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.

Summary

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May 15, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Megin Oy % Charles Neitzel Principal Consultant ROM+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146

Re: K233985

Trade/Device Name: TRIUX™ neo; MEGreview™ Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX, OLY Dated: April 15, 2024 Received: April 15, 2024

Dear Charles Neitzel:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Jay R. Gupta -S

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K233985

Device Name

TRIUX™ neo; MEGreview™

Indications for Use (Describe)

TRIUX™ neo may be used for patients of all ages as appropriate for magnetoencephalography.

MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

DATE PREPARED

May 15, 2024

MANUFACTURER

Megin Oy Keilasatama 5 02150 Espoo, Finland Telephone: +358 9 756 2400 Laura Vanonen QA&RA Manager

REPRESENTATIVE/CONSULTANT

Charles Neitzel RQM+ 2790 Mosside Blvd, Suite 800 Monroeville, PA 15146 Telephone: (262) 716-3243 Email: cneitzel@rqmplus.com

DEVICE INFORMATION

Device trade name, or proprietary name: TRIUX™ neo and MEGreview™ ●
Device common name: Magnetoencephalograph ●
Classification: II ●
. Classification Name: Electroencephalograph
Regulation number: 21 CFR 882.1400
Primary Product Code: OLX ●
Secondary Product Code: OLY ●
Panel: Neurology ●

PREDICATE DEVICE IDENTIFICATION

TRIUX™ neo and MEGreview™ are substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Product Codes	Primary Predicate
K091393	Elekta Neuromag with MaxFilterElekta Neuromag Oy	OLX, OLY	✓

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DEVICE DESCRIPTION

TRIUX™ neo

MEGreview™

MEGreview™ is intended to be used with TRIUX™ neo or equivalent MEG devices.

INDICATIONS FOR USE

TRIUX™ neo

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 cortex in the brain when used in conjunction with evoked response stimulators. MEG is also used to non-invasively locate regions of epileptic activity

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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™

MEGreview™ is intended for patients of all ages as appropriate for magnetoencephalography.

COMPARISON OF INDICATIONS FOR USE

TRIUX™ neo has identical Indications for use as the primary predicate Elekta Neuromag® with MaxFilter 2.1.

MEGreview™ has similar Indications for use as the primary predicate Elekta Neuromag® with MaxFilter 2.1. The predicate device is the whole MEG system including hardware and software for both data acquisition and analysis, and MEGreview™ is the analysis software only. While worded differently, the Indications for use for MEGreview™ is the same as for the analysis software part of the predicate device; source localization of active brain areas (epileptic spontaneous activity or eloquent cortex).

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices utilize the same principle of operation, which is to measure MEG signals which are interpreted by a trained clinician in conjunction with other imaging data to contribute to presurgical evaluation. 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.

Attribute	Subject device TRIUX™ neo	Predicate device K091393Elekta Neuromag® withMaxFilter 2.1
Operating system (user)	Windows	Unix
Digitization hardware	Polhemus FASTRAK and upgraded digitization chair	Polhemus FASTRAK and digitization chair
Patient Position	Supine, reclined and upright	Supine and reclined
Synchronized video recording during the scan	Yes	No

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GUI	Workflow-driven for entireacquisition process (e.g., patientcreation, digitization, acquisition,saving data, etc.)	No workflow
Support forinterferencesuppression	Yes, SSS-technology forsuppression of environment andnear-by interference (tSSS) andmotion disturbances	Yes, SSS-technology forsuppression of environment andnear-by interference (tSSS)
Datacompensation ifpatient moves	Yes, SSS-based head movementcompensation	No movement compensation
Data storage	Patient-centric database that allowsthe user to store and accessMEG/EEG scans, together withrelevant metadata. This includesraw and preprocessed scans, videoMEG, anatomical scans (MRI) andcorresponding analysis results.	File-based
API	MEGflowTM scan acquisitionsystem and data management serverhas been developed to support"plug-in" mapping applications andREST-API interface layer for dataacquisition, scan control, databaseaccess, and user authentication.	No API
AuxiliaryChannels	- 12 auxiliary analog inputs- 12 bipolar analog input channelsfor physiological signals	- 8 auxiliary analog inputs- 4 bipolar analog input channelsfor physiological signals
Attribute	Subject device MEGreviewTM	Predicate device K091393Elekta Neuromag® withMaxFilter 2.1
Operating system	Windows	Unix
Data access	Patient-centric	File-based
GUI	Workflow-driven	Several separate tools, noworkflow
Availability ofpatient video	Synchronized video with data	No video available
Method ofCalculation /Forward headmodel (i.e.,idealized v.individual headmodel)	Spherical conductor model foridealized head shapes.	Spherical conductor model foridealized head shapes. Boundaryelement method (BEM) forindividual head shapes.
Source EstimateMethods / Inversehead model	Equivalent Current Dipole (ECD)for clinical analysis. Single-dipoletime varying source estimates.	Equivalent Current Dipole (ECD)for clinical analysis. Single- andmulti-dipole time varying sourceestimates.

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SUMMARY OF TESTING

The following tests were performed to demonstrate safety based on current industry standards:

TRIUX™ neo

General requirements for basic safety and essential performance of medical ● electrical equipment per IEC 60601-1
Electromagnetic compatibility requirements and tests per IEC 60601-1-2 ●
. Software verification per IEC 62304 requirements - including the verification of MaxFilter
. Verification and Validation of the system and subsystem requirements

MEGreview™M

Software verification per IEC 62304 ●
Acceptance testing and system verification .
Verification of MEGreview™ Localization Accuracy (see below)

Phantom testing

Phantom test data were utilized in validation studies of the head movement compensation (MC) function. Signals generated by eight artificial dipole sources (one by one) in a spherical phantom were recorded with continuous rotations around the Z-axis, or temporary movements by doing a rotation and translation repeated twice during a recording. The data were processed twice, first with the temporal Signal Space Separation (tSSS) method for interference suppression, and second time with combined tSSS and MC. A single equivalent current dipole (ECD) source in a spherical head model was applied for the source localization and the results were compared to exactly known dipole positions and amplitudes. The effect of the movement was clearly demonstrated in the dipole localizations without MC, resulting in large errors of dipole locations and amplitudes. The combined tSSS+MC restored the dipole localization accuracies to a similar level as from the corresponding phantom dipole sources when the phantom was not moved.

Clinical Investigations

A clinical investigation was performed with MaxFilter™ software in processing brain signals in evoked response studies. Twenty healthy adult (age 23 - 38, mean 30 years) and ten child (age 3 - 12, mean 7 years) volunteers were studied with two magnetoencephalographic (MEG) systems. Four recordings were done with both systems and the subjects were asked to: keep a stationary head position, change the head position twice during the recording, move the head continuously, and move the head and mouth when two magnetized pieces were attached to the scalp. During the MEG recordings the subjects received interleaved auditory and somatosensory stimuli. The source localization results were compared to the localization obtained from recordings with stationary head position without MC as obtained using the predicate localization software. In all trials with somatosensory responses and in temporary movements with auditory responses, the combined tSSS+MC yielded similar results to the predicate, as indicated by mean difference

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in localization of the resulting dipoles of less than 10 mm. However, continuous head movements caused distortions of auditory evoked signals due to strong background activation of the motor cortex and muscles moving the head. Still, the somatosensory responses in these trials were much less affected than the auditory responses. The results show that evoked responses obtained after processing data with MaxFilter™ can be regarded as equivalent with those obtained with the predicate device, based on the acceptance criteria listed above. Another clinical investigation was carried out by analyzing MEG recordings from five pediatric epilepsy patients (age between 8 months and 15 years). Effects of movement were examined by studying MEG data exhibiting focal or multifocal interictal epileptiform discharges (IEDs). The results show that compensation of temporary head movements can provide localization of the irritative zone equivalent to that obtained when patients exhibit little-to-no motion. The findings demonstrate that the application of MC to pediatric MEG recordings containing variable degrees of spontaneous, temporary head movements (less than 25 mm head movement) can provide localization of the irritative zone equivalent to that obtained when patients exhibit little-to-no motion (less than 5 mm head movement).

Verification of MEGreview™ localization accuracy

Measured phantom data and simulated epileptiform MEG signals were utilized for the verification of accuracy in MEGreview™M localization of equivalent current dipoles (ECD). All dipole localizations were compared to the results from Xfit software in the predicate device. The overall localization errors were very similar between MEGreview™ and Xfit. Both programs could localize phantom dipoles with less than 5 mm errors and with similar dipole amplitudes and statistical parameter values. Simulated epileptiform signals were superposed with resting state brain activity, and the localization accuracy was found to be equivalent between MEGreview™ and Xfit. The results demonstrate that the ECD localization accuracy of MEGreview™ is on a level which is clinically valuable.

Summarv

All software verification testing and bench testing have demonstrated that the subject device fulfills the essential performance, and the spatial accuracy is equal or better than ±5 mm with known source locations in phantom measurement.

Clinical investigations have demonstrated that the subject device enables successful localization of evoked responses and epileptiform events in presence of temporary head movements without compromising the dipole quality statistics or signal-to-noise ratio, and the localization of events is equivalent to the localization with predicate device.

Together, these clinical studies and technical evaluations suggest that in the case of limited head movement during a patient measurement compensation functionality, particularly when combined with spatiotemporal signal space separation, preserves the signal quality for data analysis and reduces the localization error.

The results of these tests indicate that TRIUX™ neo NM27000N and MEGreview™ are substantially equivalent to the predicate device K091393.

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CONCLUSION

Based on the testing performed, including software testing and non-clinical performance bench testing, it can be concluded that TRIUX™ neo NM27000N and MEGreview™ are substantially equivalent to the predicate device. TRIUX™ neo NM27000N and MEGreview™ together have the same intended use and similar technological characteristics as the predicate device.

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).