M-Vu Breast Density is a software application intended for use with digital mammography systems. M-Vu Breast Density calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. M-Vu Breast Density provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. M-Vu Breast Density produces adjunctive information. It is not an interpretive or diagnostic aid.

Device Description

M-Vu Breast Density automatically analyzes "for processing" digital mammograms and calculates the dense tissue area of each breast. The measured dense tissue area is then used to provide a Calibrated Density Category which maps the percentage of breast density to a BI-RADS category number (1 - 4).

M-Vu Breast Density is a stand-alone software application designed to interoperate with all digital radiography (DR) and computed radiography (CR) mammography systems. M-Vu Breast Density is displayed in the form of a DICOM mammography structured report or secondary capture and reports the following for output:

Breast Area (cm2) for cach breast .
Dense Area (cm2) for each breast .
Percent Breast Density for each breast .
. Breast Density Category for each case

The results of M-Vu Breast Density are designed to display on a mammography workstation, high resolution monitor. or in a printed case report. M-Vu Breast Density is designed to process approximately 60-120 cases per hour.

M-Vu Breast Density Version 1.0.0.0 has been built and tested on the M-Vu CAD Station system (K061160).

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the M-Vu Breast Density device, based on the provided FDA 510(k) summary:

M-Vu® Breast Density - Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list acceptance criteria as quantitative targets for the device's performance. Instead, it describes verification and validation activities designed to demonstrate the device's functionality and alignment with known biological phenomena. The "reported device performance" is thus interpreted as the successful completion of these validation tests.

Acceptance Criteria (Implied from Validation)	Reported Device Performance (Successful Validation)
Agreement with Expert Radiologist BI-RADS Scores:	A weighted Kappa statistic was used to compare M-Vu Breast Density's calibrated density categories with BI-RADS scores obtained from 13 expert radiologists. The study implies satisfactory agreement, as it states the comparison was performed, and the overall conclusion is that the device is "safe and effective" and "substantially equivalent." However, no specific threshold for Kappa or actual Kappa value is provided.
Accuracy of Fibroglandular Tissue Estimates:	M-Vu percent breast density (PBD) and breast area measurements were verified. The verification of fibroglandular area measurement was confirmed "by implication." No specific metrics or thresholds for accuracy are provided.
Correlation with Age-Related Density Decrease:	The device's results were compared with the expected and known decrease in breast density with age using the Spearman Rank Correlation test. This implies a significant negative correlation was observed. No specific correlation coefficient or p-value is provided.
Consistency between Left and Right Breast Density:	Percent Breast Density measurements from the left and right breasts of the same patient were compared using Pearson's Correlation Coefficient. This implies a high positive correlation was observed. No specific correlation coefficient or p-value is provided.
Consistency of PBD over Time (Up to 2 years):	Percent Breast Density measurements were made on patient images and corresponding prior images (maximum two years apart) and compared using Pearson's Correlation Coefficient. This implies a high positive correlation was observed, indicating stability of measurements over time. No specific correlation coefficient or p-value is provided.
Successful Clinical Network Integration:	M-Vu CAD Station (on which M-Vu Breast Density is deployed) was successfully tested for clinical network integration. This is a functional and technical acceptance, not a performance metric for density assessment.

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

Sample Size for Expert BI-RADS Comparison: Not explicitly stated. The document mentions "a set of x-ray images for which a BI-RADS scores were obtained from 13 expert radiologists," but the number of cases or images in this set is not provided.
Sample Size for Age Correlation: Not explicitly stated. The document mentions "a data set where the women's age and results were compared," but the number of cases is not provided.
Sample Size for Left/Right Breast Comparison: Not explicitly stated.
Sample Size for Prior Image Comparison: Not explicitly stated.
Data Provenance: Not specified. It is likely retrospective, given the nature of image analysis and comparison with existing data (e.g., prior images, expert BI-RADS scores). The country of origin of the data is not mentioned.

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

Number of Experts: 13 expert radiologists were used to provide BI-RADS scores.
Qualifications of Experts: Stated as "expert radiologists." No specific details on their years of experience or subspecialty are provided.

4. Adjudication Method for the Test Set

For the primary comparison (BI-RADS scores), the document states that expert BI-RADS scores were "obtained from 13 expert radiologists." It does not specify an adjudication method (e.g., 2+1, 3+1, none) to establish a consensus ground truth from these 13 experts. It's possible each expert's score was treated individually, or a simple majority/median was used, but this detail is missing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The document explicitly states: "This submission contains no information from clinical studies." The studies conducted are validation studies for the algorithm's performance against established measures or trends, not studies comparing human reader performance with and without AI assistance.
Effect size of human reader improvement: Not applicable, as no MRMC study was performed.

6. Standalone Performance Study

Was a standalone study done? Yes. All described "non-clinical performance data" are standalone studies of the M-Vu Breast Density algorithm. The device "was run over a set of x-ray images" and its outputs were then compared to various metrics (expert BI-RADS, age trends, intra-patient consistency). This demonstrates the algorithm's performance without human intervention in the density calculation process.

7. Type of Ground Truth Used

The ground truth used for the validation studies includes:

Expert Consensus/Opinion: BI-RADS scores obtained from 13 expert radiologists.
Known Biological/Clinical Trends: The expected decrease in breast density with age.
Internal Consistency: Comparison of left vs. right breast density and density over time for the same patient.

No pathology or outcomes data were used as ground truth.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the M-Vu Breast Density algorithm.

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

The document does not provide any information on how the ground truth for the training set was established. Given the lack of training set details, this information is entirely absent.

Summary

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K132742
page 1 of 4

5 510(k) Summary

Prepared December 2, 2013

Submitter:	VuCOMP, Inc.2500 Dallas ParkwaySuite 500Plano, TX 75093
Contact Person:	Adrienne HammondCompliance ManagerPhone: (888) 266-7462Fax: (877) 577-5658
Submission Date:	August 30, 2013	DEC 03 2013
Trade Name:	M-Vu® Breast Density
Common Name:	Medical Imaging Software
Classification Name:	System, Image Processing, Radiological;21 CFR 892.2050; LLZ
Device Classification:	Class II
Predicate Device(s):	Quantra, by Hologic Inc., K082483Volpara, Matakina Technology Limited, K102556

Description of Device:

Breast Area (cm2) for cach breast .
Dense Area (cm2) for each breast .
Percent Breast Density for each breast .
. Breast Density Category for each case

M-Vu Breast Density Version 1.0.0.0 has been built and tested on the M-Vu CAD Station system (K061160).

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Intended Use Statement:

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Features andCharacteristics	Predicate Devices
	VuCOMPM-Vu Breast Density	HologicQuantraK082483	Matakina TechnologyVolparaK102556
Patient Population	Symptomatic and asymptomatic women undergoing mammography
End Users	Radiologists
Image Source Modalities	All digital radiography (DR) systemsand computed radiography (CR) systems	Hologic 2D, GE 2D, and SiemensMammiomat Novation digitalradiography (DR) systems only	All digital radiography (DR) systems and computed radiography (CR)systems
Input: Image Data Format	DICOM digital mammography image	For processing: Views processed: RCC, LCC, RMLO, LMLO
Output Format	DICOM structured report and secondary capture
Output Data	For each breast:• Area of fibroglandular tissue (cm²)• Area of breast (cm²)• Area-based breast density (%)For each patient:VuCOMP density grade/BIRADSbreast density	For each image, breast, and patient:• Volume of fibroglandular tissue (cm³)• Volume of breast (cm³)• Volumetric breast density (%)• Volume of fibroglandular score• Volume of breast density score• BIRADS-like breast density integerscore and fractional score	For each breast:• Volume of fibroglandular tissue (cm³)• Volume of breast (cm³)• Volumetric breast density (%)For each patient:Volpara density grade/BIRADS breast density
Output Device	Mammography Workstation, PACS, and RIS
Deployment	Stand-alone computer
Data Throughput	60-120 cases per hour	30-60 cases per hour	45-60 cases per hour

Summary of Technological Characteristics:

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K132742
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Summary of Clinical Performance Data:

This submission contains no information from clinical studies.

Summary of Non-Clinical Performance Data:

M-Vu Breast Density has been verified and validated according to VuCOMP's design control processes. All supporting documentation has been included in this 510(k) Premarket Notification. Verification activity included unit, integration, and system level testing. Validation included the following:

. M-Vu Breast Density was run over a set of x-ray images for which a BI-RADS scores were obtained from 13 expert radiologists followed by a comparison of the data sets using a weighted Kappa statistic
. Estimates of fibroglandular tissue were confirmed by verifying the M-Vu percent breast density (PBD) and the M-Vu breast area. The verification of fibroglandular area measurement follows by implication.
. M-Vu Breast Density was run over a data set where the women's age and results were compared with the expected and known decrease in breast density with age using the Spearman Rank Correlation test.
. Percent Breast Density measurements from the left and right breasts of the same patient were compared to confirm that the results were similar using Pearson's Correlation Coefficient.
Percent Breast Density measurements were made on patient images and . corresponding prior images with a maximum imaging period of two years apart and the results were compared to confirm that they were similar using Pearson's Correlation Coefficient.
M-Vu Breast Density is deployed on the M-Vu CAD Station. M-Vu CAD Station . was successfully tested for clinical network integration.

Conclusion:

Based upon the information presented in this submission, it is concluded that M-Vu Breast Density is safe and effective for the intended use, and is substantially equivalent to the named predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G604 Silver Spring, MD 20993-0002

December 3. 2013

VuCOMP, Inc. % Richard Morroney, RAC, CQA Director of Quality and Regulatory Affairs 2500 Dallas Parkway, Suite 500 PLANO TX 75093

Re: K132742

Trade/Device Name: M-Vu" Breast Density Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 1J.Z. Dated: October 30, 2013 Received: October 31, 2013

Dear Mr. Morroney:

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. Insting 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 (IPMA). 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 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 (2) CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2-Mr. Morroney

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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4 Indication(s) for Use Statement

510(k) Number (if known): K132742 Device Name: M-Vu Breast Density Indications for Use:

Prescription Use X (Part 21 CFR 80) Subpart D)

AND/OR

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

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

Smir to) Concurrence of Center for Devices and Radiological Health (CDRH) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K132742

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).