Sourcerer is a software tool designed for neurologists and EEG technologists to visualize brain activity by integrating EEG data with MRI images. It helps localize sources of brain activity by projecting EEG signals onto an idealized head model, aiding in clinical diagnoses such as epilepsy evaluation.
Intended Use
The software is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 16 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an idealized head model and an idealized MRI image.
Technology
Sourcerer uses EEG and MRI-derived data with a client-server model. It employs the Finite Element Method for forward modeling of current flow through brain tissues and uses inverse algorithms including LORETA, sLORETA, and Multiple Sparse Priors (MSP) to estimate brain activity sources. Visualization is done using a web browser interface showing results on idealized head models.
Performance
Performance testing included algorithmic validation comparing HexaFEM forward modeling with analytical and Finite Difference Method results, showing consistency. Inverse methods demonstrated localization errors of about 7 mm for LORETA, exact results for sLORETA, and zero localization error for MSP. Clinical testing on epileptic patients showed performance equivalent to the predicate device GeoSource, with source localization accurately matching resected brain regions.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/29/2024
4 months - 2
FDA Approval
9/27/2024
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