The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.

Device Description

Quantra is a software application used to produce assessments of breast composition and categorize them. A breast consists of fat and fibroglandular tissue. Fibroglandular tissue, also referred to as dense tissue, contains a mixture of fibrous connective tissue (stroma) and glandular tissue (epithelial cells), and usually appears brighter than surrounding tissue on a digital mammographic image. Abnormal lesions also appear bright on a mammogram and can be obscured or masked by fibroglandular tissue.

The Quantra software is designed to estimate breast composition categories by analyzing distribution and texture of parenchymal tissue patterns which can be responsible for the masking effect during mammographic reading.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state formal acceptance criteria with specific thresholds for performance metrics. Instead, it presents performance results from a study, effectively demonstrating the device's capabilities. The "Acceptance Criteria" here are inferred from the demonstrated performance in categorizing breast density.

Performance Metric (Inferred Acceptance Criteria)	Reported Device Performance (Quantra 2.2 2D)	Reported Device Performance (Quantra 2.2 Tomo)
Accuracy for "Fatty" (a+b) category	92.9%	92.0%
Accuracy for "Dense" (c+d) category	99.1%	94.0%
Overall cases tested	230	230

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

Sample Size: 230 studies.
Data Provenance: Retrospectively collected images of 4-view screening negative cases. The country of origin is not specified in the provided text.

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

Number of Experts: 5 radiologists.
Qualifications of Experts: Not explicitly stated, beyond being "radiologists". It's implied they are qualified to assess BI-RADS® 5th Edition categories.

4. Adjudication Method for the Test Set

Adjudication Method: "5 radiologists' consensus assessment of BI-RADS 5th Edition categories" was used to establish the ground truth. This implies a consensus method, but the specific rule (e.g., simple majority, all 5 agree) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study assessing human readers with and without AI assistance was not explicitly mentioned or performed. The study described focuses on the standalone performance of the Quantra software against a consensus ground truth.

6. If a Standalone (Algorithm Only) Performance Study Was Done

Standalone Performance Study: Yes, a standalone performance study of the algorithm without human-in-the-loop was performed. The tables clearly show the Quantra 2.2 software's performance (Quantra 2.2- QDC 2D and Quantra2.2 – QDC Tomo) against the BI-RADS 5th Ed. ground truth.

7. The Type of Ground Truth Used

Ground Truth Type: Expert consensus. Specifically, it was the "5 radiologists' consensus assessment of BI-RADS 5th Edition categories."

8. The Sample Size for the Training Set

The provided document does not specify the sample size for the training set. It only discusses the testing against an independent dataset.

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

The provided document does not specify how the ground truth for the training set was established, as details about the training set itself are absent.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 20, 2017

Hologic, Inc. Neil Kelly Principal Regulatory Affairs Specialist 36 Apple Ridge Road DANBURY, CT 06810

Re: K163623

Trade/Device Name: Quantra™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 20, 2016 Received: December 22, 2016

Dear Neil Kelly:

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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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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.

Robert Ocks

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) K163623

Device Name Quantra™M

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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Traditional 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92

Date Prepared:	October 05, 2017
Manufacturer:	Hologic, Inc.36 Apple Ridge RoadDanbury, CT 06810 USA
Est. Registration #:	1220984
Contact Person:	Neil KellyManager, Regulatory AffairsPhone: (508) 263-8634

Identification of the Device:

Proprietary/Trade Name:	Quantra™
Software Version:	2.2
Classification Name:	System, Image Processing, Radiology
Regulatory Number:	21 CFR 892.2050
Product Code:	LLZ
Device Class:	Class II
Review Panel:	Radiology

Identification of the Legally Marketed Predicate Device:

Trade name:	Quantra™
Software Version:	2.1
Classification Name:	System, Image Processing, Radiology
Regulatory Number:	21 CFR 892.2050
Product Code:	LLZ
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Hologic, Inc.
Clearance:	K142037 (cleared October 10, 2014)

Device Description:

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mammographic image. Abnormal lesions also appear bright on a mammogram and can be obscured or masked by fibroglandular tissue.

Indications for Use:

Standards:

IEC 62304:2006 - Medical Device Software - Software Life Cycle Process ISO 14971:2012 – Medical Devices – Application of Risk Management to Medical Devices

Comparison with Predicate Device:

The focus of this submission is to introduce improvements in the proposed Quantra software algorithm to align with ACR BI-RADS® Atlas (Fifth Edition, 2013), and to enhance the accuracy of breast composition estimation. To the end user the proposed Ouantra software is still used in the exact same way as the predicate Quantra software (K142037). The differences are inherent to the algorithm and reported calculations.

Substantial Equivalence:

	QuantraSW Version 2.1Predicate (K142037)	QuantraSW Version 2.2(Proposed)	Comparison
Indicationsfor Use	Quantra™ is a softwareapplication intended for use withimages acquired using digitalbreast x-ray systems. Quantracalculates volumetric breastdensity as a ratio offibroglandular tissue and totalbreast volume estimates.Quantra also provides areabreast density as a ratio of	The Quantra™ softwareapplication is intended for usewith mammographic imagesacquired using digital breast x-ray systems. The Quantrasoftware segregates breastdensity into categories, whichmay be useful in the reporting ofconsistent BI-RADS® breastcomposition categories as	Similar
	fibroglandular tissue area andtotal breast area estimates.Quantra segregates breastdensity into categories, whichmay be useful in the reporting ofconsistent BI-RADS® breastcomposition categories asmandated by certain stateregulations. The Quantra resultsfor each image, breast, andsubject, are intended to aidradiologists in the assessment ofbreast tissue composition.Quantra produces adjunctiveinformation; it is not aninterpretive or diagnostic aid.	mandated by certain stateregulations. The Quantrasoftware reports a result for eachsubject, which is intended to aidradiologists in the assessment ofbreast tissue composition. TheQuantra software producesadjunctive information; it is nota diagnostic aid.
Level ofConcern	Moderate	Moderate	Same
InputModality	Digital x-ray breast images	Digital x-ray breast images	Same
SoftwareProduct	Yes	Yes	Same
ReportableInformation	Fibroglandular (dense) Tissue Volume Total Breast Volume Volumetric Breast Density Area Breast Density Volume of Fibroglandular Tissue Score Volumetric Breast Density Score Estimate of Breast Density (integer) Estimate of Breast Density (fractional)	Quantra Generated Breast Density Category	Similar. Usesdistribution ofglandulartissue ratherthan density ofglandulartissue whenassessingbreastcomposition.
Statisticalcomparisonto areferencepopulation	Yes	Yes	Same, with theproposeddevice alsobeingcomparedagainst a
			dataset scored to BI-RADS 5th edition.
BI-RADS® Atlas	Yes, 4th Edition 2003	Yes, 5th Edition 2013	Similar, with enhancements
Brest Composition Estimates	Yes, displayed as 1, 2, 3 and 4	Yes, displayed as a, b, c, d	Similar, with enhanced accuracy

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Summary of Testing:

Non-clinical (Bench) testing has been performed using retrospectively collected images of 4view screening negative cases. The proposed Quantra software (Version 2.2) was tested against an independent data set of 230 studies, for which the 5 radiologists' consensus assessment of BIRADS 5th Edition categories are known.

Quantra 2.2 2D Fatty vs. Dense

	Quantra 2.2- QDC 2D
		Fatty(a+b)	Dense(c+d)	Per categorytotal	Accuracy
BI-RADS- 5thEd.	Fatty(a+b)	105	8	113	92.9%
	Dense(c+d)	1	116	117	99.1%
			Total	230

Quantra 2.2 Tomo Fatty vs. Dense

	Quantra2.2 – QDC Tomo (3D Center Projection)
	Fatty(a+b)	Dense(c+d)	Per categorytotal	Accuracy
BI-RADS- 5thEd.	Fatty(a+b)	104	9	113	92.0%
	Dense(c+d)	7	110	117	94.0%
		Total	230

No animal studies or clinical studies were performed.

Conclusion:

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the proposed Quantra software (version 2.2) is substantially equivalent to the predicate Quantra software (version 2.1).

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).