QSM software (QSMetric™) is intended for use in the post-acquisition image enhancement of 3D MR images of the brain acquired using a gradient-echo sequence at 1.5T, 3T and 7T field strengths. QSM uses phase information to enhance contrast between tissues presenting magnetic susceptibility differences, such as deoxygenated blood, iron or calcium deposits. When used in combination with other clinical information, QSM may aid the qualified physicians in visualizing tissue structures with magnetic susceptibility contrasts and measuring their susceptibility values.

Device Description

The product QSMetric™, also referred to as QSM software, postprocesses gradient echo magnetic resonance (MR) images to depict tissue magnetic susceptibility contrast (local difference). Tissue susceptibility contrast sources include highly paramagnetic iron presented in deoxyhemoglobin, ferritin and hemosiderin, and diamagnetic calcification. Susceptibility contrast material of tissue in the MR scanner generates its own magnetic field according to the convolution law in magnetism. This tissue field with its dispersion in space causes MR image signal magnitude loss, creating contrasts in magnitude images. Therefore, the magnitude image is commonly used to indicate the presence of nearby tissue susceptibility contrast.

In addition to magnitude images, a gradient echo MR scan results in also phase images. The tissue field causes MR image signal phase accrual, creating contrasts in phase images. The phase image of gradient echo MR data is the product of echo time and tissue field. Accordingly, the phase images from a gradient echo MR scan is processed using QSM to enhance the depiction of tissue susceptibility contrasts.

QSM software works in conjunction with any FDA cleared third-party DICOM viewer as an image postprocessing solution in radiological service.

AI/ML Overview

The provided text details the FDA 510(k) clearance for the QSM software (QSMetric™) but does not contain a specific "acceptance criteria table" or the full study details typically found in a clinical study report. The document focuses on demonstrating substantial equivalence to a predicate device (SWIp from Philips).

However, I can extract the information provided about the device's performance, the studies conducted, and how ground truth was established, to the best of what's available in the text.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

As a specific table of "acceptance criteria" with quantitative metrics is not explicitly provided in the document for the device's performance itself (e.g., sensitivity, specificity, accuracy for a diagnostic task), the information below is inferred from the language used in the "SE-Nonclinical performance data" and "SE-Clinical performance data" sections. The acceptance criteria described are primarily related to engineering performance testing and clinical user needs testing to demonstrate substantial equivalence to the predicate, rather than direct diagnostic performance against a gold standard for a specific clinical condition.

Acceptance Criterion (Inferred from text)	Reported Device Performance and Conclusion
Nonclinical Performance (Engineering Testing)
- Consistent production of results according to intended use.	"All predefined acceptance criteria for the engineering performance testing were met for all test cases across different scanner manufacturers. The results from the nonclinical testing performed on the QSM software demonstrate that the QSM software produces results consistently according to its intended use..."
- Substantially equivalent to combining information from SWIp magnitude	"...and is substantially equivalent to combining information from SWIp both magnitude and phase images output from the predicate device."
and phase images (predicate).
Clinical Performance (Clinical User Needs Testing)
- Acceptable output image quality.	"All predefined acceptance criteria for clinical validation testing, including clinical user needs testing, as a part of the QSM performance validation testing efforts, were met across all test cases. The results of the clinical validation related testing performed on the QSM software demonstrate that output image quality are acceptable, all clinical user needs are met..."
- All clinical user needs met.	"...all clinical user needs are met..."
- Substantially equivalent to combining information from SWIp magnitude	"...and QSM is substantially equivalent to combining information from SWIp both magnitude and phase images output from the predicate device." The document explicitly states "The subject device of this premarket notification, QSM software, did not require clinical studies to support substantial equivalence to the predicate device," indicating that the "clinical validation testing" mentioned was not a traditional clinical trial assessing diagnostic accuracy, but rather verification of user needs and perceived image quality in a clinical context.
and phase images (predicate).

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated with a specific number of cases for either non-clinical or clinical validation. The text uses general terms like "all test cases" for both engineering performance testing and clinical validation testing.
- Data Provenance: Not specified (e.g., country of origin). The document indicates testing across "different scanner manufacturers" (General Electric, Philips, Siemens, and United Imaging), implying data from various MRI systems, but not their geographical origin. It does not explicitly state whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The ground truth, as described, was primarily based on the expected output and performance of an image processing software in comparison to a predicate device, rather than a diagnostic 'ground truth' established by expert consensus for a specific disease or condition. The "clinical user needs testing" suggests involvement of users (presumably qualified physicians as per the intended use), but the number and specific qualifications for establishing 'ground truth' for this type of software validation are not detailed.
Adjudication method for the test set:
- Not applicable/Not specified. Given the nature of the software (image enhancement/post-processing for visualization and measurement of susceptibility values), typical diagnostic adjudication methods (like 2+1 or 3+1 for disease presence) are not described as part of the validation presented. The "acceptance criteria" were met through engineering and user needs testing, implying a different validation approach.
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:
- No. The document explicitly states: "The subject device of this premarket notification, QSM software, did not require clinical studies to support substantial equivalence to the predicate device." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or presented.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "nonclinical performance data" and "engineering performance testing" describe the algorithm's performance in producing consistent results and being substantially equivalent to the predicate, which would involve standalone assessment of the software's output. The "clinical validation testing" focused on "output image quality" and "clinical user needs met," which also points to an assessment of the algorithm's output, though likely interpreted by human users.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's validation appears to be:
  - For engineering performance: The expected computational output and consistency across different scanner types, and the comparison to the existing, cleared predicate device's output (SWIp magnitude and phase images).
  - For "clinical validation" (user needs): Acceptable image quality and meeting predefined clinical user needs, likely assessed qualitatively or semi-quantitatively by qualified personnel, in comparison to the output of the predicate device. It's not a ground truth for a disease diagnosis but for the quality and utility of the enhanced images.
The sample size for the training set:
- Not specified. The document outlines verification and validation procedures but does not provide details on the training set or its size, which is typical for a 510(k) summary focused on substantial equivalence rather than detailed algorithm development.
How the ground truth for the training set was established:
- Not specified. As the training set size or details are not provided, the method for establishing its ground truth is also not mentioned.

Summary

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July 22, 2021

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Medimagemetric LLC % Yi Wang President & CEO 455 Main Street, #7H NEW YORK NY 10044

Re: K210415

Trade/Device Name: QSM software, QSMetric"™ Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: June 21, 2021 Received: June 21, 2021

Dear Yi Wang:

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); 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 (QS)

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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

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Indications for Use

510(k) Number (if known) K210415

Device Name

QSM software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K210415

510(k) Summary (21 CFR 807.92)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

General information

Submitter:	Medimagemetric LLC
	171 Floral Ave
	Johnson City, New York 13790
Contact	Yi Wang
	Tel: 929.314.2988
Prepared on:	2/8/2021

Device name and classification

Trade name:	QSMetric™
Common name:	Radiological image processing software
Classification:	Magnetic resonance diagnostic device (21 CFR 892.1000, Product code LNH)

Legally marketed device of substantial equivalence (SE) - predicate device

SWIp from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (595 MINER RD, Cleveland, OH 44143), cleared for US commercialization via K131241 on 8/30/2013.

Device description

QSM software works in conjunction with any FDA cleared third-party DICOM viewer as an image postprocessing solution in radiological service.

Intended use

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susceptibility differences, such as deoxygenated blood, iron or calcium deposits. When used in combination with other clinical information, QSM may aid the qualified physicians in visualizing tissue structures with magnetic susceptibility contrasts and measuring their susceptibility values.

Technological characteristics: substantial equivalence between QSM and predicate SWIp QSM's fundamental technological characteristics are substantially equivalent to those of the predicate device SWIp (K131241) as described in this submission. The substantial equivalence between QSM and SWIp are noted in the following table.

Featuresspecifications	Subject device	Predicate device	QSM-SWIpSE
Regulationname	Magnetic resonancediagnostic device	Magnetic resonance diagnosticdevice	Yes
Prescriptionuse	Yes	Yes	Yes
Intended use	QSM software (QSMetricTM )is intended for use in thepost-acquisition imageenhancement of 3D MRimages of the brain acquiredusing a gradient-echosequence at 1.5T, 3T and 7Tfield strengths. QSM usesphase information to enhancecontrast between tissuespresenting magneticsusceptibility differences,such as deoxygenated blood,iron or calcium deposits.When used in combinationwith other clinicalinformation, QSM may aidthe qualified physicians invisualizing tissue structureswith magnetic susceptibilitycontrasts and measuring theirsusceptibility values.	SWIp is a software option intendedfor use on Achieva and Ingenia 1.5T& 3.0T MR Systems. It's indicatedfor magnetic resonance imaging ofthe brain. SWIp is a technique usingphase information to enhancecontrast between tissues presentingsusceptibility differences, such asdeoxygenated blood or some mineraldeposits (e.g. calcium deposits). Dueto this contrast enhancement, SWIpimages are sensitive for structurescontaining venous blood such ascerebral venous vasculature. Whenused in combination with otherclinical information, SWIp may helpthe expert radiologist in thediagnosis of various neurologicalpathologies.	Yes
MRI system	MRI systems from GeneralElectric, Philips, Siemens,and United Imaging	3.0T and 1.5T, Achieva and IngeniaMRI systems from Philips	Yes
Input data	3D gradient echo magnitudeand phase images, or real andimaginary images	gradient echo magnitude and phaseimages	Yes
Phaseprocessing	Phase unwrappingBackground field removal	Phase unwrappingBackground field removal	Yes
	Dipole phase modeling tomeasure susceptibilitycontrasts with phase andmagnitude info	Spectral phase modeling to enhancesusceptibility contrasts with phaseand magnitude info
Userinterface	Automated postprocessing	Automated postprocessing	Yes
Output	Tissue susceptibility contrastmap	Images with enhanced contrastsbetween tissues with susceptibilitydifferences	Yes

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SE-Nonclinical performance data

The following design control, risk management and quality assurance methodologies were utilized to develop QSM software:

Quality policy and system establishment
Software requirements specification review ●
Software design review ●
Risk management ●
Traceability analysis ●
Verification testing at unit and integration levels ●
Validation testing on simulated use and nonclinical use. .

Software documentation for Moderate Level of Concern software per the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included in this premarket notification submission. The QSM software has been tested in accordance with Medimagemetric's verification and validation procedures.

All predefined acceptance criteria for the engineering performance testing were met for all test cases across different scanner manufacturers. The results from the nonclinical testing performed on the QSM software demonstrate that the QSM software produces results consistently according to its intended use and is substantially equivalent to combining information from SWIp both magnitude and phase images output from the predicate device.

SE-Clinical performance data

The subject device of this premarket notification, QSM software, did not require clinical studies to support substantial equivalence to the predicate device. All predefined acceptance criteria for clinical validation testing, including clinical user needs testing, as a part of the QSM performance validation testing efforts, were met across all test cases. The results of the clinical validation related testing performed on the QSM software demonstrate that output image quality are acceptable, all clinical user needs are met, and QSM is substantially equivalent to combining information from SWIp both magnitude and phase images output from the predicate device.

Conclusions from nonclinical and clinical performance data

The subject device and the predicate device are substantially equivalent, with respect to intended use, instructions for use, design features, technological characteristics, manufacturing methods,

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Image /page/6/Picture/0 description: The image shows the logo for MedImageMetric. The logo consists of the acronym "MIM" in a red square, followed by the words "MedImageMetric" in blue and black. The word "MedImage" is in blue, and the word "Metric" is in black and red.

performance criteria, safety, and effectiveness. The subject device is substantially equivalent to the predicate device (K131241) noted herein.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.