The NeuroField Analysis Suite is to be used by qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).

Device Description

The NeuroField Analysis Suite is a Normalizing Quantitative Electroencephalograph (QEEG) Software that can (1) execute EEG analysis and (2) conduct ERP test and ERP analysis. The NeuroField Analysis Suite is Software as a Medical Device (SaMD). The NeuroField Analysis Suite consists of two modules, the NF EEG Analysis Module and the NF ERP Module. The NF EEG Analysis Module is a separate analysis module that integrates with the Q21 EEG system by adding "Analysis", "Report", and "Tools" menu items and toolbars. It performs real-time and offline analysis functions and displays analysis results in separate windows in the UI, which can be accessed via the "Analysis" and "Reports" menu items. The NF ERP Module is a separate evoked response potential (ERP) module that can control and get data from the Q21 EEG system and performs typical ERP functions like stimulus presentation, EEG epoching, epoch averaging, reaction time, and ERP display. The NF ERP Module is a separate stand-alone application.

AI/ML Overview

The NeuroField Analysis Suite, comprising the NF EEG Analysis Module and the NF ERP Module, was evaluated for performance. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document doesn't explicitly state acceptance criteria in terms of numerical performance metrics (e.g., specific accuracy, sensitivity, specificity values). Instead, substantial equivalence is claimed based on comparable functionality and performance to predicate devices. The "performance" reported reflects this comparative approach.

Feature Category	Acceptance Criteria (Implied from Predicate Comparison)	Reported Device Performance
NF EEG Analysis Module (vs. NeuroGuide Analysis System)
EEG Analysis Functionality	Comparable re-montaging, filtering, event markers, and data analysis modes (marker-based or whole data).	Performs re-montaging, filtering, adding event markers, and analysis based upon markers or whole data.
Z-Score Generation	Comparable generation of Z-Scores for absolute and relative power of EEG bands/frequencies.	Generates Z-Scores for absolute power and relative power of EEG bands or individual frequencies.
Visualization	Comparable generation of head maps and FFT spectra with equivalent frequency resolution.	Generates head maps and FFT spectra, and with equivalent frequency resolution (0.5 Hz).
Reporting	Comparable tabular export and automated report generation.	Provides for tabular export and automated report generation.
Inverse Solution (LORETA)	Comparable calculation of inverse solution (Key Institute 2394 LORETA model) and generation of current densities/powers of ROIs using Brodmann Atlas.	Can calculate the inverse solution (using the standard LORETA Key Institute 2394 LORETA model) and generate the current densities and powers of the ROIs (Region of Interest) over the cortex using the Brodmann Atlas.
Supported File Formats	Comparable ability to read standard EDF and EDF+ files.	Reads standard EDF and EDF+ files, additionally supports XDF.
Signal/Spectrum Comparison	Comparable signals on EEG Plot and comparable spectrum/sidelobes for real and simulated data.	Shows comparable signals on the EEG Plot for the same EDF file as Neuroguide. Spectrum and sidelobes for real and simulated data are comparable.
Z-Score Comparison	Comparable Z-Scores for real and simulated data.	Shows comparable Z-Scores.
Headmap Topography	Comparable topographies over standard EEG bands.	Visualization of headmaps shows comparable topographies over the standard EEG bands.
NF ERP Module (vs. eVox System)
Averaged ERP Graphs	Comparable generation of averaged ERP graphs, allowing user to measure latency and magnitude.	Generates averaged ERP graphs for EEG channels, allowing user to measure latency and magnitude.
Session Length	Comparable customizable session length.	Allows for customizable session length.
Oddball Paradigm	Comparable application of auditory and visual oddball paradigms.	Applies auditory and visual oddball paradigm variations.
Parameter Settings	Comparable ability to set parameters for visual and auditory oddball paradigm.	Allows the user to set parameters for the visual and auditory oddball paradigm. More user-definable parameters than the predicate (e.g., visual filtering, oddball period, Go probability, customizable audio/visual stims).
Mathematical Correctness	Mathematically correct generated averaged ERPs.	Demonstrated mathematically correct generated averaged ERPs through mathematical validation.
ERP Component Elicitation	Elicitation of correct ERP components.	Analysis of real data shows it can elicit correct ERP components.
Stimulus Reliability	Reliable generated stimulus.	Confirmed via analysis of real data.
Test Reliability	Confirmed test reliability (split-half reliability).	Split-half reliability measure confirms test reliability.

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

NF EEG Analysis Module: The document states that "Comparative performance evaluations showed that the same EDF file, loaded to NF-EEG and Neuroguide shows comparable signals on the EEG Plot." It also mentions "real and simulated data" for spectrum and sidelobe calculations. No specific sample size (number of EDF files or simulated data instances) is provided.
- Data Provenance: Not explicitly stated, but the use of "real and simulated data" suggests a mix. "Same EDF file" implies existing data, which could be retrospective.
NF ERP Module:
- "Mathematical validation of NF-ERP was performed." - No specific sample size mentioned, as this is a theoretical assessment.
- "Analysis of real data shows that the NF-ERP can elicit correct ERP components, the generated stimulus is reliable, and the split-half reliability measure confirms test reliability." - No specific sample size (number of cases/patients) is provided for this "real data" analysis.
- Data Provenance: "Real data" is used, but country of origin or whether it's retrospective/prospective is not specified.

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

The document does not mention the use of experts to establish a "ground truth" for the comparative performance evaluations of either the EEG or ERP modules. The comparison is primarily against the output of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no external "ground truth" established by experts or adjudication process is described for the test set. The comparison is directly between the outputs of the NeuroField Analysis Suite and the predicate devices (Neuroguide or eVox).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI vs. without AI assistance was not conducted or described in this document. The study focuses on the standalone performance and comparison to predicate devices, not human-in-the-loop performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a standalone performance evaluation was done for both modules.

NF EEG Analysis Module: Directly compared its outputs (EEG plots, spectrums, sidelobes, Z-scores, headmaps) against those of the Neuroguide Analysis System.
NF ERP Module: Underwent mathematical validation to confirm the correctness of averaged ERPs and analysis of real data to demonstrate correct ERP component elicitation, stimulus reliability, and test reliability using split-half reliability.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations is implicitly the output or established functionality of the predicate devices (Neuroguide for EEG and eVox for ERP). For the NF ERP module, mathematical correctness and consistency with known physiological responses (correct ERP components, reliable stimulus) served as the "ground truth" for its internal validation. There's no mention of pathology, outcomes data, or external expert consensus as a ground truth.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This suggests that the NeuroField Analysis Suite, as a QEEG and ERP analysis software, likely relies on established algorithms and mathematical models rather than machine learning models that require extensive training data.

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

Not applicable, as no training set or machine learning model is described. The device appears to be based on deterministic algorithms for signal processing and statistical evaluation of EEG/ERP data.

Summary

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September 20, 2024

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NeuroField Inc. % Tom Renner Quality, Efficiency & Regulatory Affairs Consultant Vision28 915 SW Rimrock Way Ste 201 Pmb 402 Redmond, Oregon 97756

Re: K240420

Trade/Device Name: NeuroField Analysis Suite Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU, GWJ Dated: February 13, 2024 Received: February 13, 2024

Dear Tom Renner:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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,

Image /page/2/Picture/3 description: The image shows the text "Patrick Antkowiak -S" to the right of the letters "FDA". The letters "FDA" are in a light blue color. The text "Patrick Antkowiak -S" is in black.

for 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

510(k) Number (if known) K240420

Device Name NeuroField Analysis Suite

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Research Use (Per 21 CFR 201.26(a) and (b)) Over-The-Counter Use (21 CFR 201.66)	Research Use (Per 21 CFR 201.26(a) and (b))	Over-The-Counter Use (21 CFR 201.66)
Research Use (Per 21 CFR 201.26(a) and (b))
Over-The-Counter Use (21 CFR 201.66)

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Contact Details

Applicant Name:	NeuroField Inc.
	1836 State Street
	Santa Barbara, CA 93101
Contact Name:	Tom Renner
	Quality, Efficiency & Regulatory Affairs Consultant
	Vision28
	tom@vision28.com
	541 359 5939
Date Prepared:	September 19, 2023

Device Name

Trade Name:	NeuroField Analysis Suite
Product Code:	OLU, GWJ
Common and Classification Name:	Electroencephalograph
Classification Regulation:	21 CFR 882.1400
Product Class:	Class II

Legally Marketed Predicate Device

510(k)	Product Code	Trade Name	Applicant
K041263	OLU	NeuroGuideAnalysis System	Applied Neuroscience, Inc.228 176th Terrace DriveSt. Petersburg, Florida 33708

Legally Marketed Secondary Predicate Device

510(k)	Product Code	Trade Name	Applicant
K171781	GWJ	eVox System	Evoke Neuroscience, Inc.200 Valencia Dr. Suite 109Jacksonville, North Carolina 28546

Device Description

I. Overview

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II. Major Components

The NeuroField Analysis Suite consists of two modules, the NF EEG Analysis Module and the NF ERP Module.

The NF EEG Analysis Module is a separate analysis module that integrates with the Q21 EEG system by adding "Analysis", "Report", and "Tools" menu items and toolbars. It performs real-time and offline analysis functions and displays analysis results in separate windows in the UI, which can be accessed via the "Analysis" and "Reports" menu items.

The NF ERP Module is a separate evoked response potential (ERP) module that can control and get data from the Q21 EEG system and performs typical ERP functions like stimulus presentation, EEG epoching, epoch averaging, reaction time, and ERP display. The NF ERP Module is a separate stand-alone application.

Intended Use/Indications for use

The NeuroField Analysis Suite is to be used by qualified medical and qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and eventrelated potentials (ERP).

Substantial Equivalence Comparison

Based upon comparisons of regulatory parameters, features, and performance evaluations, the NeuroField EEG Analysis module of the NeuroField Analysis Suite is substantially equivalent to the primary predicate device, NeuroGuide Analysis System (K041263), and the NeuroField ERP functions are substantially equivalent to the secondary predicate device, eVox System (K171781).

The comparison between the NeuroField Analysis Suite, the primary predicate NeuroGuide Analysis System (K041263) and the secondary predicate eVox System (K171781) below consists of a series of tables followed by explanations of the similarities and differences described in each table.

III. Comparison of Regulatory Parameters

Comparison	NeuroField Analysis Suite	Primary Predicate:NeuroGuide AnalysisSystem (K041263)	Secondary Predicate:eVox System (K171781)
------------	---------------------------	---------------------------------------------------------------	-----------------------------------------------

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Indicationsfor use	The NeuroField AnalysisSuite is to be used byqualified medical andqualified clinicalprofessionals for thedisplay and storage ofelectrical activity of apatient's brain, includingthe post-hoc statisticalevaluation of the humanelectroencephalogram(EEG) and event-relatedpotentials (ERP).	The NeuroGuideAnalysis system is to beused by qualifiedmedical and qualifiedclinical professionals forthe post-hoc statisticalevaluation of thehumanelectroencephalogram(EEG).	The eVox System isintended for theacquisition, display, andstorage, of electricalactivity of a patient'sbrain includingelectroencephalograph(EEG) and event-relatedpotentials (ERP) obtainedby placing two or moreelectrodes on the headto aid in diagnosis.
Intendedpopulation	Patients of all ages.	Patients of all ages (“2months to 82 years”).	All age groups.
Common orusual name	Normalizing QuantitativeElectroencephalographSoftwareStimulator, Auditory,Evoked Response	Normalizing QuantitativeElectroencephalographSoftware	Full MontageElectroencephalographStimulator, Auditory,Evoked Response
RegulatoryClass	Class II	Class II	Class II
Classificationname andproduct code	882.1400ElectroencephalographOLU882.1900 Evoked responseauditory stimulator GWJ	882.1400ElectroencephalographOLU	882.1400ElectroencephalographGWQ882.1900 Evokedresponse auditorystimulatorGWJ

Discussion of Similarities and Differences

The NeuroField Analysis Suite and the primary predicate are materially the same in regulatory parameters:

Both are Normalizing Quantitative Electroencephalograph Software that can be ● used with all ages of patients
Both are for statistical evaluation of the human electroencephalogram (EEG)
Both have the same classification name, primary product code, and regulatory class

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The Indications for Use of the NeuroField Analysis Suite consist of a combination of the Indications for use of the predicate ("The NeuroGuide Analysis system is to be used by qualified medical and qualified clinical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG).") and the relevant section of the Indications for Use of the secondary predicate ("display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP)".

The secondary predicate is provided because of its event-related potentials (ERP) features, compared below.

IV. Comparison of Features – EEG Analysis (OLU)
Category	Comparison	NeuroField Analysis Suite	Primary Predicate:NeuroGuide Analysis System (K041263)
General	Default File Format	Proprietary nfx format	Proprietary ng format
	Supported Open File Standards	EDF, EDF+, XDF	EDF, EDF+
	Supported Device and Vendors	Neurofield Q21	Neurofield Q21 and various other vendors
	Re-montaging	Yes	Yes
	IIR Filtering	Yes	Yes
	Notch Filtering	Yes	Yes
	Add Event Markers	Yes	Yes
	Analyze Whole Data	Yes	Yes
	Analyze Selected Interval	Yes	Yes
	Analyze Selected Markers only	Yes	No
PowerAnalysis	Absolute PowerRaw/Z-Scores	Yes	Yes
	Relative Power Raw / Z-Scores	Yes	Yes
	Power Ratios Raw / Z-Scores	Yes	Yes
	Head Maps	Yes	Yes
	FFT Spectrum	Yes	Yes
	FrequencyResolution	0.5 Hz	0.5 Hz
	Single FrequencySide-Lobe	< -60 dB	First Sidelobe at -45 dB
	Tabular Export or View	Yes	Yes
	Automated Report	Yes	Yes

IV. Comparison of Features - EEG Analysis (OLU)

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	Model	Key Institute 2394 Voxel LORETA Model	Key Institute 2394 Voxel LORETA Model
LORETA	Atlas	Brodmann	Brodmann
	3-D Cortex View	Yes	Yes (throughNeuroNavigator Add-on)
	Current Density –Raw	Yes	Yes
	Current Density – ZScores	No	Yes
	Absolute Power –Raw	Yes	Yes
	Absolute Power – ZScores	No	Yes
	Coherence / PhaseMetrics	No	Yes

Discussion of Similarities and Differences

The NeuroField Analysis Suite and the primary predicate are substantially equivalent with respect to the implementation of most standard Quantitative Electroencephalograph Software features, including:

Both perform re-montaging, filtering, adding event markers, and analysis based upon markers or whole data.
Both generate Z-Scores for absolute power and relative power of EEG bands or individual frequencies.
Both generate head maps and FFT spectra, and with equivalent frequency resolution.
Both provide for tabular export and automated report generation.
Both can calculate the inverse solution (using the standard LORETA Key Institute 2394 LORETA model) and generate the current densities and powers of the ROIs (Region of Interest) over the cortex using the Brodmann Atlas.
Both can read standard EDF and EDF+ files.

The two systems differ with respect to file format support and LORETA Z-scoring:

The NeuroField Analysis Suite can read/export XDF files in addition to EDF / EDF+ . files.
The predicate can read various proprietary EEG file formats from EEG amplifier vendors.
. The predicate generates Z-Scores for the LORETA solution and calculates coherence and phase metrics between the regions.

These differences are minor, and do not materially affect their substantial equivalence with respect to technological basis or use.

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Comparison	NeuroField Analysis Suite	Secondary Predicate:eVox System (K171781)	Comment
ERP StimulusModality	Auditory; Visual	Auditory; Visual
ERPParadigm(AuditoryandVisualStimuli)	P300 Oddball- Single StimulusSimple Go/No-GoCued Go/No-GoActive	P300 Oddball- Single Stimulus- Single Deviant- 2 Deviant- Active and Passive
ERP TaskResponse	Mouse click	User Buttons
Number ofSignalRecordingChannels	Up to 38	Up to 21
RecordingChannelsLocationandPositioningSystems	Consistent with the 10-20System	Fz, Cz, Pz, F3, P3, F4, P4Utilizing elastic bandsusing distance ratiosconsistent with the 10-20System
ImpedanceTest	Yes	Yes
InterfacewithAmplifier	USB-CAN	Class 2 Bluetoothversion2.0 to PC
Filtering	User Definable for Visualinspection of the EEG inthe 0.1 – 128 Hz range.The underlying softwarealways retains and savesthe unfiltered data so thatit can be visualized undervarious filtering settingsduring postprocessing.	0.1 to 50 Hz
AudioFrequencyRange	500 Hz, 1 kHz, userdefinable. NF-ERP usesthe operating systemcapabilities to generatethe audio. Therefore, the	440Hz-16kHz	NF ERP module hasdefault 500 Hz and1 kHz audio stims.These stims can bealtered by the user
	clinician user can change		The eVox system
	the stimulus waveform.		generates a sound
	The default is: No-Go		with a frequency
	Stimulus: 500 kHz, Go		range of 440Hz-
	Stimulus: 1 kHz		16kHz which is a
			sufficiently wide
			enough band for
			human hearing.
AudioIntensity	User computer volumesetting	0 to 85dB
TechnologicalDifferencesin how usersadministerand set tasksfor evokedresponsestimulation	NF-ERP uses the computersystem clock, and themicrosecond time stampson the USB-CAN interfaceto time lock (synchronize)EEG data samples, stimuliand the user responses.NF-ERP uses computermouse to record userresponses.	Specific details of theeVox system areproprietary to themanufacturer. Based onthe available data:The eVox system, likeNF-ERP, uses customsoftware specificallydesigned to presentstimuli (auditory orvisual) to the patient.The software controlsthe timing of stimuluspresentation and sendstriggers to the EEGacquisition systemensuring millisecondaccuracy.eVox system uses USB-based triggering torecord user events(response button)	Both systems usesimilartechnologies fortime locking anduser events.
User-definedTaskParameters	- ERP Paradigm(Visual or auditory)– see above- Active ERP (useralways respondsto the Go stimuli)- Enable / DisableWarning Stimulus- Enable / disableripple effect onthe stimuli (for	- ERP Paradigm(Visual orauditory)- seeabove- Active orPassive ERP- Volume Setting	Both systems usesimilartechnologies fortime locking anduser events. It isnot clear in theeVoxdocumentationwhether it uses useadjustable stimulusperiod, number of

V. Comparison of Features – ERP Analysis (GWJ)

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Simple Go-No/Go paradigm)- Stimulus period(for oddball paradigm)- Go stimulus probability- Number of cycles- Task page background color.Volume Setting	cycles, or Go stimulus probability.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------

The NeuroField ERP module and the secondary predicate are substantially equivalent with respect to the implementation of most standard ERP features, including:

Both generate averaged ERP graphs for the EEG channels, allowing the user to measure the latency and magnitude of the evoked potentials.
. Both allow for customizable session length.
Both apply the auditory and visual oddball paradigm, where the user is presented with a periodic common stimuli and the frequency or the duration (in the case of auditory stimulus) or the image (in the case of visual stimuli) is altered infrequently, making it the oddball.
Both allow the user to set parameters for the visual and auditory oddball paradigm.

The two systems differ in a few ways:

In the Neurofield ERP Module, the filtering is user definable, whereas in eVox system, it is fixed to a 0.1 - 50 Hz bandpass.
. The Neurofield ERP module interface with the device is USB-CAN, whereas the eVox System uses Bluetooth.
. The Neurofield ERP module uses standard 19-channels, whereas eVox uses only a subset of the standard (7 channels).

These differences are minor, and do not materially affect their substantial equivalence with respect to technological basis or use.

VI. Comparative Performance Evaluations

NF EEG Analysis module and Neuroguide perform similar QEEG analysis on Eyes Closed and Eyes Open task recorded EEG data. Both programs generate Z-Scores for absolute power and relative power of EEG bands or individual frequencies. They can also calculate the inverse solution (using the standard LORETA Key Institute 2394 LORETA model) and generate the current densities and powers of the ROIs (Region of Interest) over the cortex using the Brodmann Atlas. They can read standard EDF and EDF+ files. NF EEG, like Neuroguide, can read/export EDF/EDF+ files. NF-EEG also has XDF file format support. On

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the other hand, Neuroguide can read various proprietary EEG file formats from EEG amplifier vendors.

Comparative performance evaluations showed that the same EDF file, loaded to NF-EEG and Neuroguide shows comparable signals on the EEG Plot. When the spectrums are calculated, the result from both programs shows comparable spectrum and sidelobes both for real and simulated data. Both programs show comparable Z-Scores. The visualization of headmaps in both programs also shows comparable topographies over the standard EEG bands. Therefore, NF-EEG demonstrates a comparable performance to the predicate device.

NF ERP Module and eVox System perform similar ERP recording and analysis. Both programs can generate averaged ERP graphs for the EEG channels, allowing the user to measure the latency and magnitude of the evoked potentials. Both programs apply variations of the oddball paradigm, where the user is presented with a periodic common stimulus and the frequency or the duration (in the case of auditory stimulus) or the image (in the case of visual stimuli) is altered infrequently, making it the oddball. In the Neurofield ERP Module, more parameters are user-definable, like the visual filtering, oddball period, Go probability. Clinician also can customize the audio or visual stims. Also, Neurofield ERP module uses 10-20 standard 19-channels or 38- channels, whereas eVox uses a subset of the standard (7 channels).

Since an ERP test requires perfect synchronization between the stimulus time recording and EEG data, comparative performance evaluations were not performed directly between the Neurofield ERP and eVox systems. Instead, a mathematical validation of NF-ERP was performed. This mathematical assessment shows that the generated averaged ERPs are mathematically correct. Moreover, the analysis of real data shows that the NF-ERP can elicit correct ERP components, the generated stimulus is reliable, and the split-half reliability measure confirms test reliability. As a result, the NF-ERP and eVox systems will both produce comparable, mathematically correct oddball ERPs, and the NF-ERP performs that task as well as the predicate device.

VII. Clinical Performance Evaluations

Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device.

VIII. Conclusion

The devices have materially the same indications for use and the same classifications. They have most of the same features. They are used on the same populations. The two products are different in minor ways that do not materially affect their technological basis or use.

Based upon comparisons of regulatory parameters, features, and performance evaluations, the NeuroField Analysis Suite is substantially equivalent to the primary predicate device,

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NeuroGuide Analysis System (K041263), and the NeuroField ERP functions are substantially equivalent to the secondary predicate device, eVox System (K171781).

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).