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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.

Device Description

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the TRIUX™ neo and MEGreview™ devices, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Device Performance (Reported Outcome)
Preserve signal quality for data analysis	Successfully preserved signal quality for data analysis (clinical investigations)
Reduce localization error	Reduced localization error (clinical investigations)
Localization error of evoked responses and epileptiform events < 10 mm (vs. predicate without MC)	Mean difference in localization of resulting dipoles < 10 mm (clinical investigations for somatosensory and temporary auditory responses)
Localization accuracy of equivalent current dipoles (ECD) < 5 mm (phantom)	Localized phantom dipoles with less than 5 mm errors (MEGreview™ localization accuracy verification)
Equivalent localization accuracy to predicate (Xfit software) for phantom and simulated epileptiform signals	Overall localization errors very similar between MEGreview™ and Xfit (MEGreview™ localization accuracy verification)
Equivalence in localization of irritative zone in pediatric epilepsy patients (with motion vs. little-to-no motion)	Equivalent localization of irritative zone obtained when applying MC to temporary head movements (less than 25 mm) compared to little-to-no motion (less than 5 mm)
Fulfills essential performance (software and bench testing)	Demonstrated that the subject device fulfills the essential performance (software verification and bench testing)
Spatial accuracy equal or better than ±5 mm with known source locations (phantom)	Spatial accuracy equal or better than ±5 mm with known source locations in phantom measurement (software verification and bench testing)

2. Sample Size Used for the Test Set and Data Provenance

Clinical Investigation (Evoked Responses):
- Sample Size: 20 healthy adult volunteers (age 23-38, mean 30 years) and 10 child volunteers (age 3-12, mean 7 years).
- Data Provenance: Not explicitly stated, but implies prospective collection for the study. No country of origin is mentioned.
Clinical Investigation (Pediatric Epilepsy):
- Sample Size: 5 pediatric epilepsy patients (age between 8 months and 15 years).
- Data Provenance: Retrospective analysis of existing MEG recordings from pediatric epilepsy patients showing interictal epileptiform discharges (IEDs). Not explicitly stated, but implies retrospective. No country of origin is mentioned.
Phantom Testing (Test Set):
- Sample Size: Data generated from 8 artificial dipole sources, recorded with various movements.
- Data Provenance: Prospectively generated phantom data.
MEGreview™ Localization Accuracy (Test Set):
- Sample Size: Measured phantom data (number of dipoles not specified but likely related to the 8 artificial dipoles from phantom testing) and simulated epileptiform MEG signals (number not specified).
- Data Provenance: Phantom data (prospectively generated) and simulated data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, given the nature of MEG studies and the comparison to "localization obtained from recordings with stationary head position without MC as obtained using the predicate localization software," it implies that the "ground truth" for the clinical studies was derived from established clinical practice with the predicate device or a clinical consensus based on the predicate. For phantom studies, the ground truth is the "exactly known dipole positions and amplitudes."

4. Adjudication Method for the Test Set

The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). The ground truth for the clinical studies appears to be based on the localization results from the predicate device with stationary head positions, or from known positions for phantom studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

No MRMC study was performed involving human readers and AI assistance. The studies focused on the performance of the device itself, particularly its motion compensation capabilities, and direct comparison of its localization accuracy against a predicate device's software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?

Yes, the studies are primarily standalone performance assessments of the TRIUX™ neo hardware and the MEGreview™ software.

TRIUX™ neo: Its performance was evaluated in terms of its ability to acquire and process MEG/EEG signals, including interference suppression and motion compensation, and then compared to the predicate's outcomes.
MEGreview™: Its localization accuracy was directly compared to the predicate's Xfit software using phantom and simulated data.
The clinical investigations evaluated the impact of the device's motion compensation functionality on the localization results, not on human reader performance with or without the device. The interpretation of the signals is still done by "trained clinicians."

7. The Type of Ground Truth Used

Clinical Investigations (Evoked Responses & Pediatric Epilepsy): The ground truth for comparison was established by:
- Localization obtained from recordings with stationary head position without motion compensation (MC) using the predicate localization software. This can be considered as a clinical reference standard based on established methods.
Phantom Testing & MEGreview™ Localization Accuracy:
- Exactly known dipole positions and amplitudes (for phantom data). This is an objective, engineered ground truth.
- Results from the Xfit software in the predicate device (for both phantom and simulated epileptiform signals). This serves as a reference standard for comparison to demonstrate equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate training set size for the algorithms within TRIUX™ neo or MEGreview™. The description focuses on verification and validation testing using specific test sets. It's possible that the algorithms were developed and trained using internal datasets not detailed in this 510(k) summary, or are model-based and don't rely on traditional "training sets" in the machine learning sense. The information provided is primarily related to the validation of the final product.

9. How the Ground Truth for the Training Set Was Established

As no explicit training set is detailed, the method for establishing its ground truth is also not described.

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