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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 21, 2018

Volpara Health Technologies Limited Ralph Highnam CEO Level 7, 44 Victoria Street, Wellington Central WELLINGTON, 6011 NEW ZEALAND

Re: K182310

Trade/Device Name: Volpara Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 3, 2018 Received: August 24, 2018

Dear Ralph Highnam:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hse 2. Nils

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182310

Device Name Volpara Imaging Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Volpara Health Technologies. The word "volpara" is written in a bold, sans-serif font in blue. Below the word "volpara" is the phrase "health technologies" in a smaller, sans-serif font, also in blue. To the right of the word "volpara" is a stylized graphic of three blue shapes that resemble leaves or petals.

Special 510(k) Summary Prepared 15th August 2018

Sponsor: Volpara Health Technologies
Company Address: Level 7, 44 Victoria Street, Wellington, 6011, New Zealand
Contact Person: Ralph Highnam
Telephone: +64 - 4 - 499 - 6029
+64 4 499 6029 Fax:
ralph.highnam@volparasolutions.com Email:
Submission Date: 15th August 2018
510(k) submission number: K182310
Device Name: Volpara Imaging Software
Common Name: Imaging Software

Classification:

Requlatory Class: = Review Category: Class II Classification Panel: Radiology System, Imaging Processing; 21 CFR 892.2050; LLZ

Legally Marketed Predicate Devices:

The modified software, Volpara Imaging Software ("Volpara") 1.5.6 is substantially equivalent to the original Volpara Imaging Software 1.5.2 cleared pursuant to K153427 (Volpara Health Technologies Limited), which serves as the primary predicate.

Predicate Device Description:

The Volpara Imaging Software ("Volpara") 1.5.2 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both raw digital

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Image /page/4/Picture/0 description: The image shows the logo for Volpara Health Technologies. The word "volpara" is written in a bold, sans-serif font in a dark blue color. Below the word "volpara" is the phrase "health technologies" in a smaller, lighter font. To the right of the word "volpara" are three stylized shapes in a light blue color, resembling a bird in flight.

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.

Comparison with Predicate Device:

Volpara Imaging Software 1.5.6 is the same core software as the predicated device Volpara Imaging Software 1.5.2 with the addition of the following software and labeling enhancements.

. The modified software uses the focal density information when generating a Bl-RADS breast density category.
The modified software supports data acquired using Hologic's SmartCurve paddle. ●
. The modified software provides output image quality metrics which were validated but not output by 1.5.2.
. The User Manual has been expanded to cover the modifications described above, and with an updated bibliography.
The software provides an option to select highlighting of density scores at a specified threshold.

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Image /page/5/Picture/0 description: The image shows the logo for Volpara Health Technologies. The logo features the word "volpara" in a bold, blue sans-serif font. Above the right side of the word is a stylized graphic of three blue teardrop shapes. Below the word "volpara" are the words "health technologies" in a smaller, sans-serif font.

Substantial Equivalence Comparison Table

	Predicate DeviceVolpara 1.5.2 (K153427)	Submission Device,Volpara 1.5.6
Intended Use	VolparaDensity is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. VolparaDensity 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. VolparaDensity 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.	Same as predicate.
Intended Users	Health Care Professionals.	Health Care Professionals.
Image Source	Digital mammography images.	Digital mammography images.
Image Sources	Digital mammograms from mammography or tomosynthesis systems.	Digital mammograms from mammography or tomosynthesis systems, including those obtained using with curved paddles.
Anatomical Area	Breast	Breast
Assessment Scope	Volumetric	Volumetric
Operating Environment	Windows	Windows
Image Storage and Report Generation	Yes	Yes
	Output to the console.	Output to the console.
Numeric Output	Volume of Fibroglandular tissueVolume of BreastVolumetric Breast DensityBIRADS 4th or 5th Edition Breast Density CategoryAverage thickness of dense tissueMaximum thickness of dense tissue (and location).	Volume of Fibroglandular tissueVolume of BreastVolumetric Breast DensityBIRADS 4th or 5th Edition Breast Density Category, with highlighting above a certain volumetric threshold or if focal density presentAverage thickness of dense tissue
	Maximum volume of dense tissueabove any 1cm² square region(and location).	Maximum thickness of densetissue (and location).Maximum volume of dense tissueabove any 1cm² square region(and location).Image quality assessment metrics
Image Output	Density map in DICOM SCI format,for visualization as user specifies.	Density map in DICOM SCI format,for visualization as user specifies
Classification	21 CFR 892.2050; LLZ	21 CFR 892.2050; LLZ
Software Level of Concern	Moderate	Moderate

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Intended Use:

VolparaDensity is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. VolparaDensity 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. VolparaDensity 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.

Device Description

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")

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Image /page/7/Picture/0 description: This image shows the Volpara health technologies logo on the left side of the image. On the right side of the image, the document type is listed as a report. The DMS number is Mtk3252-007-1, the revision date is August 3, 2018, and the DMS reference is Eng/Ultron. The title of the document is Volpara Imaging Software 510(k) Summary, and it is page 5 of 5.

image quality assessment 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, with an increase in density category if a focal density appears to be present.

The device outputs those metrics along with the density maps themselves marked with the location of the various maxima.

Volpara 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.

Performance Data

The Volpara software has been verified and validated according to the company's design control process. All of the documents specified in the FDA's various software quidance documents have been submitted in this Special 510(k) Notification. An ISO 14971 compliant risk analysis has been provided and incorporated into the development effort. Software testing included both unit level and integrated system level testing. A report of outstanding anomalies was included in the software information.

The modified device was tested and determined to be compliant to the following standards: ISO 14971:2012 Medical devices – Application of risk management to medical devices: ISO 62304-2006 Software Life Cycle Processes, DICOM 2015.

In addition to the verification and validation testing conducted for the specific modification to the software detailed in this Special 510(k) submission, complete verification and validation data testing conducted for the predicate was repeated in order to ensure integration and backwards compatibility.

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing.

Conclusion:

The Special 510(k) Premarket Notification for VolparaDensity 1.5.6 contains adequate information and data to demonstrate substantial equivalence to the predicate device.

Regulation Number and Section

§ 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).