The provided document is a 510(k) premarket notification for an XLTEK 84 Channel EEG device. It establishes substantial equivalence to a predicate device (24 Channel Ambulatory EEG [FDA 510(k) K982479]) rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these documents.

The 510(k) summary (pages 0 and 3) explicitly states that the device is "substantially equivalent" to the predicate device. This means the FDA has determined that the new device is as safe and effective as a legally marketed predicate device, and it does not typically involve the rigorous performance testing and clinical studies that would require the detailed information you've requested (such as sample sizes, ground truth establishment, MRMC studies, or standalone algorithm performance).

Here's what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the new device. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to the predicate device.
Reported Device Performance: None are explicitly reported in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) within these documents. The performance is implicitly assumed to be equivalent to the predicate device.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to predicate device (24 Channel Ambulatory EEG [FDA 510(k) K982479])	Met, as indicated by the FDA's clearance (K014146)
Acquire, display, store, and archive electroencephalographic signals	Implied to meet these functional requirements, consistent with the predicate device. Specific performance metrics (e.g., signal-to-noise ratio, bandwidth) are not provided in this summary.
(Further specific performance criteria related to EEG signal quality, artifact rejection, etc. are not detailed in this documentation.)	(Not reported in the provided text.)

Missing Information & Rationale:

The following requested points are not applicable or cannot be answered from the provided 510(k) summary documents, as they pertain to performance studies that are not typically required or detailed in a 510(k) for substantial equivalence based on functional equivalence to a predicate device.

2. 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: There is no mention of a test set or data provenance for a performance study.
3. 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: No ground truth establishment activity is described for the new device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided: No test set adjudication is mentioned.
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
- Not applicable: This device is an EEG acquisition and display system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable: This is a hardware/software system for acquiring EEG signals, not an algorithm being evaluated in a standalone mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided: No ground truth is established for device performance in this document.
8. The sample size for the training set
- Not applicable / Not provided: No training set is mentioned as this is not an AI/ML device that learns from data.
9. How the ground truth for the training set was established
- Not applicable / Not provided: No training set or ground truth establishment for it is mentioned.

In summary: The provided documents are a 510(k) summary and FDA clearance letter for an EEG device, focused on establishing substantial equivalence to an existing predicate device manufactured by the same company. This process generally does not involve new clinical performance studies with acceptance criteria, test sets, or ground truth establishment in the way you've described for, for example, a new diagnostic algorithm. The "study" here is the regulatory assessment of its technical characteristics and indications for use against a known predicate.

Summary

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Image /page/0/Picture/0 description: This image shows a document header with the XLTEK logo on the left. To the right of the logo is the text "SPECIAL 510(K) 84 CHANNEL EEG". Below the logo, it says "SPECIAL 510(K) DEVICE MODIFICATION", and to the right, it says "DECEMBER 14, 2001 PAGE 49 of 51". At the top of the image, the number "1014146" is written in handwriting.

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:	84 Channel EEG
Classification Name:	Electroencephalograph
Predicate Devices:	24 Channel Ambulatory EEG [FDA 510(k) K982479]
Description:	The 84 Channel EEG is a digital electroencephalograph
Substantial Equivalence:	The 84 Channel EEG is substantially equivalent to the 24 ChannelAmbulatory EEG [FDA 510(k) K982479]
Indications for Use:	The 84 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 three birds in flight, representing health, hope, and well-being. The seal is black and white.

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: K014146

Trade Name: 84 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) remarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of 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 Division of Small Manufacturers, 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 N Millerson

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 "XLTEK" along with the text "SPECIAL 510(k)" and "84 CHANNEL EEG". Below the logo, the text "SPECIAL 510(k) DEVICE MODIFICATION" is present. On the right side of the image, the date "DECEMBER 14, 2001" and the page number "PAGE 50 of 51" are displayed.

Section G -- INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

84 Channel EEG

Indications for Use:

The 84 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 OR

Mark N. Millerson

neral, Restorative and Neuros cal Devices Kol4146

510(k) Number -

(Optional Format 1-2-96)

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).