XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 by EXCEL TECH. LTD.

Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional . polygraphic recorders, signal transducers or amplifiers
Selection of recorded signal sections for on-screen review, annotation annotation of sleep stages .
Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals
Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and . frequency and simple statistical measures of marked events)

The PSG-40 is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.

The PSG-40 requires competent user input, and its oulput must be reviewed and interpreted by trained polysomnographers or neurologists who will exercise professional judgement in using this information.

The PSG-40 does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for the XLTEK PSG-40 Polysomnography Headbox. It primarily focuses on the device's substantial equivalence to predicate devices and provides its intended use. However, it does not contain the detailed information necessary to describe acceptance criteria and a study proving those criteria are met.

The document outlines the indications for use, stating the device is for sleep recordings (polysomnography) in research or clinical environments to:

Digitally record high-level output signals (EEG, respiratory, oximetry).
Allow selection of recorded signal sections for on-screen review and annotation of sleep stages.
Provide computer-assisted event marking and quantitative analysis of EEG, respiratory, and oximetry signals.
Generate computer-assisted reporting of simple measures from recorded signals.

It explicitly states that the PSG-40 is not intended to replace conventional devices in critical care or intraoperative settings, requires competent user input, and its output must be reviewed and interpreted by trained polysomnographers or neurologists, and does not make diagnostic judgments.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because the provided text does not contain this data.

Here's a breakdown of why this information is missing based on your request:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory approval based on substantial equivalence, not performance metrics.
Sample size used for the test set and the data provenance: Not present. No specific test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. "Ground truth" for device performance is not discussed.
Adjudication method: Not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not present. This type of study is not mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a hardware headbox, not an AI algorithm.
The type of ground truth used: Not present.
The sample size for the training set: Not present. This is not an AI/machine learning device that would typically have a "training set" in that context.
How the ground truth for the training set was established: Not present.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the top and left side of the circle.

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

Mr. Mark T. Zajac, P. Eng. Quality Engineer and Regulatory Affairs Excel Tech Ltd. 2892 Portland Drive Oakville, Ontario Canada L6H 5W8

APR - 9 2012

Re: K991900

Trade/Device Name: XLTEK PSG-40 Polysomnography Headbox Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV Dated (Date on orig SE ltr): June 3, 1999 Received (Date on orig SE Itr): June 4, 1999

Dear Mr. Zajac:

This letter corrects our substantially equivalent letter of July 12, 1999.

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. 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.

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Page 2 - Mr. Mark T. Zajac

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); 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.

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

Image /page/1/Picture/7 description: The image shows a signature on the left side and some text on the right side. The text includes the words "Director" and "Officer", suggesting that the signature may be from a director or officer of an organization. The signature is illegible, but it appears to be written in cursive.

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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EXCEL TECH, LTD. 510(K) NOTIFICATION OF A NEW DEVICE : "XLTEK PSG-40 POLYSOMNOGRAPHY HEADBOX"

ATTACHMENT # 1 STATEMENT OF INDICATIONS FOR USE

Page __ 1_ of ________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):	K991900
Device Name:	XLTEK PSG-40 Polysomnography Head box

Indications for Use :

...

The XLTek PSG-40 may be used for sleep recordings (polysomnography) in research or clinical environments for:

Digital recording of high-level output signals (such as EEG, respiratory and oximetry signals) from conventional . polygraphic recorders, signal transducers or amplifiers
Selection of recorded signal sections for on-screen review, annotation annotation of sleep stages .
Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximetry signals �
Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and . frequency and simple statistical measures of marked events)

The PSG-40 is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intraoperative settings.

The PSG-40 does not make any judgement of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion Sign-Off
on of General Restorative Devices
510(k) Number	K991900

Prescription Use	X	OR	Over-The Counter Use
(Per 21 CFR 801.109)

(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).