DM-Density is a software application intended for use with compatible full field digital mammography systems. DM-Density calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. DM-Density produces adjunctive information. It is not a diagnostic aid.

Device Description

DM-Density is a standalone software application that automatically analyzes "for presentation" full field digital mammograms to calculate breast tissue composition. The software processes full field digital mammograms according to proprietary algorithms and generates a Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scales. DM-Density has been validated on Hologic's Selenia Dimensions and Lorad Selenia systems. DM-Density data output is packaged for viewing on a mammography workstation or PACS as a DICOM mammography Structured Report or Secondary Capture. Output may also be transmitted to a RIS.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for DM-Density, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Metric)	Reported Device Performance
Reliability	Assessed using Pearson's Correlation Coefficient for DM-Density percent density, dense breast area, and total area measurements (Left/Right breasts, CC/MLO views).
Accuracy (Percent Density)	Validated DM-Density percent density and total area measurements. The accuracy of dense breast area measurements follows by implication.
Accuracy (Breast Density Grade)	Validated using the Kappa statistic against known Breast Density Grade assessments.
Reproducibility	Assessed with Pearson Correlation Coefficient using a dataset of subjects with two mammograms within a two-year period.
Inverse Relationship to Age	Assessed by calculating Pearson's Correlation Coefficient between DM-Density percent density measures and age at time of screening.

Note: The document does not provide specific numerical thresholds for "acceptance" (e.g., Pearson's correlation coefficient > 0.9, Kappa > 0.8). It only states that testing was performed "in accordance with Densitas' design control processes" and that "DM-Density product specifications have been met."

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

The exact sample size for each specific test (Reliability, Accuracy, Reproducibility, Inverse relationship to age) is not explicitly stated in the provided document.

Data Provenance: The data used for reproducibility testing was from "subjects who had two mammograms acquired on compatible mammography acquisition systems within a two year time period." The document doesn't specify the country of origin, but it does mention that DM-Density has been validated on Hologic's Selenia Dimensions and Lorad Selenia systems.

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

Number of Experts: "Expert radiologist visual assessments" were used for validation, but the exact number of experts is not specified.
Qualifications of Experts: They are referred to generally as "expert radiologists." No further details on their specific experience (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth from the expert radiologists is not explicitly stated. It mentions "expert radiologist visual assessments," but doesn't specify if it was a consensus, majority vote, or other method.

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

Was an MRMC study done? No, the document states, "There was no human clinical testing required to support the medical device." This indicates that no MRMC study involving human readers and AI assistance was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, the described performance testing (Reliability, Accuracy, Reproducibility, Inverse Relationship to Age) assesses the DM-Density software's performance as a standalone algorithm without human intervention.
- The "Accuracy" assessment specifically states "validating DM-Density percent density and total area measurements" and "validating the Breast Density Grade assessments to known Breast Density Grade assessments using the Kappa statistic," which are direct measures of the algorithm's performance against derived ground truth.

7. Type of Ground Truth Used

For Accuracy (Breast Density Grade): "expert radiologist visual assessments of mammography density" were used to establish "known Breast Density Grade assessments." This indicates expert consensus or individual expert assessment as ground truth for density categories.
For Accuracy (Percent Density) and Reliability: The ground truth for percent density, dense breast area, and total area measurements is implied to be a carefully measured value derived from the same images, likely through a reference method or manual segmentation, which the algorithm is then compared against. The document doesn't explicitly state the method for this specific ground truth, but it's not pathology or outcomes data.

8. Sample Size for the Training Set

The sample size for the training set is not provided in the document. The document refers to "proprietary algorithms" but does not detail their development or the data used for training.

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

The document does not provide information on how the ground truth for the training set was established. It only discusses "proprietary algorithms" and validation testing.

Summary

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February 23, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a blue square.

Densitas, Inc. % Mr. Ken Pilgrim Director - RA & QA Emergo Group, Inc. 2500 Bee Cave Road, Building 1, Suite 300 AUSTIN TX 78746

Re: K170540

Trade/Device Name: DM-Density Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 9, 2018 Received: February 13, 2018

Dear Mr. Pilgrim:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about mediation-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,

Michael D. O'Hara For

Robert 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) K170540

Device Name DM-Density

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 DENSITAS. The logo features a blue square made up of smaller squares, with the company name "DENSITAS" written in a bold, sans-serif font below it. Underneath the company name, the tagline "Driven by Data" is written in a smaller, italicized font.

densitas, inc. Traditional 510(k) Premarket Submission DM-DENSITY

Section 5 – 510(k) Summary

K170540

Submitter:	Densitas, Inc.1344 Summer Street, Suite 311.2Halifax, NS, B3H 0A8 Canada
Date Prepared:	12 Feb 2018
Contact Person:	Emergo Global Consulting, LLC2500 Bee Cave RoadBuilding 1, Suite 300Austin, TX 78746 USACell Phone: (604) 836.5020Office Phone: (512) 327.9997Contact: Ken Pilgrim, Sr. RA / QA ConsultantEmail: project.management@emergogroup.com
Submission Date:	January 16, 2017
Trade Name:	DM-Density
Common Name:	Medical Imaging Software
Classification Name:	System, Image Processing, Radiological21 CFR 892.2050LLZ
Device Classification:	Class II
Predicate Device(s):	iReveal® by iCAD, Inc. (formerly M-Vu® by VuCOMP, Inc.)K132742
Section 5	Page 1 of 6

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Image /page/4/Picture/0 description: The image shows the logo for DENSITAS. The logo features a blue square made up of smaller squares, with the word "DENSITAS" written in blue below it. Underneath the word "DENSITAS" is the tagline "Driven by Data" in a smaller, italicized font.

Description of Device:

DM-Density is a standalone software application that automatically analyzes "for presentation" full field digital mammograms to calculate breast tissue composition.

The software processes full field digital mammograms according to proprietary algorithms and generates a Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) density classification scales.

DM-Density has been validated on Hologic's Selenia Dimensions and Lorad Selenia systems.

DM-Density data output is packaged for viewing on a mammography workstation or PACS as a DICOM mammography Structured Report or Secondary Capture. Output may also be transmitted to a RIS. DM-Density reports are configured to provide the following data based on the two available breast density classification grades:

BI-RADS 4th Edition

For each breast:

Area of fibroglandular tissue (cm²)
· Area of breast (cm2)
Area-based breast density (%)

For each patient: DM-Density breast density grade and percent breast density

BI-RADS 5th Edition For each patient: DM-Density breast density grade

Alternative configuration options are available to match user preferences.

DM-Density can process approximately 600 cases per hour.

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Image /page/5/Picture/0 description: The image shows the logo for DENSITAS. The logo features a blue square made up of smaller squares, with the word "DENSITAS" written in blue below it. Underneath the word "DENSITAS" is the tagline "Driven by Data" in a smaller, italicized font.

Indications for Use Statement:

Substantial Equivalence Discussion:

DM-Density and iReveal (formerly M-Vu Breast Density) calculate breast density as a ratio of fibroglandular tissue and total breast area estimates. Both devices are not to be used as diagnostic aids, but to provide adjunctive information only. Users in both cases must be qualified medical practitioners and exercise their professional judgment when formulating diagnostic decisions and selecting appropriate treatment paths that are supported by breast density data. Both devices are DICOM-compliant and rely on DICOM imaging data from digital mammography systems (data input).

Table 5A – Comparison of Characteristics
Manufacturer	510(K) Submitter	Predicate	SignificantDifferences
	Densitas, Inc.	iCAD, Inc. (formerlyVuCOMP, Inc.)
Trade Name	DM-Density	iReveal (formerly M-VuBreast Density)
510(k) Number	N/A	K132742	N/A
Product Code	LLZ	LLZ	N/A
RegulationNumber	21 CFR Part 892.2050	21 CFR Part 892.2050	N/A
Regulation Name	System, Image Processing,Radiological	System, Image Processing,Radiological	N/A
Intended Use /Indications for Use	DM-Density is a softwareapplication intended for usewith compatible full field digitalmammography systems. DM-Density calculates percentbreast density defined as theratio of fibroglandular tissue tototal breast areaestimates. DM-Densityprovides these numerical	M-Vu Breast Density is asoftware application intendedfor use with digitalmammography systems. M-VuBreast Density calculates breastdensity as a ratio offibroglandular tissue and totalbreast area estimates. M-VuBreast Density provides thesenumerical values for each	N/A
	values for each breast as wellas a density category to aidinterpreting physicians in theassessment of breast tissuecomposition. DM-Densityproduces adjunctiveinformation. It is not adiagnostic aid.	breast as well as a densitycategory to aid radiologists inthe assessment of breast tissuecomposition. M-Vu BreastDensity produces adjunctiveinformation. It is not aninterpretive or diagnostic aid.
Patient Population	Symptomatic andasymptomatic womenundergoing mammography	Same	N/A
End Users	Interpreting Physicians	Same	N/A
Image SourceModalities	Hologic Selenia Dimensions	All digital radiography (DR)systems and computedradiography (CR) systems	N/A - Suite of imagesource modalities thatare compatible withiReveal include thesource modalitiescompatible with DM-Density.
	Hologic Lorad Selenia
Input: Image DataFormat	DICOM full field digitalmammography imager – ForPresentation; RCC, LCC, RMLO,LMLO	DICOM digital mammographyimager - For Processing; RCC,LCC, RMLO, LMLO	DM-Density = ForPresentation;iReveal = ForProcessing
Output Data	BI-RADS 4th Ed.For each breast:• Area of fibroglandulartissue (cm²)• Area of breast (cm²)• Area-based breast density(%)For each patient: DM-Densitybreast density grade andpercent breast densityBI-RADS 5th Ed.For each patient: DM-Densitybreast density grade	For each breast:• Area of fibroglandulartissue (cm²)• Area of breast (cm²)• Area-based breast density(%)For each patient:VuCOMP density grade/BIRADSbreast density	Subject deviceprovides breastdensity gradeconsistent with BI-RADS 5th Ed.;Predicate device doesnot conform to the 5thEd. scale.
MeasurementScales	4-category breast density scalefrom 4th Ed. ACR BI-RADS Atlas2003	4-category breast density scalefrom 4th Ed. ACR BI-RADS Atlas2003	Subject deviceprovides users withthe option of utilizingeither the 4th or 5thedition scales;Predicate Deviceutilizes 4th editionscale only
	4-category breast density scalefrom 5th Ed. ACR BI-RADS Atlas2013
Output Device	Mammography Workstation,PACS, and RIS	Same	N/A
Output Format	DICOM Structured Report andSecondary Capture	Same	N/A
Deployment	Standalone computer	Same	N/A
Data Throughput	600 cases per hour	60 – 120 cases per hour	N/A
Assessment scope	Results per image	Same	N/A
Assessment type	Area-based	Same	N/A
AnatomicalLocation	Breast	Same	N/A

Table 5A - Comparison of Characteristics

Section 5

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Clinical Performance Data:

There was no human clinical testing required to support the medical device.

Non-Clinical Performance Data:

Results from internal verification and validation testing performed in accordance with Densitas' design control processes confirm that DM-Density product specifications have been met. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.

Verification testing consisted of unit and integrated system level testing. A risk analysis in accordance with ISO 14971 was completed as part of the software design and development effort. Validation testing relied on expert radiologist visual assessments of mammography density, and is summarized as follows:

Section 5

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Image /page/8/Picture/0 description: The image contains the logo for DENSITAS. The logo features a blue square made up of smaller squares, resembling a pixelated or digital design. Below the square is the word "DENSITAS" in a bold, sans-serif font, also in blue. Underneath "DENSITAS" is the tagline "Driven by Data" in a smaller, italicized font, also in blue.

Reliability was assessed using the Pearson's Correlation Coefficient by comparing the DM-Density percent density, dense breast area and total area measurements for Left and Right breasts as well as for CC and MLO views.
Accuracy was assessed by validating DM-Density percent density and total area measurements. The . accuracy of DM-Density dense breast area measurements follows by implication.
. Accuracy was further assessed by validating the Breast Density Grade assessments to known Breast Density Grade assessments using the Kappa statistic.
Reproducibility was assessed with the Pearson Correlation Coefficient using a dataset from subjects . who had two mammograms acquired on compatible mammography acquisition systems within a two year time period.
• The inverse relationship between breast density and age was assessed by calculating the Pearson's Correlation Coefficient between DM-Density percent density measures and age at time of screening.

Statement of Substantial Equivalence:

DM-Density, as designed and developed by Densitas Inc., is determined to be substantially equivalent to the predicate device. Differences between the two devices do not raise new questions about the safety and effectiveness of DM-Density.

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).