(149 days)
Not Found
No
The document describes standard signal processing and source localization techniques for MEG/EEG data. There is no mention of AI, ML, or deep learning in the device description, intended use, or performance studies. The localization methods described are based on established biophysical models (equivalent current dipole).
No
The device is described as a diagnostic tool used to localize active areas of the brain, such as epileptic activity or eloquent cortices, to aid in neurosurgical planning. It does not provide treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "helps localize these active areas" and is used to "noninvasively locate regions of epileptic activity within the brain." The "Device Description" also mentions that the system "enables diagnostic capabilities by providing information about the location of active nerve tissues relative to brain anatomy." These statements clearly indicate the device's role in diagnosing or aiding in the diagnosis of neurological conditions.
No
The device description clearly states that the TRIUX™ neo system includes hardware components such as SQUID detectors, a cryogenic Dewar vessel, a probe unit, and a patient-support system. While MEGreview™ is described as software, it is intended to be used with the TRIUX™ neo or equivalent MEG devices, which are hardware systems. Therefore, the overall device described is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TRIUX™ neo and MEGreview™ system non-invasively measures and analyzes signals produced by the brain itself (MEG and EEG). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to help localize active areas of the brain, identify locations of functional cortices, and locate regions of epileptic activity. This is done by analyzing the brain's electrical and magnetic activity directly, not by testing bodily fluids or tissues.
Therefore, the TRIUX™ neo and MEGreview™ system falls under the category of a non-invasive diagnostic imaging or measurement device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLX, OLY
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetoencephalography (MEG), Electroencephalography (EEG), MRI
Anatomical Site
Brain
Indicated Patient Age Range
All ages
Intended User / Care Setting
Trained physicians/clinicians. Not specified.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Clinical Investigations for TRIUX™ neo (MaxFilter™ software component):
- Sample Size: Twenty healthy adult (age 23 - 38, mean 30 years) and ten child (age 3 - 12, mean 7 years) volunteers for evoked response studies. Five pediatric epilepsy patients (age between 8 months and 15 years) for localized epileptic activity.
- Data Source: MEG recordings.
- Annotation Protocol: Volunteers were studied with two magnetoencephalographic (MEG) systems. Four recordings were done with both systems. 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 MEG recordings, subjects received interleaved auditory and somatosensory stimuli. Source localization results were compared to the localization obtained from recordings with stationary head position without MC as obtained using the predicate localization software. For epilepsy patients, data exhibiting focal or multifocal interictal epileptiform discharges (IEDs) were examined.
Verification of MEGreview™ localization accuracy:
- Sample Size: Not specified for number of phantom data or simulated signals.
- Data Source: Measured phantom data and simulated epileptiform MEG signals.
- Annotation Protocol: All dipole localizations were compared to the results from Xfit software in the predicate device. Simulated epileptiform signals were superposed with resting state brain activity.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Phantom testing:
- Study Type: Bench testing with phantom data.
- Sample Size: Not specified.
- Key Results: The effect of movement was clearly demonstrated in dipole localizations without MC, resulting in large errors. The combined tSSS+MC restored the dipole localization accuracies to a similar level as from corresponding phantom dipole sources when the phantom was not moved.
Clinical Investigations (MaxFilter™ software component):
- Study Type: Clinical investigation with healthy volunteers and epilepsy patients.
- Sample Size: 20 healthy adults, 10 children, 5 pediatric epilepsy patients.
- Key Results:
- 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 in localization of the resulting dipoles of less than 10 mm.
- Continuous head movements caused distortions of auditory evoked signals, but somatosensory responses were less affected.
- 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:
- Study Type: Bench testing with phantom data and simulated signals.
- Sample Size: Not specified.
- Key Results: The overall localization errors were very similar between MEGreview™ and Xfit (predicate's software). Both programs could localize phantom dipoles with less than 5 mm errors and with similar dipole amplitudes and statistical parameter values. Simulated epileptiform signals showed equivalent localization accuracy between MEGreview™ and Xfit. The results demonstrate that the ECD localization accuracy of MEGreview™ is on a level which is clinically valuable.
Summary:
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Localization accuracy: less than 10 mm difference compared to predicate for evoked responses with tSSS+MC.
- Localization accuracy: less than 5 mm error for phantom dipoles.
- Localization of irritative zone equivalent to predicate for pediatric epilepsy patients, with head movements up to 25 mm.
- Spatial accuracy: equal or better than ±5 mm with known source locations in phantom measurement.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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"
1
(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
3
Indications for Use
Submission Number (if known)
Device Name
TRIUX™ neo; MEGreview™
Indications for Use (Describe)
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.
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 MaxFilter | ||
| Elekta Neuromag Oy | OLX, OLY | ✓ |
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DEVICE DESCRIPTION
TRIUX™ neo
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™
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.
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
6
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 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.
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 K091393
Elekta Neuromag® with
MaxFilter 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 entire
acquisition process (e.g., patient
creation, digitization, acquisition,
saving data, etc.) | No workflow |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Support for
interference
suppression | Yes, SSS-technology for
suppression of environment and
near-by interference (tSSS) and
motion disturbances | Yes, SSS-technology for
suppression of environment and
near-by interference (tSSS) |
| Data
compensation if
patient moves | Yes, SSS-based head movement
compensation | No movement compensation |
| Data storage | Patient-centric database that allows
the user to store and access
MEG/EEG scans, together with
relevant metadata. This includes
raw and preprocessed scans, video
MEG, anatomical scans (MRI) and
corresponding analysis results. | File-based |
| API | MEGflowTM scan acquisition
system and data management server
has been developed to support
"plug-in" mapping applications and
REST-API interface layer for data
acquisition, scan control, database
access, and user authentication. | No API |
| Auxiliary
Channels | - 12 auxiliary analog inputs
- 12 bipolar analog input channels
for physiological signals | - 8 auxiliary analog inputs - 4 bipolar analog input channels
for physiological signals |
| Attribute | Subject device MEGreviewTM | Predicate device K091393
Elekta Neuromag® with
MaxFilter 2.1 |
| Operating system | Windows | Unix |
| Data access | Patient-centric | File-based |
| GUI | Workflow-driven | Several separate tools, no
workflow |
| Availability of
patient video | Synchronized video with data | No video available |
| Method of
Calculation /
Forward head
model (i.e.,
idealized v.
individual head
model) | Spherical conductor model for
idealized head shapes. | Spherical conductor model for
idealized head shapes. Boundary
element method (BEM) for
individual head shapes. |
| Source Estimate
Methods / Inverse
head model | Equivalent Current Dipole (ECD)
for clinical analysis. Single-dipole
time varying source estimates. | Equivalent Current Dipole (ECD)
for clinical analysis. Single- and
multi-dipole time varying source
estimates. |
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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
9
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.