The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.

Device Description

The Okti is a physiological data acquisition device intended for conducting EEG studies. It is used in conjunction with a PC running Compumedics Profusion EEG software. Power is provided by either an internal Lithium-Ion battery or a POE 100BASE-TX network connection. Physically, the Okti comprises a base unit housing the battery and digital electronic circuits. A changeable module connects to the base unit and houses the analogue circuity and electrode connectors providing options for 32, 64 or 128 referential, or single ended, channels primarily intended for EEG. Each module includes several differential inputs for electrode-based signals such as ECG, EMG or EOG. All these inputs are class CF for patient safety. Patient physiological data is digitised using multiple 24-bit ADCs and filtered using fixed point FIR filters implemented internally to an FPGA located in the analogue module. The data is transferred to a generalpurpose processor in the base unit over a synchronous serial link. From there the patient data may be saved to a device internal SD card or sent to a remote PC over an Ethernet or Wi-Fi LAN connection. A Bluetooth interface is also included for connection to external devices such as an oximeter. The Okti system is available in Okti32, Okti64, or Okti128. These differ only in channel number.

AI/ML Overview

The provided text describes a medical device, Okti, which is an Electroencephalograph (EEG) system. The document is a 510(k) premarket notification to the FDA, asserting the substantial equivalence of Okti to a previously cleared predicate device, the Grael EEG system.

While the document extensively covers the electrical, mechanical, and performance specifications of the Okti device and compares it to its predicate, it does not describe a study involving AI assistance, human readers, or the establishment of ground truth by multiple experts for diagnostic performance evaluation, as would be expected for a typical AI/ML-driven device. The device described here is an EEG recording device, not an AI or diagnostic algorithm. Therefore, many of the requested criteria related to AI/ML device performance evaluation (e.g., sample size for test/training sets, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth for diagnostic accuracy) are not applicable or not provided in this specific document.

The "performance data" summary relates to the technical validation of the device's ability to accurately record and process physiological signals, ensuring electrical safety, electromagnetic compatibility, and adherence to established EEG standards. It's about the quality of the signal acquisition, not the diagnostic accuracy of an AI interpreting the signals or a human interpreting with AI assistance.

Based on the provided text, here's what can be extracted regarding acceptance criteria and device performance, focusing on the device's technical performance rather than diagnostic AI performance:

Acceptance Criteria and Reported Device Performance (Technical Validation)

The document focuses on demonstrating substantial equivalence to a predicate device (Grael EEG) by comparing technical, electrical, and physical specifications, and by conducting standard performance and safety tests for EEG acquisition devices.

Table of Acceptance Criteria and Reported Device Performance (Technical Parameters):

Performance Characteristic	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Okti)
General	Substantial equivalence to predicate (Grael EEG)	All tests passed; results equivalent to Grael.
Usage: Intended Use	EEG studies to assist in diagnosis of neurological disorders.	EEG studies to assist in diagnosis of various neurological disorders.
Use Environment	Hospital / Clinical use only	Hospital / Clinical use only
Temperature	-10°C to 50°C storage/non-operating; 0°C to 40°C operating	-10°C to 50°C storage/non-operating; 0°C to 40°C operating
Relative Humidity	20 to 90% relative humidity non-condensing	20 to 90% relative humidity non-condensing
Altitude	< 3000m	< 3000m
Electrical Safety (IEC 60601-1:2005)	No detrimental effects on patients, others, or surroundings. Protection against electrical shock & other hazards.	Tests successfully completed, ensuring safety.
Electromagnetic Compatibility (IEC 60601-1-2)	Emissions within allowable limits; immunity against electrical/magnetic phenomena.	Tests successfully completed, ensuring conformity.
EEG Specific Performance (IEC 80601-2-26)	Accuracy of amplitude and rate of variation signal reproduction, input dynamic range, differential offset voltage, input noise, frequency response, common mode rejection ratio.	Validation against multiple essential performance requirements completed and passed.
Input Impedance	> 100 MΩ channels 1-32; > 20 MΩ channels 33-40 (Grael)	> 100 MΩ all channels
Bias Current	Typically 1nA	Typically 1nA
Input Noise	< 2 µV peak-to-peak typical (referential)	< 2 µV peak-to-peak typical (referential)
Input Range	User Selectable (300mV to 3000mV peak-to-peak)	User Selectable (300mV to 3000mV peak-to-peak)
CMRR (Common Mode Rejection Ratio)	> 100dB	> 100dB
Crosstalk	< -60dB	< -60dB
High Pass Filter	DC Coupled on all channels	DC Coupled all channels
Low Pass Filter	Specific 3dB cut-off frequencies at given sampling rates	Specific 3dB cut-off frequencies at given sampling rates (identical to predicate)
Notch Filter	Software based filtering of 50Hz, 60Hz or off	Software based display filtering of 50Hz, 60Hz or off
Isolation Specifications	Complies with IEC 60601-1	Complies with IEC 60601-1
Analogue to Digital Converter	24 bit resolution	24 bit resolution
Sample and Data rates	Data sampled at 16384 samples/sec; output rates 256-4096 samples/sec.	Data sampled at 16384 samples/sec; output rates 256-4096 samples/sec.
Power Consumption	< 10 Watts (Grael)	< 4 Watts

Study Details (Technical Validation, Not Diagnostic Performance):

As the document pertains to the technical aspects of an EEG acquisition device, not an AI-driven diagnostic tool, the following points are addressed based on what is available:

Sample size used for the test set and the data provenance:
- No "test set" in the context of diagnostic data (e.g., medical cases/images) is mentioned. The testing involves "extensive collection of tests" against electrical safety, EMC, and EEG specific performance standards.
- No information on data provenance (country of origin, retrospective/prospective) because it's not a dataset for diagnostic evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is adherence to engineering and safety standards (e.g., a specific noise level is verifiable by instrumentation, not expert consensus on a diagnosis).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication is not relevant for technical performance testing against fixed standards.
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. This is an EEG recording device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an EEG recording device. Its "performance" is about accurate signal acquisition and processing, not about an algorithm making a diagnosis. The device's analysis capabilities are implicitly linked to its software, but it's not presented as an AI making diagnostic predictions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on engineering specifications, regulatory standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26), and direct comparison to a predicate device's established performance. It's about the device's physical and electrical characteristics meeting predefined benchmarks for an EEG system, not clinical diagnostic accuracy based on patient outcomes or expert readings.
The sample size for the training set:
- Not applicable. This device is not an AI/ML diagnostic algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as no training set for an AI/ML algorithm is mentioned.

In summary: The provided document is for the regulatory clearance of a medical device (EEG hardware and associated software for acquisition) based on its technical specifications and substantial equivalence to a predicate, not for an AI/ML diagnostic algorithm whose performance would be assessed through clinical studies with expert-adjudicated ground truth.

Summary

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February 9, 2023

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Compumedics Limited % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K230073

Trade/Device Name: Okti Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: January 6, 2023 Received: January 10, 2023

Dear Dave Yungvirt:

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,

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)

Device Name Okti

Indications for Use (Describe)

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)

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510(k) Summary

Device Name: Okti

The following 510(k) summary is being submitted in accordance with 21 CFR 807.92.

Submission Details

Fax number:

Applicant Information:

Submitter:	Compumedics Limited
Address:	30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia
Phone number:	+61 (0) 3 8420 7300
Fax number:	+61 (0) 3 8420 7399
Contact person:	Michael Frischman
Address:	30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia
Phone number:	+61 (0) 3 8420 7362

Email: michael.frischman@compumedics.com.au Submission Prepared: 02/11/2022

Subject Device Information:

Trade name:	Okti
Common name:	Okti
Primary Product code:	GWQ
Classification Names:	Full-Montage Standard Electroencephalograph
Panel:	Neurology
Device class:	II
Regulation numbers:	21 CFR 882.1400

61 (0) 3 8420 7399

Predicate Device Information

Trade Name:	Grael System
Model:	Grael EEG
Manufacturer:	Compumedics Limited
510(k) number:	K093223
510(k) Decision Date:	15th January 2010
Classification:	Full-Montage Standard Electroencephalograph, Ventilatory Effort Recorder
Product code:	GWQ, MNR
Device class:	II
Regulation numbers:	21 CFR 882.1400

Intended Use / Indications For Use

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Device Description

Physically, the Okti comprises a base unit housing the battery and digital electronic circuits. A changeable module connects to the base unit and houses the analogue circuity and electrode connectors providing options for 32, 64 or 128 referential, or single ended, channels primarily intended for EEG. Each module includes several differential inputs for electrode-based signals such as ECG, EMG or EOG. All these inputs are class CF for patient safety.

Patient physiological data is digitised using multiple 24-bit ADCs and filtered using fixed point FIR filters implemented internally to an FPGA located in the analogue module. The data is transferred to a generalpurpose processor in the base unit over a synchronous serial link. From there the patient data may be saved to a device internal SD card or sent to a remote PC over an Ethernet or Wi-Fi LAN connection. A Bluetooth interface is also included for connection to external devices such as an oximeter.

The Okti system is available in Okti32, Okti64, or Okti128. These differ only in channel number with below characteristics.

Model	Inputs
Okti32	32, DC-coupled, fully isolated, referential (monopolar); 8 user-defined, DC-coupled, fully isolated, bipolar inputs
Okti64	64, DC-coupled, fully isolated, referential (monopolar); 4 user-defined, DC-coupled, fully isolated, bipolar inputs
Okti128	128, DC-coupled, fully isolated, referential (monopolar); 8 user-defined, DC-coupled, fully isolated, bipolar inputs

Comparison to Predicate Device

The Okti's predicate device is the Grael (K093223) comprises two primary models: the Grael, is a full channel device suitable for conducting either PSG or EEG studies; and the Grael EEG, a reduced channel device suitable for EEG studies only.

The Grael EEG is optimized for neurological studies, and does not contain inputs used for respiratory monitoring during PSG which are not necessary for neurological studies. The Grael EEG model is the predicate device and claims relating to PSG are not being made for the Okti.

Characteristic	Okti	Grael EEG
Usage
510(k) Number	-	K093223
Classification	882.1400	882.1400
Product Code	GWQ	GWQ
Class	II	II
Intended Use	EEG studies to assist in thediagnosis of variousneurological disorders	EEG studies to assist in thediagnosis of variousneurological disorders
Type of Use	Prescription Only	Prescription Only
Use Environment	Hospital / Clinical use only	Hospital / Clinical use only
Temperature	-10°C to 50°C storage/non-operating0°C to 40°C operating	-10°C to 50°C storage/non-operating0°C to 40°C operating
Relative Humidity	20 to 90% relative humiditynon-condensing	20 to 90% relative humiditynon-condensing
Altitude	< 3000m	< 3000m
	Physical Specifications
	Dimensions	Base unit: 84mm x 43mm x 184mmAmplifier module: 32ch 84mm x 26mm x 150mm64-ch: 84mm x 25mm x 150mm128-ch: 84mm x 33mm x 150mm
	Mass	Base unit: < 225g battery not fitted< 555g battery fittedAmplifier module weight:32ch < 145g64-ch < 170g128ch < 155g
	Electrical Specifications
	Power Supply	Power is provided by either rechargeable Lithium-ion battery (6400 mAH, > 300 charge/discharge cycle at 23°C, 11.25 volts) or Power Over Ethernet (either mid-span injector or PoE switch, per IEEE 802.3af standard)
Operating Voltage	48 Volts	48 Volts
Power Consumption	< 4 Watts	< 10 Watts
	Channel Specifications
Input Impedance	> 100 MΩ all channels	> 100 MΩ channels 1-32> 20 MΩ channels 33-40
Bias Current	Typically 1nA	Typically 1nA
Input Noise	< 2 µV peak-to-peak typical(referential)	< 2 µV peak-to-peak typical(referential)
Input Range	User Selectable:300mV peak-to-peak 600mV peak-to-peak 1200mV peak-to-peak 3000mV peak-to-peak	User selectable:300mV peak-to-peak600mV peak-to-peak1200mV peak-to-peak3000mV peak-to-peak
CMRR	> 100dB	> 100dB
Crosstalk	< -60dB	< -60dB
High Pass Filter	DC Coupled all channels	DC Coupled on all channels
Low Pass Filter	3dB cut-off frequency (fc) at sampling rate (Fs):fc = 71 Hz, Fs = 256 Hzfc = 143 Hz, Fs = 512 Hzfc = 284 Hz, Fs = 1024 Hzfc = 580 Hz, Fs = 2048 Hzfc = 1150 Hz, Fs = 4096 Hz	3dB cut-off frequency (fc) at sampling rate (Fs):fc = 71 Hz, Fs = 256 Hzfc = 143 Hz, Fs = 512 Hzfc = 284 Hz, Fs = 1024 Hzfc = 580 Hz, Fs = 2048 Hzfc = 1150 Hz, Fs = 4096 Hz
Notch Filter	Software based display filtering of 50Hz, 60Hz or off	Software based filtering of 50Hz, 60Hz or off
Isolation Specifications	Complies with IEC 60601-1	Complies with IEC 60601-1
Analogue to DigitalConverter	24 bit resolution	24 bit resolution
Sample and Data rates	Data sampled at 16384samples per second anddecimated to data ratesshown below. Actual datarate sent is determined bycontrolling PC softwareapplication.Output data rates of 4096,2048, 1025, 512 or 256samples per second.	Data sampled at 16384samples per second anddecimated to data ratesshown below. Actual datarate sent is determined bycontrolling PC softwareapplication.Output data rates: 4096,2048, 1024, 512, or 256samples per second.
Communication Interface
Software	Profusion EEG for amplifierconfiguration, dataacquisition, and display	Profusion EEG for amplifierconfiguration, dataacquisition, and display
Network Types	IEEE 802.3/802.3u Ethernet,auto MDIX Requires an IEEE802.3af compliant switch ormid-span power injector andnetwork isolatorWi-Fi interface IEEE 802.11a,802.11b, 802.11g and802.11n compatible	802.3/802.3u twisted pairEthernet with auto MDIX;RJ45 connector

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Summary of Performance Data

An extensive collection of tests have been conducted and successfully completed including,

. Electrical Safety Testing as per IEC 60601-1:2005. These ensure there is no potential for detrimental effects on patients, other persons, animals or the surroundings. They relate particularly to aspects concerning electrical safety such as means of operator protection, protection against electric shock and other hazards; as well as mechanical aspects such as construction and protection against spillage.
. Electromagnetic Compatibility Testing as per IEC 60601-1-2, and modification by the listed particular and collateral standards. These EMC tests were designed to verify that device emissions are in accordance with allowable limits, as well as device immunity against electrical and magnetic phenomena which may be expected to encounter in line with its intended use.
. Electroencephalograph safety and performance testing as per IEC 80601-2-26. Testing against the particular standard for electroencephalograph includes validation against multiple essential performance requirements such as accuracy of amplitude and rate of variation signal reproduction, input dynamic range and differential offset voltage, input noise, frequency response, and common mode rejection ratio.
Bench testing against Okti functional requirements to ensure that performance meets hardware and software design specifications

Further details such as device specifications, test requirements, acceptance criteria, results, and evaluation are available throughout this 510(k) submission. All tests passed with results equivalent to the Grael, and did not raise additional concerns of safety and effectiveness.

Conclusion

Compumedics Ltd. considers the Okti to be substantially equivalent to its predicate devices the Grael System, specifically the Grael EEG model. The indications for use, technological characteristics, and

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underlying principles of operation are the same. There are no questions of safety and effectiveness, and substantial equivalence is supported by extensive performance testing data.

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).