SyMRI by SyntheticMR AB | FDA 510(k) Summary

SyMRI is a post-processing software medical device intended for use in visualization of the brain. SyMRI analyzes input data from MR imaging systems. SyMRI utilizes data from a multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD). SyMRI can generate multiple image contrasts from the parametric maps. SyMRI enables post-acquisition image contrast SyMRI is indicated for head imaging.

SyMRI is also intended for automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images. Brain tissue volumes are determined based on modeling of parametric maps from MDME images.

When interpreted by a trained physician, SyMRI images can provide information useful in determining diagnosis. SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR).

Device Description

AI/ML Overview

The provided text from the FDA 510(k) clearance letter for SyMRI does not contain the detailed study information required to answer all parts of your request. This document is a clearance letter, not a clinical study report. It confirms the device's substantial equivalence to a predicate device but typically does not include the granular details of the validation studies (like specific acceptance criteria, sample sizes for test sets, expert qualifications for ground truth, or MRMC study results).

However, I can extract and infer some information based on the typical content of such submissions and the scope of the device described.

Based on the provided text, here's what can and cannot be answered:

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: This document does not detail specific acceptance criteria or quantitative performance metrics.
Sample sized used for the test set and the data provenance: No information on test sample size or data origin (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method: Not specified.
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: Not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated, though the nature of the device (post-processing software) implies elements of standalone processing.
The type of ground truth used: Not explicitly stated (e.g., expert consensus vs. pathology).
The sample size for the training set: Not specified.
How the ground truth for the training set was established: Not specified.

Information that can be inferred or partially addressed from the provided text:

While the document doesn't explicitly state acceptance criteria in a table format, the core "acceptance" for 510(k) clearance is substantial equivalence to a predicate device. This means the new device is as safe and effective as a legally marketed device. The performance data submitted to demonstrate this equivalence would typically include validation of the features described.

Here's an attempt to structure an answer, acknowledging the limitations of the provided text:

Description of Device Acceptance Criteria and Supporting Study (Based on Inference and Typical 510(k) Scope)

Device Name: SyMRI
510(k) Number: K173558
Device Type: Post-processing software medical device for visualization of the brain, generation of parametric maps (R1, R2, PD), multiple image contrasts, and automatic labeling/volumetric quantification of brain tissues.

General Acceptance Premise (for 510(k) Clearance):
The primary acceptance criterion for 510(k) marketing clearance is demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness. For a software device like SyMRI, this typically involves validating that its outputs (parametric maps, derived contrasts, tissue segmentations, and volume quantifications) are accurate and reliable, and that its use does not introduce new safety concerns compared to the predicate.

Given the device's stated functions, the studies would likely have aimed to demonstrate:

Accuracy of Parametric Maps (R1, R2, PD): The generated relaxation rates and proton density values align with expected values from the MR physics and potentially a "gold standard" or highly controlled measurements.
Fidelity of Derived Image Contrasts: The synthetic images generated (e.g., T1, T2, FLAIR-like) are diagnostically equivalent to conventionally acquired images of the same type.
Accuracy of Brain Tissue Segmentation and Volumetric Quantification: The software correctly identifies and quantifies different brain tissues (e.g., white matter, gray matter, CSF) and that these measurements are consistent and reproducible.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Function	Acceptance Criteria (Inferred from device function & 510(k) requirement)	Reported Device Performance (Not detailed in provided 510(k) letter)
Parametric Map Generation (R1, R2, PD)	Demonstrated accuracy and precision of derived R1, R2, and PD values (e.g., within a predefined tolerance of a reference standard).	Not reported in the clearance letter. (Actual performance data would be in the original 510(k) submission, likely including bias, precision, linearity).
Synthetic Image Contrast Generation	Diagnostic equivalence of synthetic images to conventionally acquired MR images (e.g., qualitative assessment by radiologists, quantitative similarity metrics).	Not reported in the clearance letter. (Would typically involve metrics like SSIM, PSNR or expert agreement scores).
Automatic Brain Tissue Segmentation & Quantification	Demonstrated accuracy of tissue segmentation (e.g., Dice similarity coefficient vs. ground truth) and reproducibility of volumetric measurements.	Not reported in the clearance letter. (Would likely include Dice scores, volumetric error percentages, correlation with manual segmentation).
Safety and Compatibility	No new safety concerns identified; compatibility with stated MR imaging systems.	Demonstrated through testing (e.g., electrical safety, software validation).

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

Sample Size: Not specified in the provided document.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not specified.
Qualifications: "When interpreted by a trained physician" is mentioned in the Indications for Use, implying that the ground truth for clinical interpretation or validation would involve qualified medical professionals, most likely radiologists given the nature of MR imaging. Specific experience levels are not mentioned.

4. Adjudication Method for the Test Set

Not specified.

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

Not specified if an MRMC study was performed. The letter states the device "can provide information useful in determining diagnosis" and "should always be used in combination with at least one other, conventional MR acquisition." This phrasing suggests a component of human interpretation is always involved, but it doesn't detail a comparative study setup.
Effect Size: Not applicable as the conduct of an MRMC study is not confirmed or detailed.

6. Standalone (Algorithm Only) Performance

The device is "post-processing software" that "analyzes input data" and "generates parametric maps" and "automatic labeling, visualization and volumetric quantification." This describes the algorithm's standalone function in processing data and producing outputs. The performance of these standalone functionalities (e.g., accuracy of parameter estimation, segmentation accuracy) would have been evaluated, though specific metrics are not in this letter.
The "Indications for Use" clearly states, "SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR)" and "When interpreted by a trained physician." This indicates that while the algorithm has standalone processing capabilities, its clinical use is intended to be human-in-the-loop and complementary to other imaging.

7. Type of Ground Truth Used

Not explicitly stated. For parametric map validation, a "gold standard" might be phantom data or highly controlled reference scans. For segmentation and volumetric quantification, ground truth would typically be established by:
- Expert Consensus: Manual segmentation by one or multiple expert readers (e.g., radiologists, neuroanatomists), potentially with arbitration.
- Pathology/Histology: Less likely for general brain imaging, but possible for specific validation of tissue characteristics if biopsies were involved (highly unlikely for a general imaging device).
- Outcomes Data: Not typically the primary ground truth for basic image processing accuracy, but could be part of broader clinical utility studies.

8. Sample Size for the Training Set

Not specified.

9. How Ground Truth for the Training Set Was Established

Not specified. Assuming a machine learning component (common for "automatic labeling" and "volumetric quantification"), the ground truth for training would likely be established in a similar manner to the test set ground truth (e.g., manual expert annotations), performed on a distinct dataset.

Summary

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SyntheticMR AB % Mr. Raymond Kelly Consultant Licensale, Inc. 68 Southwoods Terrace SOUTHBURY CT 06488

January 26, 2018

Re: K173558

Trade/Device Name: SyMRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LLZ Dated: November 10, 2017 Received: November 17, 2017

Dear Mr. 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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) K173558

Device Name SyMRI

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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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.