Volpara is a software application intended for use with digital mammography systems. Volpara calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Volpara provides these numerical values for each image to aid radiologists in the assessment of breast tissue composition. Volpara produces adjunctive information. It is not an interpretive or diagnostic aid. Volpara is a software application which runs on Windows or Linux based computers.

Device Description

Volpara™ analyzes raw ("for processing") digital mammograms in a fully automated, volumetric fashion and produces a quantitative assessment of breast composition, namely volume of fibroglandular tissue in cubic centimeters (cm³) volume of breast tissue in cm³ and their ratio, volumetric breast density. Volpara v1.3 handles DICOM files as input. Volpara v1.3has been built and tested on Windows XP and Linux. Volpara software is a component which accepts as input digital mammography images along with associated calibration data. The software processes the image according to proprietary algorithms. It provides measures of: volume of fibroglandular tissue, volume of breast, breast density. The software does not perform image display but outputs to the console.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Volpara Imaging Software, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes several verification and validation tests, implying that acceptance criteria were met for each, but it does not explicitly list numerical acceptance criteria. Instead, it states that "All verification and validation testing was successful in that established acceptance criteria was met for all of the tests conducted."

Acceptance Criteria (Implicit)	Reported Device Performance (Implied)
Verification Bench Testing:
1. Volpara measurements compared to known values of standardized and calibrated breast phantoms.	Test successful; Volpara measurements met established acceptance criteria when compared to known values from phantoms.
2. Volpara results compared with BI-RADS scores from MQSA qualified radiologists for X-ray images.	Test successful; Volpara results showed agreement with BI-RADS scores provided by MQSA qualified radiologists, meeting acceptance criteria for this comparison.
3. Volpara estimates of fibroglandular tissue compared with 3D breast MRI data for X-ray images.	Test successful; Volpara's fibroglandular tissue estimates showed acceptable correlation or agreement with 3D breast MRI data.
4. Volpara breast density results compared with expected decrease in breast density with age in substantial datasets.	Test successful; Volpara's results aligned with the known physiological decrease in breast density with age in large datasets.
5. Volpara results for left and right breasts and CC and MLO views compared to confirm similarity.	Test successful; Volpara consistently produced similar results across different views (CC, MLO) and between left and right breasts, indicating robustness and consistency.
6. Volpara results compared for the same woman imaged on GE and Hologic systems one year apart, to confirm similarity.	Test successful; Volpara provided similar results (within acceptance criteria) for the same individual when imaged on different mammography systems (GE and Hologic) over a one-year period, demonstrating inter-system consistency over time.
Clinical Validation Testing:
1. Beta site testing to assess the ability of physicians to successfully integrate the software into existing systems and assess usability for target users.	Test successful; Physicians were able to successfully integrate and use the software in existing systems, indicating good usability and integration capabilities.
2. Beta site testing to collect minimum, average, and maximum Volpara breast densities and compare these to other existing databases.	Test successful; Volpara's breast density measurements (min, avg, max) were within acceptable ranges or demonstrated comparison with existing databases, meeting established acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text mentions "substantial datasets" for several tests (e.g., comparison with age, left/right and CC/MLO views, GE/Hologic system comparison). However, it does not provide specific numerical sample sizes for any of the test sets.
Data Provenance: The images used for Verification and Validation testing were acquired from detectors manufactured by both GE and Hologic. The country of origin of the data is not specified. The studies appear to be retrospective as they involve existing images and data (e.g., images with existing BI-RADS scores, 3D breast MRI data, and data where women were imaged one year apart).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the comparison with BI-RADS scores, ground truth was established by "a MQSA qualified radiologist." It does not specify how many radiologists were involved, only stating "a radiologist" in the singular.
No specific qualifications beyond "MQSA qualified radiologist" are provided (e.g., years of experience).

4. Adjudication Method for the Test Set

For the comparison with BI-RADS scores, it just states "a MQSA qualified radiologist" provided the score, implying no adjudication for this specific ground truth.
For other tests (e.g., phantoms, MRI, age correlation, left/right breast comparison), the "ground truth" seems to be objective measurements (phantoms, 3D MRI) or established medical knowledge (density change with age) rather than expert consensus requiring adjudication.
The text does not mention any expert adjudication methods (e.g., 2+1, 3+1) for establishing ground truth on any of the test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as performed in the provided text.
The device is stated to "aid radiologists in the assessment of breast tissue composition" and "produces adjunctive information," but the studies described focus on the device's accuracy and consistency in calculating volumetric breast density rather than its impact on human reader performance, either with or without AI assistance. Therefore, no effect size for human reader improvement is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was conducted through the "Verification Bench testing." These tests evaluated Volpara's outputs against objective measures (phantoms, 3D MRI), established clinical knowledge (density and age), and consistency checks (left/right, CC/MLO views, different systems over time). The software's output is numerical values, and these tests directly assess the algorithm's accuracy in calculating these values without a human-in-the-loop for interpretation of the device's output.

7. The Type of Ground Truth Used

The ground truth types varied depending on the specific test:

Known values from standardized and calibrated breast phantoms.
BI-RADS scores from an MQSA qualified radiologist.
3D breast MRI data (for fibroglandular tissue estimates).
Expected and known decrease in breast density with age (established medical knowledge).
Consistency across different views and breasts (internal consistency checks).

8. The Sample Size for the Training Set

The provided text does not mention any specific sample size for a training set. The descriptions focus on the testing of the software.

9. How the Ground Truth for the Training Set Was Established

Since no information about a training set or its sample size is provided, there is also no information on how its ground truth was established. The document describes verification and validation of the developed software.

Summary

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Section 5 510(k) Summary Prepared September 30, 2010

OCT - 7 2010

Sponsor:	Matakina Technology Limited
Contact Person:	Ralph Highnam
Telephone:	+64 - 4 - 385 9839
Fax:	+64 - 4 - 385 9839
Submission Date:	September 1, 2010
Device Name:	Volpara Imaging Software
Common Name:	Imaging Software
Regulatory Class:	II
Review Category:	Class II
Classification Panel:	Radiology
	System, Imaging Processing; 21 CFR 892.2050; LLZ

Classification:

A. Legally Marketed Predicate Devices

The modified software is substantially equivalent to the Quantra software cleared pursuant to K082483.

B. Device Description:

Volpara v1.3has been built and tested on Windows XP and Linux

Volpara software is a component which accepts as input digital mammography images along with associated calibration data. The software processes the image according to proprietary algorithms. It provides measures of:

volume of fibroglandular tissue .
volume of breast .
. breast density

The software does not perform image display but outputs to the console.

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C. Intended Use

D. Substantial Equivalence

The submission device is substantially equivalent to the predicate. Hologic Quantra software with regard to both intended use and technological characteristics. The dev ices have substantially equivalent indications for use and technological characteristics. Both devices are labeled as providing adjunctive information which is not an interpretive or diagnostic aid.

	Predicate DeviceQuantra K082483	Submission DeviceVolpara
Intended Use	Quantra software application intended foruse with Hologic digital mammographysystems. Quantra calculates volumetricbreast density as a ratio of fibroglandulartissue and total breast volume estimates.Quantra provides these numerical valuesfor each breast to aid radiologists in theassessment of breast tissue composition.Quantra produces adjunctive information.It is not an interpretive or diagnostic aid.Quantra is a software application whichruns on Hologic Cenova DICOM server.	Volpara is a software application intendedfor use with digital mammographysystems. Volpara calculates volumetricbreast density as a ratio of fibroglandulartissue and total breast volume estimates.Volpara provides these numerical valuesfor each image to aid radiologists in theassessment of breast tissue composition.Volpara produces adjunctive information.It is not an interpretive or diagnostic aid.Volpara is a software application whichruns on Windows or Linux-basedcomputers
Intended Users	Radiologists	Radiologists
Image Source	Digital mammography images	Digital mammography images
Compatibility	Hologic Digital Mammography System	GE and Hologic Digital MammographySystems
AnatomicalArea	Breast	Breast
Assessmentscope	Average of images for each breast	Provides results per image
Assessmenttype	Volumetric	Volumetric
Operatingenvironment	Not specified in product labeling	Windows or Linux-based computers
Image storageand reportgeneration	Yesappears to generate a DICOM structuredreport to send to PACS	Yesoutput to the console

Table 1 Substantial Equivalence Comparison Table

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Classification	90LLZ892.2050	90LLZ892.2050
Software Levelof Concern	Minor	Moderate

E. Performance Data

The Volpara software has been verified and validated according to the company's design control process. All of the documents specified in FDA's software guidance document have been submitted in the 510(k) Notification. A risk analysis compliant with ISO 14971 has been completed 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. Verification and Validation testing utilized images acquired from detectors manufactured by both GE and Hologic.

Verification Bench testing of Volpara volumetric breast density software included:

Measurements of Volpara as compared to known values of standardized and . calibrated breast phantoms
Volpara was run over x-ray images for which a BI-RADS score was available . from a MQSA qualified radiologist followed by a comparison of the two sets of data
. Volpara was run over x-ray images of breasts for which there was 3D breast MRI data with a comparison of estimates of fibroglandualar tissue
. Volpara was run over substantial datasets where we have the women's age and results compared with the expected and known decrease in breast density with age
. Volpara was run over substantial data sets and the results for left and right breasts and CC and MLO views were compared to confirm that the results were the similar for each view and each breast.
Volpara was run over substantial data sets where the same woman had been . imaged on GE and Hologic systems one year apart and the results were compared to confirm they were similar.

Clinical Validation testing of Volpara volumetric breast density software included :

Beta site testing to assess the ability of physicians to successfully integrate the . software into their existing systems as well as assess usability for target users
. Beta site testing to collect minimum, average and maximum Volpara breast densities and compare these to other existing databases

All verification and validation testing was successful in that established acceptance criteria was met for all of the tests conducted.

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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Matakina Technology Limited % Sheila W. Pickering, Ph.D. Consultant Sheila W. Pickering Consulting 2081 Longden Circle LOS ALTOS CA 94024

OCT - 7 2010

Re: K102556

Trade/Device Name: Volpara Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 1, 2010 Received: September 7, 2010

Dear Dr. Pickering:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5 00%) remarket notification. The FDA finding of substantial equivalence of your device to a legally renarketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K102556

Device Name:

Volpara Imaging Software

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

OCT - 7 2010

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office effective Examison (CDP) OTY)

(Division Sign-Off)

Division of Radiolog Office of In Vitro Dia anostic Device

510K K102556

1 1

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).