(312 days)
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-delay, 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 adjustment. SyMRI is indicated for head imaging. 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).
SyMRI allows the user to generate multiple image contrasts from a single acquisition scan. This is accomplished by post-processing a multi-delay, multi-echo acquisition (MDME) into parametric maps. The parametric maps are R1, R2 relaxation rates, and proton density (PD). The inverse relaxation parameters, T1 relaxation time (1/R1), and T2 relaxation time (1/R2) are also provided as parametric maps. The parametric maps can be visualized as contrast weighted MR images, such as T1, T2, PD, and Inversion Recovery (IR) weighted images (including T1-FLAIR, T2-FLAIR, STIR, Double IR, and PSIR weighted images). SyMRI calculates the pixel signal intensity as a function of R1, R2, PD, and desired MR scanner settings, such as echo time (TE), repetition time (TR), and inversion delay time (TI). A number of default settings for TE. TR, and TI are provided, but the user has the ability to change the contrast of the images. SyMRI generates all the different image contrasts from the same parametric maps, derived from the same acquisition. This leads to enhanced image slice registration, owing to the absence of interacquisition patient movement. SyMRI provides the user the ability to change the contrast of the images after the acquisition. This is performed by adjusting the TE, TR, and/or TI parameters post-acquisition, to generate the specific contrast desired.
SyMRI also provides image processing tools to extract the values of the parametric maps per individual pixel, per region of interest, or the entire imaging volume.
SyMRI is intended to be used on MDME sequence data from GE MAGiC.
The provided text describes the SyMRI device and its comparison to the predicate device MAGiC, but it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested. Instead, it makes a general statement about substantial equivalence based on the algorithm and image quality.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or explicitly stated, and note when information is missing.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Additional phantom head to head comparison of R1, R2 and PD parametric maps, which included one contrast of each major synthetic image (T1w, T2w, T2 FLAIR), were performed to compare SyMRI to MAGiC. There was no difference between SyMRI and MAGiC." This implies the acceptance criterion was "no difference" compared to the predicate device, but specific quantitative metrics are not provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No difference in R1, R2, and PD parametric maps compared to MAGiC (predicate device) | "There was no difference between SyMRI and MAGiC." |
| No difference in T1w, T2w, T2 FLAIR synthetic images compared to MAGiC (predicate device) | "There was no difference between SyMRI and MAGiC." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The text mentions a "phantom head to head comparison," implying phantom data, but the number of phantoms or images is not specified.
- Data Provenance: Phantom data (implied). No country of origin is mentioned. The study appears to be a comparative study rather than a retrospective or prospective clinical study on patient data for validation criteria described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not mentioned. The comparison was primarily a technical, quantitative comparison of parametric maps and image modalities between two algorithms, not an assessment by human experts against ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not mentioned. No human adjudication process is described.
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
No, an MRMC comparative effectiveness study is not mentioned as having been performed. The comparison was directly between the SyMRI algorithm and the MAGiC algorithm using phantom data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance comparison was performed. The comparison was of the SyMRI algorithm directly against the MAGiC algorithm for generating parametric maps and synthetic images.
7. The type of ground truth used
The implicit "ground truth" used for comparison was the output of the predicate device, MAGiC. For the specific phantom study mentioned, the "ground truth" was that the parametric maps and synthetic images generated by SyMRI should be indistinguishable from those generated by MAGiC.
8. The sample size for the training set
Not applicable/Not mentioned. The document describes a post-processing software ("SyMRI and MAGiC are the same algorithm for post processing"). It is not a machine learning model in the sense of requiring a "training set" in the context of deep learning. It's an algorithm that generates parametric maps and synthetic images from input MR data.
9. How the ground truth for the training set was established
Not applicable/Not mentioned for the reasons stated above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2017
SyntheticMR AB % Mr. Raymond Kelly Consultant Licensale, Inc. 68 Southwoods Terrrace Southbury CT 06488
Re: K162943
Trade/Device Name: SyMRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 22, 2017 Received: August 21, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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. 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) K162943
Device Name
SyMRI
Indications for Use (Describe)
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-delay, 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 adjustment. SyMRI is indicated for head imaging. 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).
| 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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003 510k Summary
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Date Prepared: August 14, 2017
Applicant:
SyntheticMR AB Storgatan 11 SE-58223 Linköping, Sweden
Contact Person:
Raymond Kelly 68 Southwoods Terrace Southbury, CT 06488 USA Phone: (203) 400-7566
Device Information:
Trade Name: SyMRI® 10 Common Name: Nuclear Magnetic Resonance Imaging System Classification: 21CFR 892.1000 Product Code: LNH Regulatory Class: II
Predicate Device:
MAGiC K161397 (LNH)
Indications for Use
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 multidelay, 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 adjustment. SyMRI is indicated for head imaging.
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
SyMRI allows the user to generate multiple image contrasts from a single acquisition scan. This is accomplished by post-processing a multi-delay, multi-echo acquisition (MDME) into parametric maps. The parametric maps are R1, R2 relaxation rates, and proton density (PD). The inverse relaxation parameters, T1 relaxation time (1/R1), and T2 relaxation time (1/R2) are also provided as parametric maps. The parametric maps can be visualized as contrast weighted MR images, such as T1, T2, PD, and Inversion Recovery (IR) weighted images (including T1-FLAIR, T2-FLAIR, STIR, Double IR, and PSIR weighted images). SyMRI calculates the pixel signal intensity as a function of R1, R2, PD, and desired MR scanner settings, such as echo time (TE), repetition time (TR), and inversion delay time (TI). A number of default settings for TE. TR, and TI are provided, but the user has the ability to change the contrast of the images. SyMRI generates all the different image contrasts from the same parametric maps, derived from the same acquisition. This leads to enhanced image slice registration, owing to the absence of interacquisition patient movement. SyMRI provides the user the ability to change the contrast of the images after the acquisition. This is performed by adjusting the TE, TR, and/or TI parameters post-acquisition, to generate the specific contrast desired.
SyMRI also provides image processing tools to extract the values of the parametric maps per individual pixel, per region of interest, or the entire imaging volume.
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003 510k Summary
SyMRI is intended to be used on MDME sequence data from GE MAGiC.
Comparison of Technological Characteristics
SyMRI and MAGiC are the same algorithm for post processing, MAGiC also includes acquisition. Input data to SyMRI and MAGiC is MDME acquisition. SyMRI and MAGiC both uses a single scan to acquire a multi-delay, multi- echo acquisition (MDME) data to generate parametric maps of R1, R2 relaxation rates, and proton density (PD) This data is used to generate images, which are possible to adjust, even post acquisition. In SyMRI the parametric maps are used to produce the synthetic images - as in MAGiC. SyMRI is the same as MAGiC post processing.
By virtue of its intended use and physical and technological characteristics, SyMRI is substantially equivalent to the predicate devise that has been cleared for marketing in the US. The performance data shows that SyMRI is as safe and effective as the predicate device.
Performance Data Quality and Safety:
SyMRI was designed in compliance with following standards:
- AAMI/ANSI 62304- Medical Device software Software life cycle processes ●
- NEMA PS 3.1 3.20 (2016) DICOM Format ●
- ISO 13485:2012 Quality management systems Requirements for regulatory purposes ●
- ISO 14971:2012 Application of risk management to medical devices ●
- IEC 62366-1:2015 Application of usability engineering to medical devices ●
- IEC82304-1:2016 Health Software Part 1: General requirements for product safety ●
Testing to Support of Substantial Equivalence Determination
Verification and validation was performed according to SyntheticMR processes. Additional phantom head to head comparison of R1, R2 and PD parametric maps, which included one contrast of each major synthetic image (T1w, T2w, T2 FLAIR), were performed to compare SyMRI to MAGiC. There was no difference between SyMRI and MAGiC.
Conclusion
By virtue of its intended use and physical and technological characteristics, SyMRI is substantially equivalent to the predicate device that has been cleared for marketing in the US.
§ 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.