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510(k) Data Aggregation
K Number
K230856Device Name
BrainSpec Core Software
Manufacturer
Date Cleared
2023-11-14
(230 days)
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
BrainSpec, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
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.
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