The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.

Device Description

The QuantX Breast MRI Biopsy Guidance Plugin assists users in planning MRI quided interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion. Its primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional. The QuantX Breast MRI Biopsy Guidance Plugin may be used in either the SE or Advanced version of QuantX, a software program used for the display and analysis of medical images.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. The document is a 510(k) premarket notification summary for the QuantX Breast MRI Biopsy Guidance Plugin, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting explicit acceptance criteria and corresponding performance study results in the format requested.

However, the "Nonclinical Performance Data Testing and Reviews" section (1.7) lists various verification and validation tests performed. I can infer potential "acceptance criteria" from these tests regarding the functionality and accuracy of the device. The reported device performance is indicated by the statement that the tests were "successfully tested" and "demonstrates that the device conforms to user needs and intended use."

Here's an attempt to structure the available information as requested, though many fields will be marked as "Not Provided" or inferred.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the document (510(k) summary demonstrating substantial equivalence), explicit numerical acceptance criteria and precise performance metrics are not detailed. The "performance" is generally described as "verification of correct" or "successful testing."

Acceptance Criteria (Inferred from Verification Tests)	Reported Device Performance
Proper activation of biopsy guidance mode and interface display	Successfully tested; achieved proper activation and display.
Proper creation of needle block images	Successfully tested; achieved proper creation.
Proper loading of image series for biopsy guidance	Successfully tested; achieved proper loading.
Complete and correct selection of grid type variables	Successfully tested; ensured complete and correct selection.
Complete and correct needle type variables	Successfully tested; ensured complete and correct selection.
Correct fiducial marker image-space coordinates	Successfully tested; verified correct coordinates.
Correct size of grid image overlay and location	Successfully tested; verified correct size and location.
Correct lesion marker overlay display and image-space coordinates	Successfully tested; verified correct display and coordinates.
Proper display of selected breast, grid cell, and block hole	Successfully tested; achieved proper display.
Proper display of needle block image and needle depth	Successfully tested; achieved proper display.
Correct patient orientation indicators	Successfully tested; verified correct indicators.
Correct lesion depth calculation (by comparison to predicate)	Successfully tested; verified correct calculation.
Correct needle block hole (by comparison to predicate)	Successfully tested; verified correct hole.
Correct grid cell (by comparison to predicate)	Successfully tested; verified correct grid cell.
Guidance worksheet output	Successfully tested; verified output.
Conformance to user needs and intended use	Validation testing demonstrates conformance.

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

Sample Size for Test Set: Not provided. The document mentions "Nonclinical tests" but does not specify the number of cases or images used for testing.
Data Provenance: Not provided. The origin of the data (e.g., country of origin, retrospective or prospective) is not mentioned. Given it's a software for MRI guidance, the data would likely be MRI scans.

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

Number of Experts: Not provided.
Qualifications of Experts: Not provided. The study refers to "comparison to predicate" for some verifications, suggesting the predicate device's output or established methods served as a reference, but does not detail human expert involvement in establishing ground truth for the test data itself.

4. Adjudication Method for the Test Set

Adjudication Method: Not provided. There is no mention of independent expert review, consensus, or other adjudication processes for the test results.

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

MRMC Study Done: No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The focus is on the software's functional correctness and substantial equivalence to a predicate device.
Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study was performed or reported.

6. Standalone (Algorithm Only) Performance Study

Standalone Study Done: Yes, implicitly. The listed "Nonclinical tests" appear to evaluate the algorithm's functionality and accuracy in a standalone manner (e.g., "Verification of correct lesion depth calculation," "Verification of correct fiducial marker image-space coordinates"). The results are described as successful.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for several verification steps was established by comparison to the predicate device. For other functional tests, the ground truth was implied by the Expected Results of the software's specified functionality (e.g., "proper activation," "correct display"). There is no mention of pathology, expert consensus on patient outcomes, or other clinical ground truth methods for the non-clinical tests.

8. Sample Size for the Training Set

Sample Size for Training Set: Not provided. The document focuses on verification and validation of a software feature, not on machine learning model training. It's unclear if the "biopsy guidance plugin" itself involves machine learning that would require a distinct training set. If it's a computational algorithm for geometry calculations, a training set might not be conventionally applicable.

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

How Ground Truth Was Established for Training Set: Not provided, and likely not applicable given the apparent nature of the device as a computational guidance tool rather than a machine learning classifier.

Summary

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November 8, 2019

Qlarity Imaging, LLC % Mr. Robert Tomek Chief Technology Officer 222 W Merchandise Mart Plaza Suite 1230 CHICAGO IL 60654

Re: K191959

Trade/Device Name: QuantX Breast MRI Biopsy Guidance Plugin Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 19, 2019 Received: October 16, 2019

Dear Mr. Tomek:

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

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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) 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 (OS) 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,

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

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Indications for Use

510(k) Number (if known) K191959

Device Name

QuantX Breast MRI Biopsy Guidance Module

Indications for Use (Describe)

The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.

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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Premarket Notification 510(k) Summary

1.1 Submitter

Manufacturer:	Qlarity Imaging, LLC
Address:	222 W Merchandise Mart Plaza #1230
	Chicago, IL 60654
Contact Person:	Robert Tomek
Contact Person Title:	Chief Technology Officer
Telephone:	872.529.2239
Email:	rtomek@qlarityimaging.com
Date Prepared:	August 28, 2019

1.2 Device Information

510(k) Submission type: Traditional

Device Trade Name: QuantX Breast MRI Biopsy Guidance Plugin

Device Common Name: Image Processing System

510(k) Submitter: Qlarity Imaging, LLC

Classification Regulation: 21 CFR 892.2050

Classification Regulation Name: Radiology

Regulatory Class: Class II

Classification Product Code: LLZ

1.3 Leqally Marketed Predicate Device

The legally marketed predicate device is:

Device Name	ManufacturerName	510(k)References	ProductCode	Classification
DynaCAD	MRI DevicesCorporation	K041286	LLZ	Class II

1.4 Device Description

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lts primary goal is to identify where and how deep a biopsy needle should be inserted into an imaged breast in order to strike a targeted lesion or region of interest, as chosen by a trained medical professional.

The QuantX Breast MRI Biopsy Guidance Plugin may be used in either the SE or Advanced version of QuantX, a software program used for the display and analysis of medical images.

1.5 Indications for Use

The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI quided interventional procedures.

1.6 Technological Characteristics

The QuantX Breast MRI Biopsy Guidance Plugin has the following same technological characteristics as the predicate device.

User-initiated selection of target breast (left or right) and direction of ● approach (medial or lateral).
Customized image display depending on side and direction of approach. ●
User-initiated placement of fiducial marker and biopsy grid. ●
User-initiated selection of needle size and block combination within the biopsy panel.
Display of image overlay for fiducial marker and biopsy grid. ●
Display of image overlay for target region of interest location and sample ● needle trajectory.
Calculation and display of coordinates and depth to reqion of interest. .

The following technological differences exist between the subject and predicate device; these differences do not affect the safety and effectiveness of the device when used as labeled:

Subject device is a plugin that can be used in either the SE or Advanced versions of QuantX, a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up. The predicate device is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. Additionally, the predicate device assists users in planning MRI guided interventional procedures.
These differences do not affect the safety and effectiveness of the device when used as labeled.

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1.7 NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEWS - as required by 807.92(b)(1)

The QuantX Breast MRI Biopsv Guidance Plugin has been successfully tested for its software requirements and features. Nonclinical tests included:

Verification of proper activation of biopsy guidance mode and interface . display;
Verification of proper creation of needle block images; ●
Verification of proper loading of image series to be used in biopsy guidance; ●
Verification of complete and correct selection of grid type variables; ●
Verification of complete and correct needle type variables; ●
Verification of correct fiducial marker image-space coordinates;
Verification of correct size of grid image overlay and location;
Verification of correct lesion marker overlay display and image-space ● coordinates;
Verification of proper display of selected breast, grid cell, and block hole;
Verification of proper display of needle block image and needle depth: ●
. Verification of correct patient orientation indicators:
Verification of lesion depth calculation by comparison to predicate; ●
. Verification of correct needle block hole by comparison to predicate;
Verification of correct grid cell by comparison to predicate; ●
Verification of quidance worksheet output; ●
Validation testing demonstrates that the device conforms to user needs and ● intended use.

Based on these tests, we conclude that the subject device is safe and effective and substantially equivalent to the predicate device.

1.8 Conclusion

Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

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).