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

Device Description

NeuroMatch is a cloud-based software as a medical device (SaMD) intended to review, monitor, display, and analyze previously acquired and/or near real-time electroencephalogram (EEG) data from patients 18 years old or older. The device is not intended to substitute for real-time monitoring of EEG. The software includes advanced algorithms that perform artifact reduction, seizure detection, and spike detection.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the NeuroMatch device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For Seizure Detection:

Metric	Acceptance Criterion (Non-Inferiority)	NeuroMatch Performance (Mean [95% CI])	Predicate (Persyst 14) Performance (Mean [95% CI])	Met Criterion?
Sensitivity	Upper limit of 95% CI for (Persyst 14 - NeuroMatch) < 10%	75.01 [72.62, 77.57]	59.37 [56.94, 61.71]	Yes
FDR (per 24 hrs)	Lower limit of 95% CI for (Persyst 14 - NeuroMatch) > -4 per 24hr	3.74 [2.59, 5.44]	4.26 [3.15, 7.39]	Yes

For Spike Detection:

Metric	Acceptance Criterion (Non-Inferiority)	NeuroMatch Performance (Mean [95% CI])	Predicate (Persyst 14) Performance (Mean [95% CI])	Met Criterion?
Sensitivity	Upper limit of 95% CI for (Persyst 14 - NeuroMatch) < 15%	72.18 [66.81, 77.54]	67.92 [61.96, 73.87]	Yes
FDR (per minute)	Lower limit of 95% CI for (Persyst 14 - NeuroMatch) > -1.5 per minute	3.24 [2.15, 4.33]	3.61 [2.68, 4.53]	Yes

2. Sample Sizes and Data Provenance

For Seizure Detection Validation:

Test Set Sample Size:
- Patients: 181 patients with at least 1 verified seizure event, and 10 control patients with 0 verified seizure events.
- EEG Hours: 979.40 hours from seizure patients, 80 hours from control patients.
- Events: 504 events used for sensitivity calculation (capped at 6 events per patient).
Data Provenance: Data collected from three independent and geographically diverse medical institutions. The document indicates this data was "completely separate and independent from the data used to design and train the algorithm," implying it is retrospective data. Country of origin is not explicitly stated but implied to be the US based on the FDA submission.

For Spike Detection Validation:

Test Set Sample Size:
- Patients: 149 patients with at least 1 verified spike event.
- Total EEG minutes (hours): 2752.72 minutes (~45.9 hours).
Data Provenance: Data collected from three independent and geographically diverse medical institutions. This dataset was also "completely separate and independent from the data used to design and train the algorithm," indicating retrospective data. Country of origin is not explicitly stated.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Three independent EEG-trained neurologists.
Qualifications of Experts: EEG trained neurologists. More specific details like years of experience are not provided.

4. Adjudication Method for the Test Set

Seizure Detection: A reference standard was established by a panel of three independent EEG trained neurologists. Seizures were identified based on a 2 out of 3 majority rule.
Spike Detection: The reference standard was established by a panel of three independent EEG trained neurologists. Spikes were identified with majority consensus among the annotating physicians (i.e., consensus of at least 2 out of the 3 physicians).

5. MRMC Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance versus without AI assistance was not explicitly described in the provided text. The study compares the algorithm's performance (NeuroMatch) to a predicate algorithm's performance (Persyst 14), not human performance.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done for both seizure and spike detection. The results presented in the tables are direct comparisons between the NeuroMatch algorithm and the Persyst 14 predicate algorithm, both run on the validation dataset against a ground truth established by experts.

7. Type of Ground Truth Used

The ground truth used for both seizure and spike detection was expert consensus, specifically "consensus of at least 2 out of the 3 physicians" (majority rule) from independent EEG-trained neurologists.

8. Sample Size for the Training Set

The sample size for the training set is not explicitly provided in the given document. The document states that the validation dataset "was completely separate and independent from the data used to design and train the algorithm," but it does not specify the details of the training data.

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

The method for establishing ground truth for the training set is not explicitly provided in the document. It only states that the validation set was independent of the data used for training and design.

Summary

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November 26, 2024

LVIS Corporation % Devjani Saha, PhD Director, Neurology Regulatory Affairs MCRA, Llc 803 7th St NW. 3rd Floor Washington, District of Columbia 20001

Re: K241390

Trade/Device Name: NeuroMatch Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OLT, OMA Dated: October 24, 2024 Received: October 25, 2024

Dear Devjani Saha:

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.

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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" (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 QS 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 Rule"). 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-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-regulatory

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assistance/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).

Sincerely,

Patrick Antkowiak -S

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) K241390

Device Name NeuroMatch

Indications for Use (Describe)

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Applicant Information:

LVIS Corporation 2600 E. Bayshore Rd., Palo Alto, CA 94303

Contact Person:

Sweta Srivastava Head of Regulatory Affairs Email: ssrivastava@lviscorp.com Phone: 415-997-7337

Device Information:

Trade Name:	NeuroMatch
Common Name:	Automatic Event Detection Software For Full-Montage Electroencephalograph
Classification Name:	Electroencephalograph (21CFR 882.1400)
Device Class:	II
Product Code:	OMB, OLT, OMA

Predicate Device:

Persyst 14, EEG Review and Analysis Software, K182181

Date Prepared:

November 25, 2024

Device Description:

The subject device is identical to the NeuroMatch device cleared under K222450, with exception of the following additional features:

1. Spike detection;
1. Seizure detection;

Seizure and spike detection are substantially equivalent to the Persyst 14 device (K182181: Predicate). Apart from the proposed additional software changes and associated changes to the Indications for Use and labeling, there are no changes to the intended use or to the software features that were previously cleared. Below is a description of the software functions that will be added to the cleared NeuroMatch Device.

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1. Spike Detection

NeuroMatch Spike Detection identifies both spike waves and sharp waves. The NeuroMatch Spike Detection feature uses a deep learning-based algorithm that detects potential epileptiform spikes and annotates each detected potential spike with a unique identification. The detection of spikes in the EEG data is automatically triggered when an EEG file is uploaded by the user. The NeuroMatch Spike Detection feature identifies spikes and displays the spikes based upon the order (time) when the spike occurred.

2. Seizure Detection

The NeuroMatch Seizure Detection feature uses a deep learning-based algorithm to identify potential seizure events and annotates each detected potential seizure with a unique identification. Each annotation includes the start and end positions of the potential identified seizures.

Indications for Use:

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

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Comparison of Intended Use and Technological Characteristics with the Predicate Devices:

TABLE 1: NEUROMATCH SUBSTANTIAL EQUIVALENCE TABLE

Device	NeuroMatch(Proposed Device)K241390LVIS	Persyst 14 EEG Review andAnalysis Software(Predicate Device)K182181Persyst DevelopmentCorporation	Rationale forSubstantialEquivalence
Classification	21 CFR§882.1400,Electroencephalograph	21 CFR§882.1400,Electroencephalograph	Sameclassification asthe Predicatedevice.
Product Code	OMB, OLT, OMA	OMB, OLT, OMA	Same productcode as thePredicate device.
Indications for Use:For the subject device newindications are highlightedin bold while previouslycleared indications are innormal font.	1. LVIS NeuroMatchSoftware is intended forthe review, monitoringand analysis ofelectroencephalogram(EEG) recordings madeby EEG devices usingscalp electrodes and toaid neurologists in theassessment of EEG. Thedevice is intended to beused by qualified medicalpractitioners who willexercise professionaljudgment in using theinformation.2. The Seizure Detectioncomponent of LVISNeuroMatch is intendedto mark previouslyacquired sections ofadult EEG recordingsfrom patients greaterthan or equal to 18years old that maycorrespond toelectrographic seizures.	1. Persyst 14 EEG Reviewand Analysis Software isintended for the review,monitoring and analysisof EEG recordings madeby electroencephalogram(EEG) devices usingscalp electrodes and toaid neurologists in theassessment of EEG. Thedevice is intended to beused by qualified medicalpractitioners who willexercise professionaljudgment in using theinformation.2. The Seizure Detectioncomponent of Persyst 14is intended to markpreviously acquiredsections of adult (greaterthan or equal to 18 years)EEG recordings that maycorrespond toelectrographic seizures, inorder to assist qualifiedclinical practitioners in	The ProposedDevice and thePredicate, havesimilarIndications forUse. TheProposedDevice'sIndications forUse wasdeveloped toincorporatewording fromthe predicatedevice.
Device	NeuroMatch(Proposed Device)K241390LVIS	Persyst 14 EEG Review andAnalysis Software(Predicate Device)K182181Persyst DevelopmentCorporation	Rationale forSubstantialEquivalence
	in order to assistqualified medicalpractitioners in theassessment of EEGtraces. EEG recordingsshould be obtained witha full scalp montageaccording to theelectrodes from theInternational Standard10-20 placement.	the assessment of EEGtraces. EEG recordingsshould be obtained with afull scalp montageaccording to the standard10/20 system.
	3. The Spike Detectioncomponent of LVISNeuroMatch is intendedto mark previouslyacquired sections ofadult EEG recordingsfrom patients ≥18 yearsold that maycorrespond to spikes, inorder to assist qualifiedmedical practitioners in	3. The Spike Detectioncomponent of Persyst 14is intended to markpreviously acquiredsections of the patient'sEEG recordings that maycorrespond to spikes, inorder to assist qualifiedclinical practitioners inthe assessment of EEGtraces. The SpikeDetection component isintended to be used inpatients at least onemonth old. Persyst 14Spike Detectionperformance has not been
	the assessment of EEGtraces. LVISNeuroMatch SpikeDetection performancehas not been assessedfor intracranialrecordings.	assessed for intracranialrecordings.
	4. LVIS NeuroMatchincludes the calculationand display of a set ofquantitative measuresintended to monitor andanalyze EEG waveforms.These include Artifact	4. Persyst 14 includes thecalculation and display ofa set of qualitativemeasures intended tomonitor and analyze theEEG waveform. Theseinclude FFT,Rhythmicity, PeakEnvelope, ArtifactIntensity, Amplitude,Relative Symmetry andSuppression Ratio.Automatic event marking
Device	NeuroMatch(Proposed Device)K241390LVIS	Persyst 14 EEG Review andAnalysis Software(Predicate Device)K182181Persyst DevelopmentCorporation	Rationale forSubstantialEquivalence
	Strength, AsymmetrySpectrogram,AutocorrelationSpectrogram, and FastFourier Transform (FFT)Spectrogram. Thesequantitative EEGmeasures should alwaysbe interpreted inconjunction with reviewof the original EEGwaveforms.5. LVIS NeuroMatchdisplays physiologicalsignals such aselectrocardiogram(ECG/EKG) if it isprovided in the EEGrecording.6. The aEEG functionalityincluded in LVISNeuroMatch is intendedto monitor the state of thebrain.7. LVIS NeuroMatchArtifact Reduction (AR)is intended to reducemuscle and eyemovements, in EEGsignals from theInternational Standard10-20 placement. ARdoes not remove theentire artifact signal andis not effective for othertypes of artifacts. ARmay modify portions ofwaveforms representing	is not applicable to thequantitative measures.These quantitative EEGmeasures should alwaysbe interpreted inconjunction with reviewof the original EEGwaveforms.5. Persyst 14 displaysphysiological signals,including the calculationand display of a heart ratemeasurement based onthe ECG channel in theEEG recording, which areintended to aid in theanalysis of an EEG.Heart rate measurementof Persyst 14 is notapplicable to patients withpacemaker and/or activeimplantable devices.6. The aEEG functionalityincluded in Persyst 14 isintended to monitor thestate of the brain. Theautomated event markingfunction of Persyst 14 isnot applicable to aEEG.7. Persyst 14 providesnotifications for seizuredetection, quantitativeEEG and aEEG that canbe used when processinga record duringacquisition. Theseinclude an on screendisplay and the optional
Device	NeuroMatch(Proposed Device)K241390LVIS	Persyst 14 EEG Review andAnalysis Software(Predicate Device)K182181Persyst DevelopmentCorporation	Rationale forSubstantialEquivalence
	cerebral activity.Waveforms must still beread by a qualifiedmedical practitionertrained in recognizingartifacts, and anyinterpretation ordiagnosis must be madewith reference to theoriginal waveforms.8. This device does notprovide any diagnosticconclusion about thepatient's condition to theuser.	sending of an emailmessage. Delays of up toseveral minutes can occurbetween the beginning ofa seizure and when thePersyst 14 notificationswill be shown to a user.Persyst 14 notificationscannot be used as asubstitute for real timemonitoring of theunderlying EEG by atrained expert.8. Persyst AR (ArtifactReduction) is intended toreduce EMG, eyemovement, and electrodeartifacts in a standard 10-20 EEG recording. ARdoes not remove theentire artifact signal, andis not effective for othertypes of artifacts. ARmay modify portions ofwaveforms representingcerebral activity.Waveforms must still beread by a qualifiedmedical practitionertrained in recognizingartifact, and anyinterpretation or diagnosismust be made withreference to the originalwaveforms.9. This device does notprovide any diagnostic
Device	NeuroMatch(Proposed Device)K241390LVIS	Persyst 14 EEG Review andAnalysis Software(Predicate Device)K182181Persyst DevelopmentCorporation	Rationale forSubstantialEquivalence
		patient's condition to theuser.
Prescription/Over-the-Counter	Rx	Rx	Same as thePredicate device.
Patient Population	Individuals ≥18 yearsundergoing EEG assessment	Adults and pediatric patientsundergoing EEG assessment:Seizure detection:- Individuals ≥18 years- Spike detection atleast one month old	Similar, theProposed Deviceage group of atleast 18 yearsold for seizuredetection is thesame as thepredicate device.For spikedetection, thesubject device isintended for asubset of thepopulation that iscleared for thepredicate device.
Components	SaMD	SaMD	Same as thePredicate device.
EEG Data Source		10-20 system	10-20 system (spike andseizure detection)¹ up to 256channels²	Similar, theProposed Deviceand the Predicateboth use 10-20system.
EEGFunctions	Review,Monitor, andAnalyzeRecordings	Yes	Yes	Same as thePredicate device.
	AnnotationList	Yes	Yes	Same as thePredicate device.
Device	NeuroMatch(Proposed Device)K241390LVIS	Persyst 14 EEG Review andAnalysis Software(Predicate Device)K182181Persyst DevelopmentCorporation	Rationale forSubstantialEquivalence
Measurements	Previously Cleared:• FFT Spectrogram• Artifact Strength• aEEG• Autocorrelation Spectrogram• Asymmetry SpectrogramAdded in Current 510(k):• Seizure Detection• Spike Detection	• FFT• Artifact Intensity• Amplitude• Rhythmicity• Peak Envelope• Relative Symmetry• Suppression Ratio• Artifact intensity• FFT spectrogram• FFT power• FFT power ratio• FFT spectral edge• Relative asymmetry spectrogram• Absolute asymmetry index• Relative asymmetry index• aEEG• Rhythmicity spectrogram• Spike detection• Spike density• Seizure detection• Seizure probability• Spike Perception Score• VSBASLINE3	The Proposed Device and thePredicate both provide seizureand spike detection.
Seizure Detection	Yes, full montage	Yes, full montage	Same as thePredicate device.
Spike Detection	Yes	Yes	Same as thePredicate device.
Notifications	No	Yes, notifications for seizuredetection, quantitative EEG,and aEEG.	This difference to the Predicatedoes not raise differentquestions of safety andeffectiveness as the clinicianshould be
Device	NeuroMatch(Proposed Device)K241390LVIS	Persyst 14 EEG Review andAnalysis Software(Predicate Device)K182181Persyst DevelopmentCorporation	Rationale forSubstantialEquivalence
			reviewing andanalyzing alldata includingthe original EEGwaveformsholistically.

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¹ Persyst 14 User Manual, Persyst 14 Spike and Seizure Detection Description ² Persyst 14c Release Notes, Persyst EEG Electrical Source Imaging (ESI),

https://www.persyst.com/support/persyst-release-notes/

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Performance Data:

The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:

Non-Clinical Testing

Software verification and validation testing ●

The following software verification and validation tests were completed per FDA's guidance entitled "Content of Premarket Submissions for Device Software Functions" issued June 2023:

Verification Tests and Regression Tests o
Unit/Module Level and Integration Testing O
Visualization Testing O
o Performance Testing

All tests successfully met their respective acceptance criteria and confirmed the software met its requirements and design.

. Cybersecurity Testing

A comprehensive battery of cybersecurity testing per FDA's guidance entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (issued September 2023), including Configuration Assessment, Vulnerability Scanning, and Penetration Testing, was conducted.

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Clinical Testing ●

Seizure Detection Validation:

Clinical Sites:

Validation of the NeuroMatch seizure detection feature was conducted using EEG data collected in three independent and geographically diverse medical institutions.

Dataset Characteristics and subject demographics:

The demographics of seizure detection validation dataset are as follows:

	Patientwith at least 1 verified seizureevent	ControlWith 0 verified seizure event
Number of subjects	181	10
Total EEG hours	979.40	80
(mean, median, [min, max])	(5.41, 6.0, [1.00, 8.00])	(8.00, 8.00, [8.00, 8.00])
Age, years (mean)	42.05	52.3
(median and [min, max])	(39, [18, 89])	(60, [25, 78])
Gender(Male : Female)	95:86	4 : 6

Summary of Validation Testing

The following is a summary of the validation procedure performed:

. A validation dataset of EEG recordings obtained from adult (18 years and older) patients were utilized for validation testing. This dataset was completely separate and independent from the data used to design and train the algorithm.
. A reference standard was established for the validation dataset by a panel of three independent EEG trained neurologists who reviewed and annotated the EEG recordings for seizure episodes. Seizures were identified based on a 2 out of 3 majority rule.
. Both NeuroMatch and predicate Persyst 14 (K182181) Seizure Detection modules were run on the validation dataset and performance metrics were calculated for each as compared to the reference standard established per above.
. Statistical analysis was performed on the results to evaluate non-inferiority to the predicate device based on both sensitivity and false detection rate (FDR).
. Conducting an event-level analysis, with potentially an unlimited number of events per patient, introduces bias by disproportionately affecting the data distribution in favor of patients with many events. To avoid such bias, the study reports an event-level analysis with a capping value of six events per patient for seizure detection sensitivity.

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Results:

	Sensitivity(N = 504 events)	False Detection Rate (FDR)(per 24 hrs)
Persyst 14	59.37 [56.94, 61.71]	4.26 [3.15, 7.39]
NeuroMatch	75.01 [72.62, 77.57]	3.74 [2.59, 5.44]

NeuroMatch and Persyst 14 sensitivity and false detection rate. Mean and 95% confidence intervals are shown.

Sensitivity: The acceptance criterion for non-inferiority required the upper limit of the 95% CI for the difference in sensitivity (Persyst 14- NeuroMatch) to be less than 10%. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

FDR: The acceptance criterion for non-inferiority required the lower limit of the 95% CI for the difference in FDR (Persyst 14-NeuroMatch) to be greater than -4 per 24hr. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

Conclusion:

NeuroMatch Seizure Detection passed non-inferiority testing to the Persyst14 ( K182181), in both sensitivity and false-detection rate (FDR).

Spike Detection Validation:

Clinical Sites:

Validation of the NeuroMatch spike detection feature was conducted using EEG data collected in three independent and geographically diverse medical institutions.

Dataset Characteristics and Subject Demographics Summary Table:

The demographics of spike detection validation dataset are as follows:

	Patient
	with at least 1 verified spike event
Number of subjects	149
Total EEG minutes (hours)	2752.72 (~45.9)
(mean, median, [min, max])	(18.47, 20 [10.0,0 20.00])
Age (mean)	42.56
(median, [min, max])	(39, [18, 92])
Gender(Male : Female : Unspecified -Number of Subjects)	73 : 75 : 1

{16}------------------------------------------------

Summary of Validation Testing

The following is a summary of the validation procedure performed:

A validation dataset of EEG recordings obtained from adult (18 years and older) . patients were utilized for validation testing. This dataset was completely separate and independent from the data used to design and train the algorithm.
. A reference standard was established for the validation dataset by a panel of three independent EEG trained neurologists who reviewed and annotated the EEG recordings for spike events. The reference standard for spike is established with majority consensus among the annotating physicians (i.e., consensus of at least 2 out of the 3 physicians).
. Both NeuroMatch and predicate Persyst 14 (K182181) Spike Detection modules were run on the validation dataset and performance metrics were calculated for each as compared to the reference standard established per above.
. Statistical analysis was performed on the results to evaluate non-inferiority to the performance of the predicate device in terms of sensitivity and false detection rate.

Results:

	Sensitivity	False Detection Rate(FDR)(per minute)
Persyst 14	67.92 [61.96, 73.87]	3.61 [2.68, 4.53]
NeuroMatch	72.18 [66.81, 77.54]	3.24 [2.15, 4.33]

NeuroMatch and Persyst 14 sensitivity and false detection rate. Mean and 95% confidence intervals are shown.

Conclusion:

Sensitivity: The acceptance criterion for non-inferiority required the upper limit of the 95% CI for the difference in sensitivity (Persyst 14 - NeuroMatch) to be less than 15%. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

FDR: The acceptance criterion for non-inferiority required the lower limit of the 95% CI for the difference in FDR (Persyst 14-NeuroMatch) to be greater than -1.5 per minute. This criterion was met, confirming that NeuroMatch is non-inferior to Persyst 14.

Summary:

The NeuroMatch device has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the NeuroMatch device is substantially equivalent to the cleared 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).