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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.

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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