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1. LVIS NeuroMatch Software is intended for the review, monitoring and analysis of electroencephalogram (EEG) recordings made by EEG devices using scalp electrodes and to aid neurologists in the assessment of EEG. The device is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information. 2. The Seizure Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients greater than or equal to 18 years old that may correspond to electrographic seizures, in order to assist qualified medical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the electrodes from the International Standard 10-20 placement. 3. The Spike Detection component of LVIS NeuroMatch is intended to mark previously acquired sections of adult EEG recordings from patients ≥18 years old that may correspond to spikes, in order to assist qualified medical practitioners in the assessment of EEG traces. LVIS NeuroMatch Spike Detection performance has not been assessed for intracranial recordings. 4. LVIS NeuroMatch includes the calculation and display of a set of quantitative measures intended to monitor and analyze EEG waveforms. These include Artifact Strength, Asymmetry Spectrogram, Autocorrelation Spectrogram, and Fast Fourier Transform (FFT) Spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. 5. LVIS NeuroMatch displays physiological signals such as electrocardiogram (ECG/EKG) if it is provided in the EEG recording. 6. The aEEG functionality included in LVIS NeuroMatch is intended to monitor the state of the brain. 7. LVIS NeuroMatch Artifact Reduction (AR) is intended to reduce muscle and eye movements, in EEG signals from the International Standard 10-20 placement. AR does not remove the entire artifact signal and is not effective for other types of artifacts. AR may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifacts, and any interpretation or diagnosis must be made with reference to the original waveforms. 8. LVIS NeuroMatch EEG source localization visualizes brain electrical activity on a 3D idealized head model. LVIS NeuroMatch source localization additionally calculates and displays summary trends based on source localization findings over time. 9. This device does not provide any diagnostic conclusion about the patient's condition to the user.

NeuroMatch is a cloud-based software as a medical device (SaMD) intended to review, monitor, display, and analyze previously acquired and/or near real-time electroencephalogram (EEG) data from patients greater than or equal to 18 years old. The device is not intended to substitute for real-time monitoring of EEG. The software includes advanced algorithms that perform artifact reduction, seizure detection, and spike detection. The subject device is identical to the NeuroMatch device cleared under K241390, with exception of the following additional features: 1. Source localization; 2. Source localization trends; Source localization and source localization trends are substantially equivalent to the Epilog PreOp (K172858). Apart from the proposed additional software changes and associated changes to the Indications for Use and labeling there are no changes to the intended use or to the software features that were previously cleared. Below is a description of the software functions that will be added to the cleared NeuroMatch Device. ### 1. Source Localization The NeuroMatch Source Localization visualization feature is used to visualize recorded EEG activity from the scalp in an idealized 3D model of the brain. The idealized brain model is based on template MR images. Each single sample of EEG-measured brain activity corresponds to a single point/pixel referred to as a source localization node (i.e., "node"). Together, the source localization nodes form a 3D cartesian grid where EEG signals with higher standardized current density are depicted in red and signals with lower standardized current density are depicted in blue. Source localization can be performed for any selected segment of the EEG data. The maximum and minimum of the source localization values are the absolute maximum and minimum values across the selected EEG signal, respectively. Users can also set an absolute threshold for the minimum value of the source localization outputs. ### 2. Source Localization Trends NeuroMatch provides three automatic source localization trends to assist physicians investigating the amplitude and the frequency of the signal of interest (e.g. seizure onset) at the source space. Two of the trends provide simple 3D views of the sources of the high amplitude / high frequency across the signal of interest. The third trend provides a similar 3D view of the high frequency source movement across time. - **Maximum Amplitude Projection (MAP):** This metric allows clinicians to readily determine which brain regions are active and have high amplitude source localization results. The metric is determined by iterating through each node within a specified analysis time window and outputting the maximum source localization amplitude at that node within the specified analysis time window. No value is reported for nodes which have not been identified as maximum at any time during the specified window. This metric can help show brain regions that have high amplitude during a seizure. - **Node Visit Frequency (NVF):** This metric is reported as the number of times that a node has been labeled as maximum over time. This metric can help clinicians identify which brain regions are frequently active during a seizure. - **Node Transition Frequency (NTF):** This metric allows clinicians to determine which brain regions are active in consecutive time frames over a selected time period. A node transition is defined as a transition from one maximum point to another over time, and the node transition frequency is calculated by iterating through all time points for a specified analysis window, counting the number of times a transition between two points occurs over that time, and then dividing it by the time window of analysis. This metric can help identify pairs of brain regions that are frequently active in sequential order.

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.

Sourcerer is an EEG source localization software that uses EEG and MRI-derived information to estimate and visualize cortex projections of human brain activity. Sourcerer is designed in a client-server model wherein the server components integrate directly with FLOW - BEL's software. Inverse source projections are computed on the server using EEG and MRI data from FLOW using the Electro-magnetic Inverse Module (EMIM API). The inverse results are interactively visualized in the Chrome browser running on the client computer using the Electro-magnetic Functional Anatomy Viewer (EMFAV).

The TRIUX™ neo non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortices in the brain when used in coniunction with evoked response stimulators. MEG is also used to noninvasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning. TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography. MEGreview™ is used for detection and localization of epileptic spontaneous brain activity. In addition, MEGreview™ may be used for localization of eloquent cortex, such as visual, auditory, somatosensory, and motor functions. Results interpreted by a trained clinician in conjunction with other imaging modalities can contribute to presurgical evaluation. MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.

TRIUX™ neo NM27000N (TRIUX™ neo below) is a magnetoencephalographic (MEG) device, designed to non-invasively detect and display biomagnetic signals produced by electrically active nerve tissue in the brain. This system enables diagnostic capabilities by providing information about the location of active nerve tissues relative to brain anatomy. It measures both MEG and electroencephalographic (EEG) signals, which are then recorded, displayed, and interpreted by trained clinicians to aid in neurosurgical planning and locating regions of epileptic activity. TRIUX™ neo employs 306 SQUID (Superconducting Quantum Interference Device) detectors to measure magnetic signals with minimal distortion, allowing for localization of brain activity. The detectors are housed in a cryogenic Dewar vessel, along with an internal helium recycler to maintain optimal operating conditions. The TRIUX™ neo svstem features a probe unit with a modular structure, a patient-support system with a couch and chair for various positioning needs, and an electronics setup housed outside the magnetically shielded room. The software component, MEGflow™ facilitates data acquisition, preprocessing, and analysis, and includes functionalities for clinical epilepsy workflows, MRI integration, and visualization tools. MEGreview™ is a software for off-line visualization, and localization of brain activity measured with magnetoencephalography (MEG) and, optionally, visualization of brain activity measured with scalp electroencephalography (EEG). MEGreview™ provides workflows for epilepsy focus localization and functional mapping including signal processing, source localization, integration with anatomical MRI and visualization of the results overlayed on anatomical information, as well as reporting and exporting the results. MEGreview™ is intended to be used with TRIUX™ neo or equivalent MEG devices.

The RICOH MEG non-invasively measures the magnetoencephalographic (MEG) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, and somatosensory activity in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epilentic activity within the brain. The localization information provided by the device may be used, in conjunction with other diagnostic data, as an aid in neurosurgical planning.

The RICOH MEG Analysis is an analysis software package used for processing and analyzing MEG data. It displays digitized MEG signals, EEG signals, topographic maps, and registered MRI images. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic MEGvision Software of Eagle Technology, Inc. (K040051). The RICOH MEG Analysis is designed to aid clinicians in the assessment of patient anatomy, physiology, electrophysiology and pathology and to visualize source localization of MEG signals.

EZTrack is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects with focal or multifocal epilepsy at least 3 years of age for the visualization of human brain from analysis of electroencephalographic (EEG) signals produced by electrically active tissue of the brain. EZTrack calculates and displays the Fragility Index, a quantitative index based on an analysis of spatiotemporal EEG patterns that is intended for interpretation by trained physicians to aid in the evaluation of patients with focal or multifocal epilepsy. The device does not provide any diagnostic conclusion about the patient's condition to the user and should be interpreted along with other clinical data, including the original EEG, medical imaging, and other standard neurological and neuropsychological assessments.

EZTrack is a web-based software-only device that allows visualization of human brain function based on the analysis of electroencephalographic (EEG) signals. The EZTrack algorithm produces a fragility score for each EEG recording node. The EZTrack fragility values are shown to correlate with regions that clinicians have annotated as seizure onset zones (SOZ) prior to resective surgery, and may be used in conjunction with other clinical data such as EEG, medial imaging, neuropsychological testing, and other neurologic assessments in order to aid in the evaluation of patients with focal or multifocal epilepsy. The device does not provide any diagnostic conclusion about the patient's condition. EZtrack displays the fragility of each EEG channel in a heatmap to aid in interpretation.

PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediativ 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 MR 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 uploaded by the user to the PreOp cloud environment. 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 the PreOp cloud environment.

GeoSource 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 idealized head model and an idealized MRI image.

GeoSource is an add-on software module to EGI's Net Station software and can only be used on EEG data generated by EGI hardware. It runs on a personal computer. It is used to approximate source localization of EEG signals and visualize those estimated locations. It uses the linear inverse methods LORETA, LAURA, and sLORETA and the sphere and Finite Difference forward head models.

The GridView software is indicated for use by qualified and trained medical personnel for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed.

The GridView software is indicated for use by qualified and trained medical personnel for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed.

The Elekta Neuromag® with MaxFilter 2.1 is intended for use as a magnetoencephalographic (MEG) device which non-invasively detects and displays biomagnetic signals produced by electrically active nerve tissue in the brain. When interpreted by a trained clinician, the data enhances the diagnostic capability by providing useful information about the location relative to brain anatomy of active nerve tissue responsible for critical brain functions. Elekta Neuromag® with MaxFilter™ non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

This premarket notification represents modifications made to our current product. The present device differs from the predicate device, K050035, Elekta Neuromag® with Maxwell Filter only in the following areas of functionality: Spatiotemporal interference elimination, Graphical user interface; and Offline averager. The modification also adds compatibility with internal active shielding, an interference removal method described in K081430. MaxFilter™ is intended to be used with Elekta Neuromag® MEG products in reducing measurement artifacts.

Elekta Neuromag® with active shielding non-invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic (EEG) signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed and may then be interpreted by trained physicians to help localize these active areas. The locations may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain when used in conjunction with evoked response averaging devices. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

This premarket notification represents modifications made to our current product. Internal active shielding has been added to enhance the signal to noise ratio. The internal active shielding system is a magnetic shielding technique intended to be an integrated, optional part of Elekta Neuromag® magnetoencephalograph. The internal active shielding system increases the dynamic range of the magnetometers. related external magnetic interferences, by internal feedback compensation that uses the sensor array of the biomagnetometer as a zero indicator and compensation coils placed inside the magnetically shielded room to deliver a cancellation field for attenuating the interference.