(352 days)
SyMRI is a post-processing software medical device intended for use in visualization of soft tissue. 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 soft tissue. 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.
The provided FDA 510(k) clearance letter and Indications for Use document do not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the technical documentation submitted with the 510(k) application, such as validation studies, performance testing reports, and clinical trial summaries, which are not included in the provided text.
Specifically, the document focuses on the regulatory clearance process rather than the technical details of the device's performance validation. Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This would be in a performance study report.
- Sample size used for the test set and the data provenance: This would be detailed in the methodology section of a validation study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is specific to how a test set's ground truth was determined in a clinical or validation study.
- Adjudication method for the test set: Similarly, this relates to expert review processes in a study.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This would be a specific study design and its results.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This pertains to the type of performance evaluation conducted.
- The type of ground truth used: This would be explicitly stated in the study's methods.
- The sample size for the training set: This refers to the development phase of the algorithm, not typically found in the regulatory clearance document.
- How the ground truth for the training set was established: This is also part of the algorithm development documentation.
The provided text only states that SyMRI "analyzes input data from MR imaging systems" to "generate parametric maps of R1, R2 relaxation rates, and proton density (PD)" and "can generate multiple image contrasts from the parametric maps." It also mentions its use for "automatic labeling, visualization and volumetric quantification of segmentable brain tissues from a set of MR images." It emphasizes that "SyMRI should always be used in combination with at least one other, conventional MR acquisition (e.g. T2-FLAIR)" and that "SyMRI images can provide information useful in determining diagnosis" when "interpreted by a trained physician."
These are descriptions of the device's functions and intended use, not performance metrics, acceptance criteria, or study details.
To answer your request, I would need access to the actual validation studies or performance testing reports submitted by SyntheticMR AB for their SyMRI device, which are not present in the provided FDA communication.
§ 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.