LogoFDA 510(k) Search
K Number
K201616
Device Name
SyMRI
Manufacturer
SyntheticMR AB
Date Cleared
2020-07-28

(43 days)

Product Code
LNH
Regulation Number
892.1000
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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 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.

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.

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 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 adjustment. 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.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the SyMRI device. It provides information about the device's indications for use but does not contain details about specific acceptance criteria, device performance studies, or the methodologies used to establish ground truth or conduct multi-reader studies.

Therefore, I cannot provide the requested information based solely on the provided text. The provided text is a regulatory clearance document, not a clinical study report or a detailed performance validation report.

To answer your questions accurately, I would need a clinical testing report or a similar technical document that details the device's validation studies.

Based on the provided text, I can only extract the following:

Device Name: SyMRI
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: Class II

Indications for Use:

  • Post-processing software medical device for visualization of the brain.
  • Analyzes input data from MR imaging systems.
  • Utilizes data from a multi-echo acquisition (MDME) to generate parametric maps of R1, R2 relaxation rates, and proton density (PD).
  • Can generate multiple image contrasts from the parametric maps.
  • Enables post-acquisition image contrast adjustment.
  • Indicated for head imaging.
  • 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.
  • 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).

I cannot answer the following questions from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not in the FDA clearance letter.
  2. Sample sized used for the test set and the data provenance: Not provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
  4. Adjudication method for the test set: Not provided.
  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: Not provided.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
  7. The type of ground truth used: Not explicitly stated (though it references "trained physician interpretation").
  8. The sample size for the training set: Not provided.
  9. How the ground truth for the training set was established: Not provided.

§ 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.