(56 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-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).
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.
This FDA 510(k) clearance letter for the SyMRI device ([K191036](https://510k.innolitics.com/search/K191036)) does not contain the detailed information necessary to answer all the questions about acceptance criteria and the study that proves the device meets them. The document primarily confirms the substantial equivalence of SyMRI to a predicate device and outlines regulatory compliance. It does not include specific performance data or study methodology.
Therefore, many sections below will be marked as "Not provided in the document."
Here's an attempt to answer the questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is Not provided in the document. FDA 510(k) letters typically do not contain the detailed performance specifications or the results of the studies. They acknowledge that such studies were performed to demonstrate substantial equivalence but do not present the raw data or acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is Not provided in the document.
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 provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is Not provided in the 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
This information is Not provided in the document. The Indications for Use state, "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)." This suggests a human-in-the-loop scenario, but no MRMC study or effect size is detailed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Indications for Use imply that SyMRI is not a standalone device for diagnosis, as it "should always be used in combination with at least one other, conventional MR acquisition" and its images are useful "When interpreted by a trained physician". Therefore, a standalone performance study is unlikely to be the primary basis for its clearance for diagnostic purposes. However, the document does not explicitly state whether a standalone study was performed for other aspects (e.g., image generation or volumetric quantification accuracy).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is Not provided in the document.
8. The sample size for the training set
This information is Not provided in the document.
9. How the ground truth for the training set was established
This information is Not provided in the document.
§ 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.