The Nurochek System is intended for prescription use in healthcare facilities or clinical research environments for subjects ages 14 years and older. The Nurochek System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display and store electroencephalograms (EEGs) during the generation of VEPs. The Nurochek System only acquires and displays physiological signals: no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision and reliability.

Device Description

The Nurochek System combines hardware, firmware and software to generate and acquire physiological signals, specifically, VEPs. These VEPs are generated by a visual stimulus delivered through the Nurochek headset worn by the subject. This visual stimulus is a short-duration flash of white light. The Nurochek headset acquires the VEPs from the rear of the head and transmits the resulting EEG to the Nurochek software application to be displayed to the user and stored. These acquired signals are intended to be analyzed by a Physician. The Nurochek System operates on the principles of generating VEPs via photic simulation and acquiring the VEPs via EEG. Photic stimulation is provided through short-duration flashes of white light from multiple LEDs located in the front of the headset to direct the stimulus into the subject's eyes. The VEPs are acquired by an EEG comprising of a total of 5 electrode interfaces with hydrophilic foam cylinders saturated with saline solution to provide electrical contact to the subject's scalp. A Bluetooth receiver and transmitter located within the Nurochek headset allows it to communicate with and be controlled by the Nurochek software application. The Nurochek software application provides a graphical user interface which allows: Collection of the subject details and consent, Initiation of a study and tracking of patient information, Acquisition and transmission of signals wirelessly to and from the headset, Display of the contact quality of electrodes to the subject's scalp, Recording, processing and display of EEG signals received from the headset, and Manage previous EEG recordings of VEPs.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the Nurochek System, focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a detailed clinical study with performance metrics. While it mentions non-clinical performance data and a small clinical study, it does not explicitly provide a table of acceptance criteria with corresponding performance data in the format requested.

The document states that "The Nurochek System only acquires and displays physiological signals: no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision and reliability." This statement is critical as it limits the scope of claims and thus the type of performance data required for acceptance. The study described focuses on functional equivalence in signal acquisition rather than diagnostic accuracy.

Despite this, I can extract information related to the device's performance based on the functional capabilities and a small clinical study mentioned.

Here's an attempt to answer your request based on the provided text, acknowledging the limitations in scope for a device that "only acquires and displays physiological signals and makes no claims in relation to diagnoses."

1. Table of acceptance criteria and the reported device performance:

Since the document defines the device as one that "only acquires and displays physiological signals" and makes "no claims ... for the analysis of the acquired signals with respect to the accuracy, precision and reliability," the acceptance criteria are not in terms of diagnostic performance (e.g., sensitivity, specificity). Instead, they are related to the functional equivalence of signal acquisition and display compared to a benchmark device, and safety/technical compliance.

Acceptance Criterion (Implicit based on device capabilities and comparison)	Reported Device Performance (from "NON-CLINICAL PERFORMANCE DATA" and "CLINICAL STUDIES")
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2 (EMC), and IEC 60601-2-40. All test results demonstrated compliance.
Light Safety	Compliance with ISO 15004-2:2007 and ANSI Z80.36-2016. Nurochek Headset classified as a Group 1 Instrument by both standards ("ophthalmic instruments for which no potential light hazard exists").
Biocompatibility	Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-10 (Irritation). All contacting parts were evaluated (foam cylinders, strap components). Results demonstrated that materials in contact with the patient are biocompatible.
Cleaning and Disinfection	Validation per FDA Guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling" and AAMI TIR30/TIR12. All tests passed, demonstrating appropriate cleaning methods for between uses.
Mechanical Durability	Cyclic testing to ensure required use lifetime; Drop, impact, and push tests per IEC 60601-1 Ed. 3.1. All tests passed, demonstrating compliance and sufficient resilience against foreseeable misuse.
Firmware and Software Functionality	Verification and validation per FDA "Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software in Medical Devices'" and IEC 62304. Results demonstrated software meets requirements for safety, function, and intended use.
Functional Equivalence in SSVEP Detection (Clinical)	"The study concluded that both systems functioned identically in their ability to detect SSVEPs." This refers to the Nurochek System and the Compumedics Grael EEG reference device using a common visual stimulus. The exact quantitative measure of "identically" is not provided beyond this qualitative statement within the summary.
Adverse Events (Clinical)	"All tests were performed successfully with no adverse events."
EEG Signal Acquisition Characteristics (Comparison to Predicate X-Series System, Table 1)	- Sampling Rate: Nurochek: 250 s/s vs. Predicate: 256 s/s (Equivalent, difference only dictates max frequency).- Dynamic Range: Nurochek: +/- 187,500 μV (superior) vs. Predicate: +/- 1000μV.- Resolution: Nurochek: 0.02μV (superior/more accurate) vs. Predicate: 0.03μV.- Peak to Peak Noise: Nurochek: 1.97μV (typical) (lower/superior) vs. Predicate: 3.7μV (typical).- Common Mode Rejection Ratio: Nurochek: 110 dB vs. Predicate: 110 dB (same).- Input Impedance: Nurochek: 1GOhm vs. Predicate: 100GOhm (Both exceed OSET recommendation of 10 MOhm).- Impedance Check Functionality: Both have impedance check.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: 20 participants for the clinical study comparing SSVEP detection.
Data Provenance: The document does not explicitly state the country of origin for the clinical study data or if it was retrospective or prospective. Given the submitter (Cryptych Pty Ltd) is based in North Sydney, NSW, Australia, and the submission is to the FDA, it's possible the study was conducted in Australia, but this is not confirmed. It was a "clinical study," which typically implies prospective data collection, but this is also not definitively stated as "prospective."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document mentions using the "clinical EEG Compumedics Grael EEG as a reference device and benchmark" for the clinical study. It does not mention experts establishing a "ground truth" in the traditional sense of labeling data (e.g., for diagnostic AI). The comparison was presumably based on the raw or processed signals from the two devices themselves.
Given the device "only acquires and displays physiological signals" and makes "no claims ... for the analysis of the acquired signals with respect to the accuracy, precision and reliability," the concept of "ground truth" for diagnostic accuracy is not applicable as per the device's intended use. The "ground truth" essentially refers to the output of the benchmark medical device.

4. Adjudication method for the test set:

Not applicable as the study involved comparing raw physiological signal acquisition between two devices, not interpretation or diagnosis requiring expert consensus/adjudication. The statement "both systems functioned identically in their ability to detect SSVEPs" suggests a direct comparison of the acquired signals or derived metrics.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed.
This device is not an AI-assisted diagnostic tool, but rather a device for acquiring and displaying physiological signals (VEPs and EEGs). Therefore, a study on human reader improvement with AI assistance is not relevant to its stated indications for use.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The non-clinical performance data (electrical safety, light safety, biocompatibility, cleaning, mechanical, firmware/software) represent standalone testing of the device's technical aspects and capabilities.
The clinical study was a comparison of signal acquisition between the Nurochek System and a reference EEG device; it wasn't an "algorithm-only" performance study in an AI context, but rather a verification of the physiological signal acquisition system.

7. The type of ground truth used:

The "ground truth" for the clinical study was the performance of a cleared predicate/reference medical device (Compumedics Grael EEG) in detecting SSVEPs. This falls under the category of "comparison to a reference standard medical device."
For the non-clinical tests, the "ground truth" was compliance with established international and national standards (e.g., IEC, ISO, ANSI, FDA guidances).

8. The sample size for the training set:

The document implies that the device "only acquires and displays physiological signals," and the software manages and displays these. It does not describe a machine learning model that would require a "training set" in the sense of supervised learning for classification or prediction. Therefore, the concept of a training set for an AI model is not applicable here. The software validation refers to standard software engineering verification and validation activities (IEC 62304), not AI model training.

9. How the ground truth for the training set was established:

As a training set for an AI model is not applicable, this question is not relevant.

Summary

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Cryptych Pty Ltd % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, Florida 33155-3708

Re: K200705

Trade/Device Name: Nurochek System Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: Class II Product Code: GWE, OMC Dated: April 21, 2020 Received: April 22, 2020

Dear Rafael Aguila:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely,

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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510(k) Number (if known)

K200705

Device Name

Nurochek System Indications for Use (Describe)

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

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

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510(k) SUMMARY

for

Nurochek System

510(k) Owner:Address:Phone and fax numbers:	Cryptych Pty LtdLevel 15, Suite 1502275 Alfred StreetNorth Sydney NSW 2060+61 299 595 820
Name of contact person:	Angela Roche
Trade Name:Common Name:Classification name:	Nurochek SystemVisual Evoked Photic StimulatorStimulator, Photic, Evoked Response
Regulation number:	882.1890
Product Code:Device Class:Manufacturer:Submitter:	GWE, OMCIICryptych Pty LtdCryptych Pty Ltd
Preparation Date:Predicate Devices:	March 05, 2020SightSaver Visual Stimulator by Anschel Technology INC.(K113785)X-Series System by Advanced Brain Monitoring (K131383)

DEVICE DESCRIPTION

The Nurochek System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display and store electroencephalograms (EEGs) during the generation of VEPs. The Nurochek System only acquires and displays physiological signals: no claims are being made for use as a diagnostic criterion or for the analysis of the acquired signals with respect to the accuracy, precision and reliability.

The Nurochek System operates on the principles of generating VEPs via photic simulation and acquiring the VEPs via EEG. Photic stimulation is provided through short-duration flashes of white light from multiple LEDs located in the front of the headset to direct the stimulus into the subject's eyes. The VEPs are acquired by an EEG comprising of a total of 5 electrode interfaces with hydrophilic foam cylinders saturated with saline solution to provide electrical contact to the subject's scalp. A Bluetooth receiver and

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Image /page/4/Picture/0 description: The image shows a 3D rendering of a hollow square or cube shape. The cube is constructed from four separate rectangular pieces that are joined at the corners. The color of the cube is a gradient, transitioning from a darker shade on the left to a lighter shade on the right, giving it a sense of depth and dimension. The cube appears to be floating or suspended in space, as there is no visible surface or background.

transmitter located within the Nurochek headset allows it to communicate with and be controlled by the Nurochek software application.

The Nurochek software application provides a graphical user interface which allows:

Collection of the subject details and consent,
Initiation of a study and tracking of patient information,
Acquisition and transmission of signals wirelessly to and from the headset.
Display of the contact quality of electrodes to the subject's scalp,
Recording, processing and display of EEG signals received from the headset, and ●
Manage previous EEG recordings of VEPs. ●

INTENDED USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES

The Nurochek System uses the same fundamental technology as its predicates for the generation of visualevoked potentials (VEPs) via photic stimulation, the capture of electroencephalograph (EEG) signals, wireless acquisition and software. The technologies used in the Nurochek System are used in the same manner as the predicate devices and do not raise new questions related to safety and effectiveness.

The Nurochek System is substantially equivalent to the legally marketed evoked-response photic stimulator and electroencephalograph (EEG) devices:

(1) Evoked-response photic stimulator technology: Device name: SightSaver Visual Stimulator 510(k) number: K113785 510(k) submitter: Anschel Technology Inc. Classification regulation: 882.1890 Product code: GWE

(2) Electroencephalograph technology: Device name: X-Series System 510(k) number: K131383 Model number: X10 / X24 510(k) submitter: Advanced Brain Monitoring Classification regulation: 882.1400 Product code: GWO, OMC
The Nurochek headset is worn by a subject and combines hardware, firmware and software to generate and acquire physiological signals, specifically, visual-evoked potentials (VEPs). The Nurochek operates on the principles of generating VEPs via photic activation and acquiring the VEPs via EEG.

Photic activation is achieved through short-duration flashes of white light from multiple LEDs located in the front of the headset (LED visual stimulator goggle) to direct the subject's eyes. This is technologically equivalent to the SightSaver Visual Stimulator (K1113785).

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Image /page/5/Picture/0 description: The image shows a 3D rendering of a hollow cube-like structure. The structure is composed of four rectangular segments that are joined at the corners to form an open, square frame. The segments are shaded in varying tones of gray, suggesting a light source from above. There is a small notch or cutout visible on the left side of the structure.

The VEP is acquired by an EEG located on the rear part of the headset that contacts the subject's scalp (the sensor). The resulting EEG signal is transmitted via Bluetooth to the Nurochek software application to be displayed and stored. These acquired signals are intended to be analyzed by a Physician. This is technologically equivalent to X-Series System (K131383).

The Nurochek System uses software that is technologically equivalent to the X-Series System to control the headset and display the acquired physiological signals. Like the X-Series System, the Nurochek System only acquires and displays the physiological signals and makes no claims in relation to diagnoses.

Table 1 provides a summary of the comparison of the key features between the Nurochek System and its predicates: SightSaver Visual Stimulator and the X-Series System.

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				Table 1: Comparison table of Nurochek with predicates devices

Device Name	Subject device: Nurochek System	Primary Predicate SightSaver VisualStimulator	Predicate X-Series System	Discussion
Manufacturer	Cryptych Pty Ltd	Anschel Technology Inc	Advanced Brain Monitoring	N/A
K Number	K	K113785	K131383	N/A
Indications forUse	The Nurochek System is intended forprescription use in healthcare facilitiesor clinical research environments forsubjects ages 14 years and older. TheNurochek System is indicated for thegeneration of visual evoked potentials(VEPs) and to acquire, transmit, displayand store electroencephalograms (EEGs)during the generation of VEPs. TheNurochek System only acquires anddisplays physiological signals: no claimsare being made for use as a diagnosticcriterion or for the analysis of theacquired signals with respect to theaccuracy, precision and reliability.	The SightSaver is an evoked responsephotic stimulator that is used to apply avisible light stimulus to a patient's eyesfor use in evoked response measurementsor for electroencephalogram (EEG)activation.The SightSaver Visual Stimulator isdesigned to be used in hospital andclinical settings by trained medicalpersonnel and is for prescription use only.	The X-Series System is intended forprescription use in the home, healthcarefacility, or clinical researchenvironment to acquire, transmit,display and store physiological signalsfrom patients ages 6 and older. The X-Series system requires operation by atrained technician. The X-SeriesSystem acquires, transmits, displaysand stores electroencephalogram(EEG), electrooculogram (EOG),electrocardiogram (ECG), and/orelectromyogram (EMG), andaccelerometer signals. The X-SeriesSystem only acquires and displaysphysiological signals, no claims arebeing made for analysis of the acquiredsignals with respect to the accuracy,precision and reliability.	EquivalentThe predicate devices generate avisual stimulus and acquire,transmit, displays and storeelectroencephalograms (EEGs)
Patient population	Ages 14 and older	Children and adults	Ages 6 or older	EquivalentPatient population of the NurochekSystem device is within the patientpopulation of the predicates.
Users	Licensed healthcare professionals	Trained medical personnel	Trained Technician	EquivalentAll devices require professionaloperators and are prescriptiononly.
Anatomical sitesfor EEG readings	Scalp	N/A (does not measure patient)	Scalp and Chest	EquivalentNurochek System's EEG sites arethe same (the scalp) as the X-Series System. The chest site is notrelevant as the Nurochek Systemdoes not utilize ECG technology.
Device Name	Subject device: Nurochek System	Primary Predicate SightSaver VisualStimulator	Predicate X-Series System	Discussion
Anatomical sitesfor visual stimulus	Periocular region of the patient's face	Periocular region of the patient's face	N/A (is not a visual stimulator)	EquivalentBoth the Nurochek and SightSavercontact the periocular region ofpatient's face to deliver the visualstimulus.
Prescription useor OTC	Prescription use only	Prescription use only	Prescription use only	Identical
Environment ofUse	Healthcare facilityClinical Research Environment	HospitalClinical settings	HomeHealthcare facilityClinical Research Environment	EquivalentNurochek System and bothpredicates are used in a healthcarefacility.
Cleaning	Cleaned and disinfected by rubbing withdisinfectant wipes	N/A (the device is disposable)	Cleaned and disinfected by rubbingisopropyl alcohol	EquivalentThe Nurochek headset is cleanedand disinfected to a higherstandard. A higher standard is useddue to the design of Nurochek'sheadset. The Nurochek headsetcontains an anterior visor while theX-series System does not. As testswere performed to demonstratedthat cleaning methods areappropriate for ensuring theNurochek headset is clean betweenuses they are consideredequivalent.
		Technical specifications
User Interface	User control, visual indicators	N/A (does not contain any controls)	User control, visual indicators	EquivalentNurochek System has same userinterface features as X-SeriesSystem.
Wireless datatransfer	Bluetooth	N/A (does not transfer data)	Bluetooth	EquivalentNurochek uses the sametechnology as X-Series System.
Signals Acquired	Scalp EEG	N/A (does not acquire signals)	Scalp EEG3-D actigraphy	EquivalentNurochek System only utilizesscalp EEG technology and doesnot utilize 3-D actigraphy nor theoptional channels of the X-Series
Device Name	Subject device: Nurochek System	Primary Predicate SightSaver VisualStimulator	Predicate X-Series System	Discussion
			Optional channelsECG/EEG/EOG/EMG	System. Therefore, the othersignals are not relevant for theNurochek System.
Power Supply	3.7V, 800 mAH Li-Ion battery	Externally powered by trigger device.	2 to 4 240 mAH 3.7V, 240 mAH Li-Ionbatteries	No Significant DifferencesBoth Nurochek System and X-series System use rechargeable3.7V lithium-ion batteries. Thedifference in charge capacity andnumber of batteries, which onlydictates the length of use.The SightSaver is to be connectedto a separate control device whichsupplies the power.
Operating time	After full charge, unit is capable of atleast 30 complete tests (30 minutes)	N/A (controlled by external trigger)	Monitoring days after charge hours ofuse:0-4 days: 16 to 17 hours5-10 days: 14 to 15 hours.	No significant differencesThe Nurochek System is indicatedfor short-term use i.e. 2 sets of 30second tests completedconsecutively.The X-Series System is indicatedfor long-term monitoring over alarge period of time.
Battery Charging	Via USB cable from a wall charger	N/A (does not contain battery)	Via JED Connector connected to theUSB port or USB wall charger	EquivalentThe charging mechanisms betweenthe Nurochek System and X-SeriesSystem are the same, differingonly in the connector style whichdoes not affect safety of NurochekSystem.
Typical ChargingTime	Typical: 0.5- 3 hours	N/A (does not contain battery)	Typical: 0.5-5 hours.	No significant differenceThe charging time for a full chargefor the Nurochek device is lessthan the X-Series System, allowingit to be used more frequently.
Photic Stimulation Technology
Mode ofOperation	Photic stimulator positioned on theperiocular region of the patient's face toexpose the eyes to LED light in order togenerate a physiological response.	Photic stimulator positioned on theperiocular region of the patient's face toexpose the eyes to LED light in order togenerate a physiological response.	N/A (does not contain photicstimulation technology)	EquivalentThe Nurochek uses the same visualstimulator LED technology as the
Device Name	Subject device: Nurochek System	Primary Predicate SightSaver VisualStimulator	Predicate X-Series System	Discussion
Light source	LED	LED	N/A (does not contain photicstimulation technology)	EquivalentThe Nurochek System uses thesame technology of light (Light-emitting diodes - LED) as theSightSaver device.
Flash Rate	15Hz fixed	Typically 0.5-1.0Hz, up to 100Hz	N/A (does not contain photicstimulation technology)	EquivalentThe SightSaver's flash ratedepends on the external trigger.There is no limiting mechanism onthe SightSaver itself. For example,when used with the Nicolet VikingEDX (K112052), the flash rate canbe set to 0.1-100Hz.Flash rate of the Nurochek headsetlight stimulus is fixed to 15Hz,which is within the capabilities ofthe SightSaver.
EEG Technology
ElectrodesMaterial	Hydrophilic polyurethane foam on goldplated copper	N/A (does not contain EEG technology)	Ag/AgCl	No significant differenceBoth electrodes achieve the samefunction. Material difference hasbeen tested and does not affectsafety and efficacy of NurochekSystem.
Definition	3 EEG scalp channels	N/A (does not contain EEG technology)	Up to 20 EEG scalp channels	EquivalentThe Nurochek System uses asubset of the channels of thepredicate device. The additionalnumber of channels on thepredicate device will go unusedwhen used for the detection ofVEPs: this is because only 3electrode sites (01, O2 and Oz)correspond to the visual cortex.
Signal processingtechniques	Sampling rate: 250 s/s	N/A (does not contain EEG technology)	Sampling rate: 256 s/s0.1 Hz High Pass, hardware	Equivalent
Device Name	Subject device: Nurochek System	Primary Predicate SightSaver VisualStimulator	Predicate X-Series System	Discussion
	Digital decimation filters		100 Hz Low Pass, hardware	A sampling rate difference onlydictates the maximum frequencythat can be interpreted.Different filtering systems are usedbut both achieve the same goal notaffecting the safety andeffectiveness of Nurochek System.
Accuracy,variance anderror ofmeasurements, incomparison tostandardtechniques ofmeasuringidenticalphysiologicvariables.	Sampling rate: 250 HzDynamic range: +/- 187,500 μVResolution: 0.02μVPeak to peak noise: 1.97μV (typical)110 dB Common rejection ratioInput impedance: 1GOhm	N/A (does not contain EEG technology)	Sampling rate: 256 HzDynamic range: +/- 1000μVResolution: 0.03μVPeak to peak noise: 3.7μV (typical)110 dB Common Mode Rejection Ratio(typically)Input impedance: 100GOhm	EquivalentAa above, a sampling ratedifference only dictates themaximum frequency that can beinterpreted.The dynamic range on theNurochek System is larger (andtherefore superior) than the X-Series System.The dynamic range of theNurochek exceeds that of the X-Series system. A higher dynamicrange means a wider range ofvoltages may be interpretedwithout saturation.Nurochek System exceeds theresolution performance of the X-Series System. A lower resolutionnumber means the NurochekSystem can resolve smallerdifferences in the signal, making itmore accurateThe Nurochek System has a lowerpeak-to-peak noise of the X-SeriesSystem. A lower peak-to-peaknoise level means that the noisewill have less of an effect on thesystem.Both devices have the samecommon mode rejection ratio.
Device Name	Subject device: Nurochek System	Primary Predicate SightSaver VisualStimulator	Predicate X-Series System	Discussion
				International Organisation ofSocieties for ElectrophysiologicalTechnology (OSET) recommendsat least 10 MOhm, which bothdevices exceed substantially.
Impedance Check	Yes	N/A (does not contain EEG technology)	Yes	EquivalentThe Nurochek System and the X-Series System both have animpedance check.
		Safety and Performance
Electrical	IEC 60601-1:2013IEC 60601-2-40	Unknown	IEC 60601-2-26:2002IEC 60601-1-11: 2010IEC 60601-1:1998+A1: 1991+A2: 1995	EquivalentThe Nurochek System uses moreup-to-date standards.IEC 60601-2-26 is not used as IEC60601-2-40 is more suitable fordevices with evoked responseequipment.IEC 60601-1-11:2010 is not usedas it applies to home use devicesonly.
ElectromagneticCompatibility	IEC 60601-1-2:2014	Unknown	IEC 60601-1-2: 2007	EquivalentThe Nurochek System uses moreup-to-date standards.
Light Safety	ISO 15004:2ANSI Z80.36	ISO 15004:2	N/A (no visual stimulus)	EquivalentThe Nurochek System uses thesame standard as the predicate, aswell as an additional FDArecognized standard for lightsafety.
Software	FDA Guidance for the Content ofPremarket Submission for SoftwareContained in Medical DevicesDocument (May 11, 2005)FDA Guidance for Content of PremarketSubmission for Management ofCybersecurity of Medical Devices	N/A (does not contain software)	FDA Guidance for the Content ofPremarket Submission for SoftwareContained in Medical DevicesDocument (May 11, 2005)	EquivalentThe Nurochek System uses thesame FDA guidance as thepredicate, as well as an additionalFDA guidance for cybersecurity.
Device Name	Subject device: Nurochek System	Primary Predicate SightSaver Visual Stimulator	Predicate X-Series System	Discussion
Usability andHuman Factors	IEC 62366FDA Guidance on Applying HumanFactors and Usability Engineering toMedical devices	Unknown	Unknown	N/A
Cleaning	AAMI TIR 12:2010AAMI TIR 30:2011Guidance for Industry and FDA Staff -Reprocessing Medical Devices in HealthCare Settings: Validation Methods andLabeling. 2015	N/A	AAMI TIR 12-94AAMI TIR 30: 2003	EquivalentSame methods; more up-to-datestandards for reprocessing methodvalidation.An additional FDA guidance wasused.
Biocompatibility	ISO 10993-5 – CytotoxicityISO 10993-10 - SensitizationISO 10993-10 - Irritation	Unknown	ISO 10993-5 – CytotoxicityISO 10993-10 - SensitizationISO 10993-10 - Irritation	EquivalentThe Nurochek System uses thesame standards forbiocompatibility as the X-SeriesSystem.

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Image /page/9/Picture/0 description: The image shows a 3D rendering of a square frame. The frame is composed of thick, gray material and has a cutout on the lower left corner. The perspective is isometric, providing a clear view of the frame's structure and depth.

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Image /page/10/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be open in the center, forming a hollow square. The color scheme is primarily gray, with darker shades on the sides and a lighter shade on the top and bottom. There is a small notch or cutout on the lower left side of the structure.

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Image /page/11/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be made of a dark gray material and has an opening on one side. The opening is a rectangular notch cut out of the side of the square. The structure has a simple, geometric design and appears to be a hollow frame.

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Image /page/12/Picture/0 description: The image shows a 3D rendering of a square frame. The frame is gray and has a thick border. There is a small notch cut out of the bottom left corner of the frame. The frame appears to be floating in space.

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Image /page/13/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be made of a dark gray material and has a hollow center. There is a small notch or cutout on one of the corners of the square. The structure is viewed from an isometric perspective, giving a sense of depth and dimension.

NON-CLINICAL PERFORMANCE DATA

The Nurochek was developed and manufactured with risk management and safety testing, including electrical safety, biological safety, performance and software testing. This testing has provided assurance of safety and effectiveness within the scope of its intended use.

ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC)

Electrical safety and EMC testing were conducted on the Nurochek consisting of the headset, firmware and software.

Electrical safety and performance testing were conducted as per IEC 60601-1 (including collateral IEC 60601-1-2 for EMC testing and particular standard IEC 60601-2-40). Compliance to IEC 60601-2-40:2002 -'Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment' was also conducted.

All test results demonstrated compliance of the Nurochek to standards for electro-medical equipment.

LIGHT SAFETY

Light safety testing was conducted as per ISO 15004-2:2007 and ANSIZ80.36-2016. Testing to both standards classified the Nurochek Headset as a Group Instrument. Both standards define a Group 1 instrument as: ophthalmic instruments for which no potential light hazard exists. Therefore, use of the Nurochek system as per the IFU will not lead to patient or user harm due to optical radiation.

BIOCOMPATIBILITY

Biocompatibility was assessed following FDA Guidance "Use of International Standard ISO10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Per Table 1 of the guidance, the Nurochek headset is a surface device with limited contact (Category A, less than 24 hours contact) and thus cytotoxicity, sensitization, and irritation reactivity tests were selected. Test methods were performed as per the relevant ISO 10993 standards series for Biological Evaluation of Medical Devices. These standards include cytotoxicity (ISO 10993-5), skin irritation and sensitization (ISO 10993-10). All contacting parts were evaluated, including the foam cylinders and strap components. Results of biocompatibility testing demonstrate that materials of the Nurochek System in contact with the patient are biocompatible.

CLEANING

The Nurochek headset cleaning and disinfection procedures have been validated in compliance with the FDA Guidance Document "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling". Testing was performed in accordance with recommended evaluations according to AAMI TIR30 and AAMI TIR12. All tests passed and demonstrated that the cleaning methods are appropriate for ensuring the Nurochek System is clean between uses.

MECHANICAL TESTING

Cyclic testing was performed to test the durability of the mechanical components of the Nurochek headset. The testing was to ensure that the device will meet its required use lifetime. This cyclic testing includes simulating the fitting, lifting and removal of the Nurochek headset on a patient's head.

Drop, impact and push tests as per IEC 60601-1 Ed. 3.1. were also performed to ensure the Nurochek headset is sufficiently resilient against foreseeable misuse.

All test passed and demonstrated compliance of the Nurochek System to IEC 60601-1 criteria.

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Image /page/14/Picture/0 description: The image shows a 3D rendering of a square-shaped structure. The structure appears to be made of four separate pieces that are joined together to form the square. The pieces are gray in color and have a smooth, matte finish. The structure is viewed from an isometric perspective, with the top and right sides visible. The background is white.

FIRMWARE AND SOFTWARE

The firmware in the Nurochek headset and the Nurochek software have been thoroughly tested through verification and validation testing, including software validation as recommended by FDA's "Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software in Medical Devices", and according to IEC 62304.

The results of the verification and validation activities performed demonstrate the software meets requirements for safety, function and intended use.

CLINICAL STUDIES

A clinical study was performed to evaluate the functionality of the Nurochek System - headset, firmware and software. The study used the clinical EEG Compumedics Grael EEG as a reference device and benchmark. Compumedics Grael EEG is cleared by FDA under K093223. however, is not a predicate of this 510(k) submission. Data from 20 participants were compared to the Compumedics Grael EEG in its performance to detect steady-state visual-evoked potentials (SSVEPs). Participants were evaluated on the clinical EEG and the investigational device with a common visual stimulus shared between them.

All tests were performed successfully with no adverse events. The study concluded that both systems functioned identically in their ability to detect SSVEPs.

CONCLUSION

Cryptych considers the Nurochek System to be as safe and effective as the predicate devices and, therefore, substantially equivalent. The Nurochek System does not introduce any new questions concerning safety or efficacy. As demonstrated by the results from the non-clinical tests performed, the Nurochek System is safe and effective and meets the pre-defined design and performance acceptance criteria. The Nurochek System and its predicates, the SightSaver Visual Stimulator and X-Series System, have the same intended use and similar indications, technological characteristics and principles of operation. Therefore, the Nurochek System is substantially equivalent to the SightSaver Visual Stimulator and the X-Series System.

Regulation Number and Section

§ 882.1890 Evoked response photic stimulator.

(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).