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PreOp V3 is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.

PreOp is medical device software that combines EEG data and MRI images to visualize recorded EEG activity in 3D in the brain. PreOp can be subdivided in 3 main modules: 3D Electrical Source Imaging (i.e. 3D ESI), Report generation and Viewer generation. The device's input is the MRI and EEG data that are provided by means of Persyst software. The output of the device is a report containing the results of the visualization and the ability to evaluate the results in 3D using the 3D viewer. The user can access the output through Persyst software.

The subject device, PreOp V3, incorporates technological enhancements compared to the predicate device PreOp V1 (K172858) while maintaining the same intended use, patient population, and core functional principles. PreOp V3 includes integration with the Persyst EEG Review and Analysis Software, allowing clinical users to access PreOp functionality directly within the Persyst interface, whereas PreOp V1 required operators to access the system through a separate cloud-based workflow. PreOp V3 also standardizes the anatomical workflow by supporting both an idealized (average) MRI model and individualized, patient-specific MRI data, whereas PreOp V1 supported only individualized MRI. PreOp V3 automates multiple functions that were previously performed manually in the predicate device, including EEG data preprocessing, spike detection, MRI segmentation, and clustering, thereby improving workflow efficiency without altering user control of final review steps. The spike clustering algorithms in PreOp V3 is enhanced to incorporate morphology and topography-based features, supporting improved precision of spike classification.

PreOp V3 also introduces a modernized, modular, containerized software architecture that replaces the monolithic design of PreOp V1. This updated architecture uses cloud-native microservices, enabling improved scalability, maintainability, and system performance, particularly when handling larger datasets. Additionally, PreOp V3 includes 3D visualization capabilities for head models and electrode positioning, improved temporal and spatial accuracy of source estimation, and refined reporting features with automated quality control checks.

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