performance study with defined criteria and results in the format requested.
However, based on what is available in the document, I can infer and state the following, and highlight what information is missing:
Inferred Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence Claim):
The document argues for substantial equivalence to its predicate device (Volpara Imaging Software 1.5.2). This implies that the 'acceptance criteria' for the new version (1.5.6) were primarily that its performance for its stated indications of use remained comparable or identical to the predicate, particularly regarding the accurate calculation of volumetric breast density and BI-RADS categories.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Implicitly Met) |
|---|---|
| Calculation and quantification of density map. | Performed by the device. |
| Determination of volumetric breast density. | Performed by the device. |
| Provision of numerical values (volumetric breast density, fibroglandular tissue, total breast volume, etc.). | Values are provided. |
| Provision of BI-RADS breast density 4th or 5th Edition category. | Categories are provided. |
| Aid to healthcare professionals in assessment of breast tissue composition. | Remains adjunctive information. |
| Not an interpretive or diagnostic aid. | Remains non-interpretive. |
| Use as adjunctive information for MQSA qualified physician. | Remains adjunctive. |
| For 1.5.6 specific enhancements: | Validated (though exact metrics not detailed). |
| Generating BI-RADS category using focal density information. | Functionality added and validated. |
| Support for Hologic SmartCurve paddle data. | Compatibility added and validated. |
| Output of image quality metrics. | Functionality added and validated. |
Missing Information/Answers to Specific Questions based on the provided text:
- A table of acceptance criteria and the reported device performance: As explained above, the document argues for substantial equivalence, implying the enhanced features perform comparably to the predicate. No explicit table of quantified acceptance criteria (e.g., specific accuracy thresholds for density measurement) and corresponding performance metrics from a dedicated study are provided.
- Sample size used for the test set and the data provenance: Not specified in the document. The document states "complete verification and validation data testing conducted for the predicate was repeated in order to ensure integration and backwards compatibility," but it doesn't mention the size or characteristics (country of origin, retrospective/prospective) of this test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not indicated. The device is explicitly stated as "not an interpretive or diagnostic aid" and "should be used only as adjunctive information," suggesting it's not designed for direct comparative effectiveness with human readers or AI assistance in diagnostic performance, but rather for providing quantitative measurements.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "verification and validation testing" and states the device "calculates and quantifies a density map and from that determines volumetric breast density," which implies standalone performance for its quantitative tasks. However, specific standalone performance metrics or a detailed study are not presented.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
- The sample size for the training set: Not specified. (This particular submission is for software version 1.5.6, which builds on 1.5.2, so a 'training set' for this specific submission might be minimal if it's primarily a validation of enhancements, not a new algorithm development).
- How the ground truth for the training set was established: Not specified.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).