This document is a 510(k) premarket notification for a medical device called the "80 Channel EEG". It seeks to demonstrate substantial equivalence to a predicate device, the "24 Channel Ambulatory EEG [FDA 510(k) K982479]". The document is a regulatory submission and does not contain detailed study information or acceptance criteria for device performance in the way typically seen for AI/ML devices.

Therefore, for aspects related to acceptance criteria, device performance, study design, and ground truth establishment, the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

Table of acceptance criteria and the reported device performance:
- Not applicable / Not provided. This document is a regulatory submission for substantial equivalence, not a performance study report with specific acceptance criteria (e.g., sensitivity, specificity, accuracy) for a new clinical claim or an AI algorithm. Its focus is on establishing that the new device (80 Channel EEG) is as safe and effective as a previously cleared device (24 Channel Ambulatory EEG) for the same intended use.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This document does not describe a clinical performance study with a test set. It's a submission for a device modification (increasing the number of channels for an EEG machine).
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 applicable / Not provided. There is no mention of an expert-adjudicated test set in this regulatory submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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 applicable / Not provided. This device is an electroencephalograph, not an AI-powered diagnostic tool. The submission is for a device modification (more channels), not a comparative effectiveness study involving human readers and AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This is an EEG hardware device, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
The sample size for the training set:
- Not applicable / Not provided. This document does not pertain to the development or validation of a machine learning algorithm.
How the ground truth for the training set was established:
- Not applicable / Not provided.

Summary of available information:

Device Name: 80 Channel EEG
Predicate Device: 24 Channel Ambulatory EEG [FDA 510(k) K982479]
Indications for Use: The 80 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.
Nature of Submission: Special 510(k) Device Modification, suggesting a change to an existing cleared device (likely the 24 Channel EEG was the basis, and this is an upgrade to 80 channels).
Regulatory Decision: The FDA determined the device is substantially equivalent to predicate devices.

Summary

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Image /page/0/Picture/0 description: This image shows a document with the XLTEK logo and the text "SPECIAL 510(K) DEVICE MODIFICATION". The document also includes the text "SPECIAL 510(K) 80 CHANNEL EEG", "DECEMBER 14, 2001", and "PAGE 49 of 51". There is also a handwritten number at the top right that reads "K014147".

Section F -- 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR § 807.92.

Name:	Cameron MahonVice President, Customer Satisfaction	JAN 1 4 2002
Address:	XLTEK2568 Bristol CircleOakville, OntarioCanada, L6H 5S1
Telephone:	(905) 829-5300
Fax:	(905) 829-5304
E-mail:	research@xltek.com
Common Names:	80 Channel EEG
Classification Name:	Electroencephalograph
Predicate Devices:	24 Channel Ambulatory EEG [FDA 510(k) K982479]
Description:	The 80 Channel EEG is a digital electroencephalograph
Substantial Equivalence:	The 80 Channel EEG is substantially equivalent to the 24 ChannelAmbulatory EEG [FDA 510(k) K982479]
Indications for Use:	The 80 Channel EEG is intended to be used as anelectroencephalograph: to acquire, display, store, and archiveelectroencephalographic signals.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2002

XLTEK Sonja Markez Regulatory Affairs 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Re: K014147

Trade Name: 80 Channel EEG Regulation Number: 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: December 14, 2001 Received: December 18, 2001

Dear Ms. Markez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Sonja Markez

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iction with and w you to ough anding of substantial equivalence of your device to a legally premation hoticated on " in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you dostro specific and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF 1 F ar 4659. Additionally, for questions on the promotion and advertising of Compination at (301) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oince general miorination on Joseph international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for XILTEK, followed by the words SPECIAL 510(K). Below the logo, the words SPECIAL 510(K) DEVICE MODIFICATION are printed. The image also contains the words 80 CHANNEL EE and DECEMBER 14, 20.

80 CHANNEL EEG DECEMBER 14, 2001 PAGE 50 of 51

Section G – INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

80 Channel EEG

Indications for Use:

The 80 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21§ CFR 801.109)

Over-The Counter Use

Mark n millenor

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number .

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).