Densitas densityai™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ produces adjunctive information. It is not a diagnostic aid.

Device Description

Densitas densityai™ is a standalone software application that automatically analyzes "for presentation" data from digital breast x-ray systems, including digital breast tomosynthesis exams, to assess breast tissue composition. The software processes the data 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) 5th edition density classification scale. Densitas densityai™ 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. Densitas densityai™ reports are configured to provide the following data based on the BI-RADS 5th edition breast density classification grade: For each patient: DENSITAS breast density grade (BDG).

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the densitas densityai™ device, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., minimum accuracy percentages). Instead, it presents the device's performance metrics, implying that these results were deemed acceptable for substantial equivalence. The performance is assessed by comparing the device's breast density classifications against expert radiologist consensus.

Table of Performance for densitas densityai™ (all scan types)

Category Type	Performance Metric	Value
4x4 Confusion Matrix (A,B,C,D Categories)
Overall Kappa	Kappa statistic (agreement with radiologist consensus)	0.87 (95% CI: 0.87, 0.87)
Accuracy (Category A)	Device accuracy for Category A (Fatty)	78% (72 correct out of 92 total A classifications by radiologists)
Accuracy (Category B)	Device accuracy for Category B	76% (225 correct out of 295 total B classifications by radiologists)
Accuracy (Category C)	Device accuracy for Category C	83% (262 correct out of 319 total C classifications by radiologists)
Accuracy (Category D)	Device accuracy for Category D (Extremely Dense)	89% (84 correct out of 94 total D classifications by radiologists)
Grouped Confusion Matrix (Fatty A/B vs. Dense C/D)
Overall Kappa	Kappa statistic (agreement with radiologist consensus)	0.84 (95% CI: 0.8, 0.88)
Accuracy (Fatty A/B)	Device accuracy for Fatty (A,B) categories	88% (340 correct out of 387 total Fatty classifications by radiologists)
Accuracy (Dense C/D)	Device accuracy for Dense (C,D) categories	96% (393 correct out of 409 total Dense classifications by radiologists)

Additionally, other performance aspects were assessed through internal testing:

Reliability: Measured by Pearson's Correlation Coefficient for percent density, dense breast area, and total area measurements between left and right breasts.
Accuracy: Validated for percent density and total area measurements.
Reproducibility: Measured by Pearson's Correlation Coefficient by running the algorithm twice over the same images.
Inverse Relationship with Age: Pearson's Correlation Coefficient between percent density and age.

2. Sample Size and Data Provenance

Test Set Sample Size: n=796 cases
Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. The description says "a large dataset that spanned all compatible scanner types," which implies diversity, but specifics are missing.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Four expert radiologists.
Qualifications: "Expert radiologists" is stated, but no specific experience (e.g., years of experience, subspecialty certification) is detailed in the provided document.

4. Adjudication Method

The ground truth was established by a "consensus assessment of four expert radiologists' independent readings." This implies an adjudication method where their individual readings were combined to form a single reference standard, but the specific consensus rule (e.g., majority vote, specific tie-breaking) is not described.

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

No MRMC comparative effectiveness study was explicitly mentioned. The study focused on the standalone performance of the AI device compared to expert consensus, not on how human readers' performance improved with AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done. The results presented in the tables (Kappa, Accuracy) directly assess the algorithm's performance in categorizing breast density against the expert radiologist consensus without human intervention.

7. Type of Ground Truth Used

Expert Consensus: The ground truth for the validation study was established through "a consensus assessment of four expert radiologists' independent readings of overall breast composition." This falls under expert consensus.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only describes the validation testing.

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

The document does not provide details on how the ground truth for the training set was established. Since the training set size isn't mentioned, neither are the methods for its ground truth. The information provided focuses solely on the validation/test set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym and name on the right. The seal on the left is a circular emblem with an eagle in the center, surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 19, 2020

Densitas, Inc. % Alex Morris Director, Programs & Regulatory Affairs #66, 1344 Summer Street Halifax, NS B3H 0A8 CANADA

Re: K192973

Trade/Device Name: densitas densityai™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 13, 2020 Received: February 18, 2020

Dear Alex Morris:

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/cfpmn/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 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

{1}------------------------------------------------

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K192973

Device Name densitas densityai™

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Densitas. The logo consists of a yellow honeycomb pattern on the left and the word "densitas" in lowercase letters on the right. The honeycomb pattern is made up of many small yellow circles arranged in a hexagonal grid.

Section 5 - Special 510(k) Summary

K192973

Submitter:	Densitas, Inc.#66, 1344 Summer StreetHalifax, NS, B3H 0A8 Canada
Date Prepared:	06-Feb-2020
Contact Person:	Contact: Alex Morris, Dir., Programs and Regulatory AffairsDirect: 647-470-4363Office: 902-405-4610Email: alex@densitas.health
Submission Date:	21-Oct-2019
Trade Name:	densitas densityai™ (formerly DM-Density™) 2.5.0
Common Name:	Medical Imaging Software
Classification Name:	System, Image Processing, Radiological21 CFR 892.2050LLZ
Device Classification:	Class II
Predicate Device(s):	DM-Density™ 2.1.0b K170540
	No reference devices were used in this submission

Description of Device:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for "densitas". To the left of the word is a yellow hexagon made up of many small yellow circles. The word "densitas" is in a simple, sans-serif font and is black.

The software processes the data 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) 5th edition density classification scale.

Densitas densityai™ 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. Densitas densityai™ reports are configured to provide the following data based on the BI-RADS 5th edition breast density classification grade:

BI-RADS 5th Edition

For each patient: DENSITAS breast density grade (BDG)

Alternative configuration options are available to match user preferences. Densitas densityai™ can process approximately 600 cases per hour.

Indications for Use Statement:

Densitas densityal™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ produces adjunctive information. It is not a diagnostic aid.

Comparison with Predicate device:

The focus of this submission is to introduce compatibility with new digital breast x-ray systems, including digital breast tomosynthesis.

Manufacturer	510(K) Submitter	Predicate	Significant Differences	Intended Use /Indications for Use	Densitas densityai™ is asoftware application intendedfor use with compatible fullfield digital mammography anddigital breast tomosynthesissystems. Densitas densityai™provides an ACR BI-RADS Atlas5th Edition breast densitycategory to aid interpretingphysicians in the assessment ofbreast tissue composition.Densitas densityai™ producesadjunctive information. It is nota diagnostic aid.	DM-Density is a softwareapplication intended for usewith compatible full field digitalmammographysystems. DM-Density calculatespercent breast density definedas the ratio of fibroglandulartissue to totalbreast area estimates.DM-Density provides thesenumerical values for eachbreast as well as a densitycategory to aid interpretingphysicians in the assessment ofbreast tissue composition.DM-Density producesadjunctive information. It is nota diagnostic aid.	Addition of breasttomosynthesissystems
	Densitas, Inc.	Densitas, Inc.		Patient Population	Symptomatic andasymptomatic womenundergoing mammography	Symptomatic andasymptomatic womenundergoing mammography	N/A
Trade Name	densitas densityai™(formerly DM-Density™)	DM-Density™		End Users	Interpreting Physicians	Interpreting Physicians	N/A
510(k) Number	K192973	K170540	N/A	Image SourceModalities	FFDMHologic Selenia DimensionsHologic Lorad SeleniaGE Senographe EssentialGE Senographe PristinaSiemens MAMMOMATInspirationSiemens MAMMOMATNovation DRSiemens MAMMOMAT FusionSiemens MAMMOMATInspiration PrimeSiemens MAMMOMATRevelationSynthetic 2DHologic C-View	Hologic Selenia DimensionsHologic Lorad Selenia	Addition of new FFDMscan types andsynthetic 2dcompatibility
Product Code	LLZ	LLZ	N/A	Input: Image DataFormat	DICOM digital mammographyimager - For Presentation;RCC, LCC, RMLO, LMLO	DICOM full field digitalmammography imager – ForPresentation; RCC, LCC, RMLO,LMLO	similar
Regulation Number	21 CFR Part 892.2050	21 CFR Part 892.2050	N/A	Output Data	BI-RADS 5th Ed.	BI-RADS 4th Ed.For each breast:• Area of fibroglandular tissue(cm2)	Removed BI-RADS 4thedition compatibility
Regulation Name	System, Image Processing, Radiological	System, Image Processing, Radiological	N/A

Table 1 – Comparison of Characteristics

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the word "densitas" in a simple, sans-serif font. To the left of the word is a geometric design made up of yellow circles. The circles are arranged in a pattern that resembles a cube or a three-dimensional grid, with the circles gradually decreasing in size towards the bottom.

{6}------------------------------------------------

DENSITAS, INC. Special 510(k) Premarket Submission densitas densityai™

Image /page/6/Picture/1 description: The image shows the logo for "densitas". To the left of the word is a yellow hexagon made up of many small yellow circles. The word "densitas" is in a simple, sans-serif font and is black.

	For each patient: densitasdensityai™ breast densitygrade	• 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
MeasurementScales	4-category breast density scalefrom 5th Ed. ACR BI-RADS Atlas2013	4-category breast density scalefrom 4th Ed. ACR BI-RADS Atlas20034-category breast density scalefrom 5th Ed. ACR BI-RADS Atlas2013	Removed BI-RADS 4thedition compatibility
Output Device	Mammography Workstation,PACS, and RIS	Mammography Workstation,PACS, and RIS	N/A
Output Format	DICOM Structured Report andSecondary Capture	DICOM Structured Report andSecondary Capture	N/A
Deployment	Standalone computer	Standalone computer	N/A
Data Throughput	600 cases per hour	600 cases per hour	N/A
Assessment scope	Results per image	Results per image	N/A
Assessment type	Image feature-based	Area-based	Adjusted to reflectshift to imagefeature-basedassessment type
AnatomicalLocation	Breast	Breast	N/A

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 densityai™ product specifications have been met. Supporting documentation is included in this Special 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

{7}------------------------------------------------

DENSITAS, INC. Special 510(k) Premarket Submission densitas densityai™

Image /page/7/Picture/1 description: The image shows the logo for "densitas". On the left side of the logo is a yellow hexagon made up of yellow dots. The dots are more dense in the center of the hexagon and less dense on the edges. To the right of the hexagon is the word "densitas" in black lowercase letters.

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:

Reliability was assessed using the Pearson's Correlation Coefficient by comparing the densitas densityai™ percent density, dense breast area and total area measurements for Left and Right breasts.
· Accuracy was assessed by validating densityai™ percent density and total area measurements. The accuracy of densityai™ 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 by running the algorithm twice over the same set of images.
The inverse relationship between breast density and age was assessed by calculating the Pearson's Correlation Coefficient between densitas densityai™ percent density measures and age at time of screening for data sets where age was known.

Densitas results were compared to a consensus assessment of four expert radiologists' independent readings of overall breast composition on a large dataset that spanned all compatible scanner types. Results for individual (Table 2) and grouped categories (Table 3) are summarized below.

Table 2 - 4 X 4 confusion matrix for the density software and the reference standard using the
BI-RADS 5th edition breast density scale (A,B,C,D) (all scan types)

n=796; Kappa 0.87 (0.87, 0.87)
		the density software
		A	B	C	D	Accuracy
RadiologistConsensus	A	72	20	0	0	78%
	B	23	225	47	0	76%
	C	0	16	262	37	83%
	D	0	0	10	84	89%
	Total	95	261	319	121

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for "densitas". On the left side of the logo is a yellow cube made up of many small yellow circles. To the right of the cube is the word "densitas" in a simple, sans-serif font. The word is in black.

Table 3 - Confusion matrix for the density software and the reference standard using the BL-RADS 5th edition breast density scale grouped into Fatty (A,B) and Dense (C,D) density categories (all scan types)

n=796; Kappa 0.84 (0.8, 0.88)
		the density software		Accuracy
		Fatty (A,B)	Dense (C,D)
ConsensusRadiologist	Fatty (A,B)	340	47	88%
	Dense (C,D)	16	393	96%
	Total	356	440

Statement of Substantial Equivalence:

Densitas densityai™(formerly DM-Density) 2.5.0, is determined to be substantially equivalent to the predicate device, DM-Density 2.1.0b. Differences between the two devices do not raise new questions about the safety or effectiveness of the software.

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).