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BrainSpec Core™ software is a post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data to support the diagnostic process. BrainSpec Core™ software includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity.

A fit algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.

The post-processing fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of pre-defined results such as spectral maps, and metabolite images is provided. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results. and synchronized display.

The BrainSpec Core™ Software provides analysis of magnetic resonance spectroscopy (MRS) data. MRS is a technology available on standard MRI scanners that detects the presence of various chemical compounds in a volume of tissue. The software provides these analyses:

• Estimation of the concentrations of various metabolites present in the acquired . data, presented to the user as ratios concentrations (when water reference files is available). These metabolites include N-acetylaspartate (NAA). choline (Cho), creatine (Cr), myoinositol (mlns), and glutamine/glutamate (Glx), DL-lactic acid (Lac), and 2-hydroxygluturate (2HG-ng) expressed as a ratio.
• Spatial registration of the acquired volume with anatomical MR images, such that . the spectroscopy volume is overlaid on an anatomical image in the same plane.
• . Visual display of the data's spectrum (a representation of the data in which peaks correspond to specific compounds)
• . Ratio measurements of each metabolite may be compared to reference percentile data if a reference interval has been established.

BrainSpec Core™ Software supports 3.0 Tesla scanners manufactured by Philips, Siemens, and GE with predefined pulse sequences: PRESS short echo (TE=25-45ms), PRESS (long echo (TE=135-144) and PRESS optimized for 2HG (TE=97).

The software provides a user interface over the web. The user must access the software via the Google Chrome web browser on any operating system, provided the computer has a reliable internet connection. The uploaded data are processed with several applications. Both the web application and the data processing software read and write files and data in Google Cloud Platform resources.

The reference intervals specific for adults indicating how user-uploaded data compares to a range of typical values for a given metabolite ratio are aggregated from decades of data from adult reference subjects with no known history of neurological or major psychiatric disorders. The reference intervals are specific to the acquisition parameters and indicated adult brain region of the uploaded data, and were determined from research studies employing those matching parameters and brain regions. Reference intervals are only displayed when the relevant acquisition parameters are matched.

The provided document is a 510(k) Summary for the BrainSpec Core™ Software. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria, a specific study proving the device meets those criteria, or the methodology and results of such a study in the format requested.

Therefore, many of the requested details, such as the specific acceptance criteria values, the reported device performance compared to those criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC study details, cannot be extracted from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or quantitative reported device performance values. It generally discusses the device's functionality and its comparison to a predicate device without defining specific numerical thresholds for acceptance.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in the document.
• Data Provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified 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:

Not applicable. The document does not describe an MRMC comparative effectiveness study or any human-in-the-loop performance evaluation. The device is a "post-processing application to analyze and evaluate MR (magnetic resonance) spectroscopy data" meant to "support the diagnostic process" and its results are to be "interpreted by a trained physician."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The document lists "Valid clinical association" and "Software testing, including unit testing, and verification testing" under "Performance Data," indicating some form of standalone evaluation. However, details of the performance metrics or the specific study for standalone performance are not provided. The phrase "A fit algorithm reduces the need for manual data processing and offers the user reproducible evaluation results" suggests confidence in the algorithm's automated output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document mentions that "Reference intervals specific for adults indicating how user-uploaded data compares to a range of typical values for a given metabolite ratio are aggregated from decades of data from adult reference subjects with no known history of neurological or major psychiatric disorders." This suggests that the reference intervals, which aid in interpreting the device's output, are based on aggregated historical data from a healthy population. For the device's core functionality (quantification of metabolites), it states, "Values of metabolite peaks are calculated based on a linear combination" model, which is an algorithmic approach rather than relying on an external ground truth like pathology at the time of calculation.

8. The sample size for the training set:

Not specified in the document.

9. How the ground truth for the training set was established:

Not specified in the document. For the "reference intervals," it states they "were determined from research studies employing those matching parameters and brain regions," but it does not detail how the ground truth for the underlying algorithm's training (if any was used for the "fit algorithm") was established.

Summary of what is available from the document:

The BrainSpec Core™ Software is a post-processing application for MR spectroscopy data, quantifying metabolites like NAA, Cho, Cr, mIns, Glx, Lac, and 2HG. It uses a "fit algorithm" based on a linear combination model for metabolite quantification. The software also provides reference intervals for adult brain regions, aggregated from decades of data from healthy subjects with no known neurological or psychiatric disorders, established according to CLSI guidelines and defined by research studies. The document does not offer a detailed performance study with specific acceptance criteria, sample sizes, expert involvement, or adjudication methods. It primarily focuses on demonstrating substantial equivalence to its predicate device (Siemens Syngo K120315) based on intended use, operating principles, and technological characteristics.

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