DenSeeMammo is a software application intended for use with digital mammography systems. DenSeeMammo estimates BI-RADS breast density value by analyzing processed digital 2D mammograms using a fully automated comparison procedure.

DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density.

DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician.

DenSeeMammo core software has been built and tested on OS X based computers.

DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers.

DenSeeMammo is compatible for images obtained from GE Senographe Essentials systems.

Device Description

DenSeeMammo analyzes processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density value.

DenSeeMammo handles processed images extracted from DICOM files as input.

DenSeeMammo core software has been built and tested on OS X based computers.

DenSeeMammo graphical user interface software has been built and tested on Windows, OS X and Linux based computers.

DenSeeMammo software is a component which accepts digital mammography images as an input. The software processes and analyses the image according to proprietary algorithms which allow comparison to qualified databases containing images previously quoted by radiologists.

For each patient it provides measures of BI-RADS breast density category. DenSeeMammo provides results per patient based on the maximum density category of the two breasts. The patient population is symptomatic and asymptomatic women undergoing mammography. The software does perform illustrative image display but only for illustrative purposes and not for interpretation or diagnostic.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for DenSeeMammo v1.0, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "established acceptance criteria was met for all of the tests conducted." However, it does not provide specific quantitative acceptance criteria values or detailed performance metrics for DenSeeMammo v1.0. It only describes the types of tests performed.

Test Type	Acceptance Criteria (Not Explicitly Stated Quantitatively)	Reported Device Performance (Not Explicitly Stated Quantitatively)
Reproducibility (over same data sets)	Consistency of results	Successful (Criteria met)
Reproducibility (left/right breast density comparison)	Consistency of results	Successful (Criteria met)
Comparison to visual assessment by MQSA radiologists	Agreement with expert ratings	Successful (Criteria met)
Run over substantial data sets (previously assessed)	Agreement with expert ratings on a larger scale	Successful (Criteria met)
Beta site testing (integration & usability)	Successful integration into existing systems and usability for target users	Successful (Criteria met)

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

Sample Size for Test Set: The document mentions "a data sets of images" and "a sample of exams" for reproducibility tests, and "substantial data sets of images" for comparison with expert assessments. However, specific numerical sample sizes are not provided for any of these test sets.
Data Provenance: Not explicitly stated (e.g., country of origin). The document indicates the data used were "previously visually assessed by MOSA radiologists," implying real-world mammograms. It does not clarify if the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The document consistently refers to "MQSA radiologists" or "MOSA radiologists" (likely a typo for MQSA), implying multiple qualified experts.
Qualifications of Experts: "MQSA qualified interpreting physician" or "MQSA radiologists." MQSA (Mammography Quality Standards Act) qualified indicates they are certified for mammography interpretation in the US. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set:

Not explicitly stated. The document only mentions that DenSeeMammo results were "compared to visual assessment from MQSA radiologists" and run on data "previously visually assessed by MOSA radiologists." It does not describe how discrepancies among multiple radiologists (if present) were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study demonstrating how human readers improve with AI vs. without AI assistance was not reported. The study focused on the performance of the DenSeeMammo software itself compared to expert assessment. The device is explicitly stated as "adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician."

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

Yes, the verification bench testing and the clinical validation testing appear to describe standalone performance evaluations. DenSeeMammo was "run over twice on a data sets of images to test reproducibility" and "was run over substantial data sets of images." The core function is "fully automated comparison procedure." The results from the device were then compared to expert assessment, suggesting the algorithm's standalone output was the subject of evaluation.

7. The Type of Ground Truth Used:

The ground truth used was expert consensus/visual assessment by MQSA qualified radiologists. The device's results were compared to "qualified databases containing images previously quoted by radiologists" and "visual assessment from MQSA radiologists."

8. The Sample Size for the Training Set:

The sample size for the training set is not mentioned in the provided document. The document refers to "qualified databases" that the algorithm uses for comparison, but it does not specify the size or details of these databases or how they relate to the development/training of the software.

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

The document states that the software "analyses the image according to proprietary algorithms which allow comparison to qualified databases containing images previously quoted by radiologists." This implies that the ground truth for these "qualified databases" was established by radiologists' assessments. However, further details on the process of establishing this ground truth for the training data (e.g., number of radiologists, adjudication, specific criteria) are not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 5, 2016

STATLIFE % Mrs. Robyn Bonnett Authorized Correspondent EPIDEMIO3D 50 Milk Street, 16th Floor BOSTON MA 02109

Re: K152009

Trade/Device Name: DENSEEMAMMO v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 20, 2016 Received: October 24, 2016

Dear Mrs. Bonnett:

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. 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 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.

Michael O'Hara

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

For

Enclosure

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Indications for Use

510(k) Number (if known) K152009

Device Name DENSEEMAMMO v1.0

Indications for Use (Describe)

DenSeeMammo provides a Bl-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density.

DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician. DenSeeMammo core software has been built and tested on OS X based computers.

DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers.

DenSeeMammo is compatible for images obtained from GE Senographe Essentials systems.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

1 Submitter Information

Company Name:	STATLIFE
Company Address:	39 RUE CAMILLE DESMOULINS94800 VILLEJUIF FRANCE
Company Phone:	+33 660 848 385
Company Facsimile:	+33 185 091 475
Contact Person:	Stéphane Ragusa, CEO
Authorized CorrespondentPhone	Valérie Hélin, Director of medical and regulatory affairs+33 682 437 010

2 Trade name and Common name

Trade Name:	DenSeeMammo
Software Version:	1.0
Common Name:	Imaging Software

3 Device Classification

Regulatory Class:	II
Classification Panel:	Radiology;
Product Code:	LLZ
Classification:	System, Image Processing, Radiological: 21 CFR § 892.2050

Identification of Predicate Device 4

The predicate device used for DenSeeMammo software is the following device: K102556 (October 7, 2010) – VOLPARA Imaging Software (MATAKINA Technology Limited)

5 Device Description

DenSeeMammo analyzes processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density value.

DenSeeMammo handles processed images extracted from DICOM files as input.

DenSeeMammo core software has been built and tested on OS X based computers.

DenSeeMammo graphical user interface software has been built and tested on Windows, OS X and Linux based computers.

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6 Indications for Use

DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density.

DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician.

DenSeeMammo core software has been built and tested on OS X based computers.

DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers.

DenSeeMammo is compatible for images obtained from GE Senographe Essentials systems.

7 Technological Characteristics

DenSeeMammo is a software that aims at assessing the breast density of a woman. The software use processed digital 2D mammograms in a fully automated comparison procedure that produces a BI-RADS breast density value. The software processes and analyses the image according to proprietary algorithms which allow comparison to qualified databases containing images previously quoted by radiologists. For each patient it provides measures of BI-RADS breast density category. DenSeeMammo provides results per patient based on the maximum density category of the two breasts.

The software works in a client-server mode and requires that the user computer is on the same local network as the server. Computations are made on the server part of the system that also provide the graphical user interface to display the results. A web browser is required to display the graphical user interface: to select the patients' images and to display the assessment of the breast density according to the BI-RADS standards and the similar images.

The software was developed using the Java-1.8 language as a 3-component web application (See 11.1 Components). The software was developed following an adapted version of the model - view controller software architectural pattern.

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The device does not contact the patient, nor does it control any life-sustaining devices.

Substantial Equivalence 8

The comparison of the proposed device with the predicate device warrants a determination of substantial equivalence when considered in combination with the test results and technical information provided in this 510(k) Premarket Notification. Both devices are labeled as providing adjunctive information which is not an interpretive or diagnostic aid.

Table 1 Substantial Equivalence comparison table

Characteristics	DENSEEMAMMO v1	VOLPARA ™ Imaging SoftwareK102556
Classification	LLZ892.2050	LLZ892.2050
Software level of concern	Moderate	Moderate
Device type	Not an interpretive or diagnostic aid.	Not an interpretive or diagnostic aid.
Intended Use	DenSeeMammo is a software application intended for use with digital mammography systems.DenSeeMammo estimates BI-RADS breast density value by analyzing processed digital 2D mammograms using a fully automated comparison procedure.DenSeeMammo provides a BI-RADS breast density 5th Edition category to aid radiologists in the assessment of breast density.DenSeeMammo produces adjunctive information. It is not an interpretive or diagnostic aid when the final assessment of breast density category is made by an MQSA qualified interpreting physician.DenSeeMammo core software has been built and tested on OS X based computers. DenSeeMammo graphical use interface software has been built and tested on Windows, OS X and Linux based computers.	Volpara is a software application intended for use with digital mammography systems. Volpara calculates 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.
Intended users	Radiologists	Radiologists
Patient population	Symptomatic and asymptomatic women undergoing mammography	Symptomatic and asymptomatic women undergoing mammography
Image source	Digital mammography images	Digital mammography images
Compatibility	GE Digital Mammography systems	GE and Hologic Digital Mammography systems

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Characteristics	DENSEEMAMMO v1	VOLPARA TM Imaging SoftwareK102556
Anatomical area	Breast	Breast
Assessment scope	Provides results per patient based onthe maximum density category of thetwo breasts	Provides results per image (per eachbreast)
Assessment type	Comparison to qualified databasescontaining images previously quoted byMQSA radiologists using ACR BI-RADS Vrecommendations	Volumetric
Measures provided	For each breast: BI-RADS V breastdensity categoryFor each patient: BI-RADS V breastdensity value	For each breast:→ Volume of fibro glandular tissue→ Volume of breast→ Breast densityFor each patient:VOLPARA density grade/BIRADS breastdensity
Operating environment	Software core: OS X based computersSoftware graphical user interface:Windows, OS X or Linux basedcomputers	Windows or Linux-based computers
Deployment	Stand-alone computer	Stand-alone computer

9 Performance Testing

The DenSeeMammo software has been verified and validated according to the company's design control process and particularly according the IEC 62304 standard. A risk analysis compliant with ISO 14971 has been provided. Software testing included both unit level and integrated system level testing.

Verification bench testing of DenSeeMammo breast density software included:

DenSeeMammo was run over twice on a data sets of images to test reproducibility.
DenSeeMammo was run over on a sample of exams and left and right breast densities were compared to test reproducibility.
DenSeeMammo results were compared to visual assessment from MQSA radiologists.
DenSeeMammo was run over substantial data sets of images, which had been previously visually assessed by MOSA radiologists.

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Clinical validation testing of DenSeeMammo 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.

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

10 General Safety and Effectiveness Concerns

The device 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.

11 Conclusions Drawn from Studies

The results demonstrate that the DenSeeMammo device is substantially equivalent to the predicate device in function and indications for use.

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).