The Geodesic EEG System™ 300 (GES 300) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

Device Description

The Geodesic EEG System™ 300 (GES 300) is a digital electroencephalograph system (EEG) with dedicated electrodes. It consists of an amplifier, computer, software . Geodesic Sensor Net® (electrodes), and additional components such as cables. Modifications which constitute the GES 300 include a compact amplifier, software upgrade, additional display modes and tools, and options for computer configuration.

AI/ML Overview

The provided text describes a 510(k) submission for the Geodesic EEG System™ 300 (GES 300). However, it explicitly states:

"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

This means that the submission does not include information about acceptance criteria, device performance, or a study that proves the device meets specific criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the submission focuses on demonstrating that the GES 300 modifications (compact amplifier, software upgrade, additional display modes and tools, and computer configuration options) do not alter the technological characteristics of the predicate device (Geodesic EEG System™ K012079) and that basic verification and validation testing has been conducted to ensure the device functions as intended.

Therefore, for all the requested information, the answer is that the details are not available or not applicable based on the provided text.

Here's a breakdown of why each specific point cannot be addressed:

A table of acceptance criteria and the reported device performance
- Not available: The document explicitly states "Comparative performance testing and clinical evaluations were not submitted." This implies no specific performance metrics or acceptance criteria for clinical efficacy were provided in this 510(k) submission. The "verification and validation testing" mentioned is likely related to engineering functionality and safety, not clinical performance.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available/Not applicable: Since no comparative performance or clinical evaluations were submitted, there is no "test set" in the context of clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available/Not applicable: No clinical test set means no ground truth established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available/Not applicable: No clinical test set means no adjudication method described.
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
- Not available/Not applicable: No comparative effectiveness study was done. Also, this device is an EEG system, not typically an "AI" device that assists human readers in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available/Not applicable: No standalone performance study was done. This device is an EEG recording system, not an algorithm performing interpretation independently.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not available/Not applicable: No clinical ground truth was used as no clinical performance study was submitted.
The sample size for the training set
- Not available/Not applicable: No clinical training set information is provided, as no clinical performance study was submitted.
How the ground truth for the training set was established
- Not available/Not applicable: No clinical training set information means no ground truth establishment method.

In summary, the 510(k) submission for the GES 300 focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and basic safety/functionality testing, rather than novel clinical performance studies.

Summary

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GES 300 System Special 510(k) Notification Page 28

K063797

510(k) SUMMARY

Submitter's name:	Electrical Geodesics, Inc.1600 Millrace Drive, Suite 307Eugene, OR 97403
Contact name and address:	Linda J. Bovard, Bovard Consulting LLC29611 Simmons Road, Eugene, OR 97405541-345-5431	JAN 26 2007
Date summary prepared:	December 19, 2006

Device name:

Proprietary name:	Geodesic EEG System™ 300 (GES 300)
Common or usual name:	EEG system
Classification name:	Electroencephalograph, 84 GWQClass II, 882.1400

Legally marketed device for substantial equivalence comparison: Geodesic EEG System™ submitted by Electrical Geodesics, Inc. K012079

Description of the device:

Intended use of device:

The Geodesic EEG System™ 300 is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

Technological characteristics:

The modifications which constitute the GES 300 do not alter the technological characteristics of the device. These modifications have been controlled by the EGI Design Control procedures.

Testing conducted:

Verification and validation testing has been conducted and the GES 300 passed all structured testing.

Performance testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with outstretched wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Electrical Geodesics Incorporated c/o Bovard Consulting LLC Ms. Linda J. Bovard, RAC 29611 Simmons Road Eugene, Oregon 97405

APR - 9 2012

Re: K063797

Trade/Device Name: Geodesic EEG System 300 (GES 300) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, GWQ Dated (Date on orig SE ltr): December 19, 2006 Received (Date on orig SE ltr): December 29, 2006

Dear Ms. Bovard:

This letter corrects our substantially equivalent letter of January 25, 2007.

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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GES 300 System Special 510(k) Notification Page 26

Indications for Use

510(k) Number (if known): _ K06 3 297

Deviee Name: Geodesic EEG System™ 300 (GES 300)

Indications for Use:

The Geodesic EEG System™ 300 (GES 300) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	11063797
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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).