The system is intended to statistically evaluate brain activity reflected in a broad band of high-gamma frequencies in the human electroencephalogram (EEG). These measures should always be interpreted in conjunction with review of the original EEG waveform.

cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.Hlamp.

Device Description

cortiQ PRO is a system that uses g.Hlamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the highgamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.

cortiQ PRO reads in the digital data from the g.Hlamp amplification system (1200 Hz sampling frequency, up to 256 channels) via USB into the processing computer. The data is acquired without bandpass and notch filtering and without bipolar derivation. The software allows one to select the channels that should be acquired and stores the raw data together with header information for later off-line analysis.

Raw data is visualized on a raw data scope to inspect the data quality. The scope allows scaling of the data in amplitude and time. Furthermore the software allows scaling of all the channels to the same amplitude to make the interpretation easier. In the scope, it is possible to select a new ground and reference channel and to exclude a channel from the processing (if the data quality is bad). The raw data scope filters the data with a high-pass filter to remove DC-offsets for optimal visualization.

cortiQ PRO allows the operator to select an experimental paradigm that instructs the patient to perform certain tasks. The instructions are presented on a patient computer screen or are given via a speaker. The user can select, start and terminate the experimental paradigm. Additionally, the number of repetitions can be selected. A dedicated paradigm editor creates new paradigm files or modifies existing paradigms.

The rapid cortical mapping functions perform a common average reference (CAR) of all the active channels to remove common mode signals such as power line interference. Then the module calculates the high-gamma activity in certain frequency ranges for the different tasks and compares the high-gamma activity to those of another task according to the selected paradigm. Then a statistical analysis is performed and significant activation is plotted as bubble on the defined electrode position in order to identify important regions. When the mapping has ended, cortiQ PRO automatically generates a mapping report containing the montage definition, the paradigm definition, and the mapping results. This report is stored as pdf and can be printed. The mapping result is also stored for later analysis.

cortiQ PRO allows the operator to define montage definition files in the montage creator by loading predefined electrode grids from different manufacturers. Each grid has a certain number of channels. The montage creator allows the operator to assign a patient's name and date of birth, and a montage name to each file. Furthermore, it allows the operator to assign a grid name to each electrode grid. The grids can be placed on different background images to make the location interpretation easier. Electrodes from a grid can be disabled, used as reference or as ground electrodes. The grids can be resized or rotated. The montage creator assigns also the electrode grids automatically to the amplifier inputs channels and creates a report with the channel definition. The results can be stored to be modified later. The report is stored as pdf and can be printed.

cortiQ PRO comes with an installs the software under Windows. A hardlock is required to start the mapping software.

The mapping system comes with Instructions for use and a training program.

AI/ML Overview

The provided 510(k) summary for the cortiQ PRO device does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format as typically found in comprehensive clinical or performance studies. Instead, it offers a general statement about performance testing.

Here's an attempt to extract and present the information based on the available text:

Acceptance Criteria and Device Performance

The documentation states: "The testing showed that the difference in gamma activity can be correctly mapped to correct electrode channels." This is the primary functional performance claim related to the core function of the device in evaluating high-gamma brain activity. However, specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, or minimum R2 values) are not explicitly provided in the given text, nor are specific reported device performance metrics in a tabular format.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred)

Acceptance Criteria (Inferred from Claims)	Reported Device Performance
Ability to correctly map differences in high-gamma brain activity to correct electrode channels (based on task-related differences for real ECoG data and amplitude differences for artificial test data during "pause" vs. "action" intervals).	"The testing showed that the difference in gamma activity can be correctly mapped to correct electrode channels."
The system cortiQ PRO works like the predicate devices (implied equivalence in safety and effectiveness regarding signal acquisition and processing capabilities, particularly compared to NeuroGuide Analysis System for statistical evaluation and g.Hlamp for signal acquisition, as detailed in Tables II and III).	"The testing showed that the system cortiQ PRO works like the predicate devices."
Usability requirements are met at an acceptable risk level by the intended user group.	"The results of the usability testing demonstrate that the cortiQ PRO system (including the control software) meets all specified usability requirements at an acceptable risk level."
Compliance with safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-26, ISO 14971, IEC 62304, IEC 62366) and medical safety features (medical grade power supply, isolated inputs/outputs, isolated applied parts).	"In cortiQ PRO the medical safety is realized by using the g.Hlamp which is powered by a medical grade power supply unit and provides isolated input and outputs for communication as well as appropriate isolated applied parts for the treatment."

Study Details

The provided text describes performance testing, but not a formal clinical study with detailed methodology typically associated with "acceptance criteria" and "device performance" in a quantitative sense.

Sample size used for the test set and the data provenance:
- Test Set: "several real electrocorticographic (ECoG) and artificial test signals." No specific number is given for "several."
- Data Provenance: Not specified, but "real electrocorticographic (ECoG) data" would likely be from human subjects, potentially clinical. "Artificial test signals" are generated. Whether these ECoG data were prospective or retrospective is not stated. Country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth for artificial signals is inherent in their design. For real ECoG data, how "task-related differences" were confirmed as ground truth is not detailed, nor is the involvement of experts in establishing this ground truth.
Adjudication method for the test set:
- This information is not provided. Given the nature of the testing described (mapping gamma activity), it's unclear if an adjudication method between multiple readers/interpreters was necessary or employed.
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The cortiQ PRO is described as a system for statistical evaluation and visualization of brain activity, intended to be interpreted in conjunction with review of the original EEG waveform and dependent upon the judgement of the clinician. This implies human-in-the-loop, but without a formal MRMC study evaluating improvement with AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The description of the testing ("The testing showed that the difference in gamma activity can be correctly mapped...") suggests performance validation of the algorithm's ability to identify and map differences in gamma activity. This can be interpreted as a form of standalone performance evaluation for its core function. However, the device's indications for use emphasize that measures "should always be interpreted in conjunction with review of the original EEG waveform," implying it is not intended for fully standalone diagnostic interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For artificial test signals: The ground truth is the inherent design of the signals, where "lower amplitude in the task baseline interval" and "higher amplitude in the action interval" on specific channels define the expected difference.
- For real electrocorticographic (ECoG) data: The ground truth relies on "task-related differences in the high-gamma frequency band." How these differences are definitively established as "ground truth" (e.g., through other modalities, expert consensus, surgical outcomes) is not explicitly stated.
The sample size for the training set:
- This information is not provided. The document describes performance testing but does not detail the development or training of the algorithm that identifies "high-gamma broad band brain activity."
How the ground truth for the training set was established:
- This information is not provided as details about a training set are absent.

Summary

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

g.tec medical engineering GmbH Christoph Guger CEO Sierningerstrasse 14 4521 Schiedlberg, Austria

Re: K191432

Trade/Device Name: cortiQ PRO Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLU, GWL, OLT Dated: December 18, 2019 Received: December 23, 2019

Dear Christoph Guger:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

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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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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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Indications for Use

510(k) Number (if known) K191432

Device Name cortiQ PRO

Indications for Use (Describe)

cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.Hlamp.

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

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).

807.92(a)(1)

	Submitter Information
g.tec medical engineeringGmbH Sierningstrasse 144521 SchiedlbergAustria
Phone:Fax:Contact Person:Date:	++43 (7251) 22240-12++43 (7251) 22240-39Christoph GugerMay 24, 2019
807.92(a)(2)
Trade Name:	cortiQ PRO
Common Name:	Normalizing quantitative electroencephalograph softwareAmplifier, physiological signal
Classification name:	Electroencephalograph21 CFR section 882.1400
Product Code:	OLU, OLT, GWL
807.92(a)(3)	Predicate Device(s)
K#Trade/Device NameRegulation NumberRegulation NameRegulatory ClassProduct CodeDateReceivedAspect	K041263 (primary predicate)NeuroGuide Analysis System21 CFR 882.1400ElectroencephalographClass IIOLUJuly 20,2004July 22,2004Signal analysis and statistical processingof data	K123255 (secondary predicate)g.Hlamp21 CFR 882.1835Physiological signal amplifierClass IIGWLOctober 10, 2012October 18, 2012Recording of EEG data and providing it tothe signal processing via an application

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807.92(a)(4)

Device Description

cortiQ PRO comes with an installs the software under Windows. A hardlock is required to start the mapping software.

The mapping system comes with Instructions for use and a training program.

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807.92(1)(5)

Intended Use(s)

cortiQ PRO is intended for the evaluation of intracranial EEG recorded with the g.HIamp.

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g.tec medical engineering GmbH

807.92(a)(6)

Technological Characteristics

System relevant comparison characteristics between cortiQ PRO system and the two predicates g.Hlamp and NeuroGuide Analysis System: Table I

Table 1	Item	cortiQ PRO	g.HlampK123255	NeuroGuide Analysis System(NeuroGuide Base, NeuroStat,Neurofeedback) K041263	Comment
1.	Intended Use	The system is intended to statistically evaluate brainactivity reflected in a broad band of high-gammafrequencies in the human electroencephalogram (EEG).These measures should always be interpreted inconjunction with review of the original EEGwaveform.cortiQ PRO is intended for the evaluation ofintracranial EEG recorded with the g.Hlamp.	The g.Hlamp amplifier is intended to be used toacquire biopotentials and transmit them to a computervia the USB port connection. These biopotentialsinclude for example electroencephalogram (EEG),electromyogram (EMG), electrooculogram (EOG),and electrocardiogram (ECG).	For clinical use the NeuroGuide Analysissystem is to be used by qualified medical orclinical professionals for the statisticalevaluation of the humanelectroencephalogram (EEG)	cortiQ PRO combinesboth intended uses andlimits it to the statisticalevaluation of brainactivity and is thereforeequivalent in safety andeffectiveness.
2.	Contraindication /Limitations	• The device must not be used directly on the heart.• The device must not be used for the determination ofbrain death. Additional examinations are needed fordiagnosis and no diagnosis may be done only basedon using this device.• The device must not be used during defibrillation.Remove all electrodes and probes from the patientbefore defibrillation, otherwise the operator mayreceive an electrical shock or the connectedinstrument may be damaged.• The device must not be used in humans with pace-makers or electrical stimulators• Must not be used for electromyography (EMG),electrooculography(EOG), electrocardiography(ECG)• The device must be used either by a medical expert,such as a medical doctor with expertise in the field ofneurology or neurosurgery, or by a medical technicalexpert such as neuroscience specialists. A user isonly eligible to operate the device after completeddevice training.• The device must not be used when a patient is non-compliant to planned procedures due to age,cognitive function, or cognitive development stage.Such procedures might depend on the activecooperation of the patient and/or a sufficientlydeveloped brain, and/or other aspects. Generally	• The device must not be used directly on the heart.• The device must not be used for the determinationof brain death. Additional examinations are neededfor diagnosis and no diagnosis may be done onlybased on using this device.• The device is not protected against the effect ofcardiac defibrillator discharge• The device must not be used in humans with pace-makers or electrical stimulators	Only for qualified medical clinicalprofessionals.	cortiQ PRO showsadditional limitationsand contraindicationsbut is equivalent insafety andeffectiveness.

		patients that are eligible for brain surgery in generaland the individual type of surgery (e.g. epilepsy,tumor, or similar) in particular are also eligible forthe usage of this device. In the individual case theresponsible surgeon has to decide upon theprocedures and the usage of the device.• The device must not be used for diagnosis withoutvalidation by another modality.The device must not be used for patient monitoring.
3.	System components	• g.Hlamp including:- amplifier- AC/DC adapter- USB cable- 1-4 electrode connector boxes.- driver software• personal computer inclusive speakers and monitor• additional monitor including USB cable• cortiQ PRO software• hardlock USB dongle	• g.Hlamp including:- amplifier- AC/DC adapter- USB cable- 1-4 electrode connector boxes.- driver software	• software• personal computer• amplifier• additional monitor	cortiQ PRO includesalso a processingcomputer and screenfor paradigmpresentation, but isequivalent in safety andeffectiveness.
4.	Safety standards	IEC60601-1IEC60601-1-2IEC60601-2-26ISO 14971IEC 62304IEC 62366	IEC60601-1IEC60601-1-2IEC60601-2-26IEC60601-2-40MDD 93/42/EECIEC60601-1-4ISO 14971IEC 62304	No remark in 510k summary or instruction foruse	cortiQ PRO covers therequired standards toensure equivalence insafety andeffectiveness.
5	Dimensions	• standard personal computer• g.Hlamp:197 (L) x 197 (W) x 90 (H) mm• additional monitor	197 (L) x 197 (W) x 90 (H) mm	• personal computer• amplifier• additional monitor	cortiQ PRO isequivalent in safety andeffectiveness.
6.	Weight	• g.Hlamp 1.875kg• personal computer• additional monitor	1.875kg	• personal computer• amplifier• additional monitor	cortiQ PRO isequivalent in safety andeffectiveness.
7.	Software/ Firmware	Firmware resident on g.Hlamp, g.Hlamp API onpersonal computer, cortiQ software on personalcomputer.	Firmware resident on g.Hlamp, g.Hlamp API onpersonal computer,	Only software on personal computer	cortiQ PRO uses bothresident firmware andsoftware componentsbut is equivalent insafety andeffectiveness.
8	User interface	GUI	g.Hlamp API	GUI	cortiQ PRO uses agraphical user interface(GUI) and is thereforeequivalent in safety andeffectiveness.

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cortiQ PRO 510(k) Premarket Notification

g.tec medical engineering GmbH

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Comparison between cortiQ PRO and g.HIamp characteristics for data acquisition:

Table II
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	Item	cortiQ PRO	g.HlampK123255	Comment
9.	EEG/Polygraphicchannels	80-256 monopolar	80-256 monopolar	Same as predicate.
10.	DC channel	80-256	80-256	Same as predicate.
11.	Full scale inputrange	± 250 mV	± 250 mV	Same as predicate.
12.	A/D conversion	24 Bit SAR	24 Bit SAR	Same as predicate.
13.	Sampling rate	User selectable (256, ... up to 38400Hz/channel) predefined in setting1200 Hz	User selectable (256, ... up to 38400Hz/channel)	Preselected for cortiQPRO system butequivalent in safety andeffectiveness.
14.	Noise	<0.5 µV RMS, <2 µV peak-to-peak	<0.5 µV RMS, <2 µV peak-to-peak	Same as predicate.
15.	Power Supply	External IEC 601-1 mains adapter, 5VDC	External IEC 601-1 mains adapter, 5VDC	Same as predicate.
16.	Internal Storage	N/AOptional on PC HDD	N/A	cortiQ PRO allowssignal data storage onthe controlling computerbut is equivalent insafety and effectiveness.
17.	Amplifier-PCInterface	USB	USB	Same as predicate.
18.	Other Interfaces	Power on LED	Power on LED	Same as predicate.
19.	Use standard sensorsand electrodes	Yes (electrodes and sensors are notincluded with the amplifier)	Yes (electrodes and sensors are notincluded with the amplifier)	Same as predicate.
20.	Isolation	Opto coupler, patient isolation CFtype	Opto coupler, patient isolation CFtype	Same as predicate.
21.	Digitalinputs/outputs	16 inputs, all patient separated, nooutputs	16 inputs, all patient separated, nooutputs	Same as predicate.
22.	Patient connectionand device inputs	80-256 monopolar inputs - 80-256plugs4 ground inputs - 4 plugsUSB - 1 connectorDIGITAL IN - 2 connectorsHOLD - 1 connector1 x USB - screen1 x USB - hardlock	80-256 monopolar inputs - 80-256plugs4 ground inputs - 4 plugsUSB - 1 connectorDIGITAL IN - 2 connectorsHOLD - 1 connector	Additional connectors ofpersonal computer in thecortiQ PRO system butequivalent in safety andeffectiveness.
23.	Type of applied part	CF	CF	Same as predicate.
24.	Impedancemeasurement	Possible on hardware but disable insoftware.	Performed with 10 Hz	No impedancemeasurement in cortiQPRO but equivalent insafety and effectiveness.
25.	Input impedance	>100 MOhm	>100 MOhm	Same as predicate.
26.	Filters in theamplifier	DC up to 2000 Hz (depending onsampling frequency). DC used inpreset.	DC up to 2000 Hz (depending onsampling frequency)	cortiQ PRO records datawithout appliedhardware filter but isequivalent in safety andeffectiveness.
27.	Frequency response	Linear between 0.1 and 170 Hz	Linear between 0.1 and 100 Hz	Same as predicate.

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Comparison between cortiQ PRO and NeuroStat characteristics for statistical analysis: Table III

	Item	cortiQ PRO	NeuroGuide Analysis System(NeuroStat)K 041263	Comment
28.	Signal processing	Real-time	Post-hoc	cortiQ PRO performs theanalysis in real-time but isequivalent in safety andeffectiveness.
29.	Signal source	g.Hlamp API	Imported from a data-file	The cortiQ PRO directly getsdata from the g.Hlamp API soit increases the effectivenessbut is equivalent in safety.
30.	Band powerestimation	Auto regressive model for powerspectrum (AR)	Fast Fourier transformation (FFT)for power spectrum	cortiQ PRO uses an AR modelfor optimized data processingbut is equivalent in safety andeffectiveness.
31.	Statistical analysis	Parametric statistical test with R2output metric	ANOVA (Analysis of variances)	cortiQ PRO uses R2 values forstatistical analysis andNeuroStat ANOVA but isequivalent in safety andeffectiveness.
32.	Analysis output	R2 value for each channel	p-value for each channel	cortiQ PRO uses R2 values asoutput of analysis andNeuroStat p-values but isequivalent in safety andeffectiveness.
33.	Visualization	Topographical mapping	Topographical mapping	Same as predicate
34.	Comparison of datasegments	Comparison of baseline with taskrelated data	Pre- and post-treatment data	cortiQ PRO performs thecomparison within the samemeasurement but is safer andequivalentin effectiveness.
35.	Type of comparison	In-person comparison	In-person comparison, or groupcomparison	cortiQ PRO only provides in-person comparison but isequivalent in safety andeffectiveness.
36.	Acceptance or rejectof the results	Dependent upon the judgementof the clinician	Dependent upon the judgement ofthe clinician	Same as predicate.

Comparison between cortiQ PRO and Neurofeedback add-on characteristics for patient interaction: Table IV

	Item	cortiQ PRO	NeuroGuide Analysis System(Neurofeedback)K 041263	Comment
37.	Visual feedback orinteraction withpatient	via additional monitor andparadigm presenter	via additional monitor and paradigmpresenter	Same as predicate
38.	Auditory feedback orinteraction withpatient	via personal computer speakersand player	via personal computer speakers andplayer	Same as predicate
39.	Session setup	Paradigm editor for sessionsetup.	Editor for session setup.	Same as predicate
40.	Number of runs	Freely adjustable	Freely adjustable	Same as predicate
41.	Run duration	Freely adjustable with limitationwarning.	Freely adjustable	cortiQ PRO informs user whenlimits are underwent but isequivalent in safety andeffectiveness.

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807.92(b)(1)

cortiQ PRO was subject to safety and performance testing procedures. cortiQ PRO was tested with several real electrocorticographic (ECoG) and artificial test signals. While ECoG data contain task-related differences in the high-gamma frequency band, the artificial test data consists of dedicated noisy sinusoidal waveforms in the gamma range with lower amplitude in the task baseline interval (represents subject at pause) and higher amplitude in the action interval (represents subject doing a task) on all channels. The testing showed that the difference in gamma activity can be correctly mapped to correct electrode channels.

The testing showed that the system cortiQ PRO works like the predicate devices. In cortiQ PRO the medical safety is realized by using the g.Hlamp which is powered by a medical grade power supply unit and provides isolated input and outputs for communication as well as appropriate isolated applied parts for the treatment.

Usability validation testing was performed in N=15 participants from the intended user group (neuroscientists, neurosurgeons, and neurologists). Participants in the usability validation testing performed simulated use testing following the specified device training program. The results of the usability testing demonstrate that the cortiO PRO system (including the control software) meets all specified usability requirements at an acceptable risk level.

Testing of the cortiQ PRO was performed in compliance with the g.tec design control process.

807.92(b)(2)

Not applicable

807.92(b)(3)

Based on the comparison in the technical comparison chart above and confirmed by verification/validation testing in compliance with design control requirements, cortiQ PRO was shown to be equivalent in safety and effectiveness to the predicate devices.

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).