QuantX is a quantitative image analysis software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric and surface area analysis. These imaging features are then displayed to the user in a dedicated analysis panel on the display monitor.

When interpreted by a skilled physician, this device provides information that may be useful for screening and diagnosis. Patient management decisions should not be made based solely on the results of QuantX analysis.

QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report.

Limitations: QuantX is not intended for primary interpretation of digital mammography images.

Device Description

QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions. After MR images are acquired from a third-party acquisition device, they can be loaded into the QuantX database manually, or automatically if connected to a DICOM-compatible device. Users then select and load the patient case to use the QuantX software tools in the examination of the images. Different types of MR sequences (T1, DCE, T2, DWI, etc.) can be viewed at the same time as mammography or ultrasound images from the same patient.

A variety of viewing tools are available to users. The MR images can be examined under different image planes (axial, sagittal, and coronal) as well as different image time points and slices. Users can use keyboard shortcuts or a scrolling mechanism to navigate through MR image slices. Colored axes serve as slice location markers for ease of pinpointing regions of interest (ROI). Images can be panned, changed in contrast, zoomed in or out. and measured. The Colormap feature visualizes contrast uptake (enhancement) studies, and a time intensity curve can be viewed for any location on the MR image.

QuantX includes image registration, and automated segmentation and analysis functions, based on a seed point indicated by the user. Users can select a ROI manually from the MR image, or use the automatic segmentation tool to obtain and accept a ROI, for input to the QuantX analytics.

The QuantX analytics display the QI Most Enhancing Curve, volume and surface area of the specified region. A user experienced with the significance of such data will be able to view and interpret this additional information during the diagnosis of breast lesions.

AI/ML Overview

The provided text describes the QuantX device and its FDA 510(k) summary. However, it does not contain the specific details required to fully address all sections of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

The document mentions "Verification testing of lesion segmentation on MR image data" and "Verification that all measurements and BIRADS reporting were recorded correctly," which implies that there were acceptance criteria for these functions. However, the specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or error bounds) and the reported device performance against these criteria are not provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. The summary only states that nonclinical tests were performed, including "Verification testing of lesion segmentation on MR image data." It does not specify the number of cases or the nature of the data used for these verification tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document states, "OuantX is a quantitative image analysis software device used to assist radiologists... When interpreted by a skilled physician, this device provides information that may be useful for screening and diagnosis." This implies an assistive role for radiologists. However, there is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any data on how much human readers improve with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not explicitly describe a standalone performance study. While it mentions "automated segmentation and analysis functions," the overall context emphasizes its role in assisting radiologists. Therefore, standalone performance details are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document mentions "Verification testing of lesion segmentation on MR image data" and "Verification that all measurements... were recorded correctly." This implies that there were reference standards for these tests, likely based on expert annotations or ground truth derived from clinical knowledge. However, the specific type of ground truth (e.g., expert consensus, pathology, long-term outcomes) is not explicitly stated.

8. The sample size for the training set

This information is not available in the provided document. The document describes the device's functions but does not delve into the details of its development or training.

9. How the ground truth for the training set was established

This information is not available in the provided document.

Summary of available and missing information:

The provided 510(k) summary focuses on establishing substantial equivalence based on technological characteristics and general non-clinical testing. It highlights the device's intended use to assist radiologists and its features like image registration, segmentation, and volumetric/surface area analysis. However, it lacks the detailed performance metrics, study designs (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), and comparative effectiveness data that would be found in a comprehensive clinical validation study report. These types of details are often found in the full 510(k) submission, but not typically in the public summary document.

Summary

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Public Health Service

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

May 17, 2017

Quantitative Insights, Inc. % Mr. Robert Tomek Chief Technology Officer 1452 E 530 Street CHICAGO IL 60615

Re: K170195 Trade/Device Name: QuantX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 21, 2017 Received: February 21, 2017

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. 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

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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.

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.

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) K170195

Device Name QuantX

Indications for Use (Describe)

Limitations: QuantX is not intended for primary interpretation of digital mammography images.

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 As required by 21 CFR §807.92(c)

Submitter

Manufacturer:	Quantitative Insights, Inc.
Address:	1452 E. 53rd StreetChicago, IL 60615

Contact Person:
Contact Person Title:
Telephone:
Email:

Robert Tomek Chief Technology Officer 872.529.2239 rtomek@guantinsights.com

Date Prepared:

May 10, 2017

Device Information

Trade Name: QuantX Common Name: Image Processing Software Classfication Name: Picture archiving and communications system Product Code: LLZ

LEGALLY MARKETED PREDICATE DEVICE A.

Legally marketed predicate device is: CADStream Version 5 - K081556, K092954

B. DEVICE DESCRIPTION

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C. INDICATIONS FOR USE

OuantX is a quantitative image analysis software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric and surface area analysis. These imaging features are then displayed to the user in a dedicated analysis panel on the display monitor.

OuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report.

Limitations: QuantX is not intended for primary interpretation of digital mammography images.

An assessment has been made on the differences in indications between QuantX and the predicate device, and it has been determined that these changes do not raise any new questions regarding the safety and effectiveness of the device.

TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by D. 807.92(a)(6)

QuantX has the following same technological characteristics as its predicate device. It is an MRI data post-processing software device, and is DICOM compatible. These similar features include:

Visualization tools - standard 2D and 3D image viewing tools. MIPs. reformats
Analysis registration, subtractions, kinetic analysis, parametric image maps, ● apparent diffusion coefficient (ADC) maps, automatic and manual segmentation tools
Standardized reporting tools incorporating user selected finding and assessment ●
User interface and interaction tools that enhance workflow efficiency .

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. Communication and storage functions including DICOM standard interfaces
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 does not support coil inhomogeneity correction
. Subject does not support interventional planning
Workflow efficiencies are implemented differently in the subject and predicate . devices
. In addition to volume computation, the subject device includes a surface area computation which provides an additional indicator of lesion size

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

QuantX has been successfully tested for its software requirements and features.

Nonclinical tests included:

Verification of the proper loading, display, and manipulation of MR image data. ●
. Verification of the proper loading, display, and manipulation of Mammographic and Ultrasound image data.
Verification that the calculation and display of kinetic colormaps were accurate ● on MR image data.
Verification testing of lesion segmentation on MR image data.
Verification that all measurements and BIRADS reporting were recorded correctly.
Validation testing demonstrates the device conforms to user needs and intended ● use.

F. CONCLUSION

OuantX provides features to aid radiologists in the visualization and analysis of breast MR images. The potential hazards, including risk analysis and design considerations, have been examined and incorporated into the software development process.

This 510(k) Premarket Notification provides adequate information to establish substantial equivalence 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).