The GRAEL 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 sleep disorders or neurological disorders. The Grael is designed for use in a hospital or other clinical environment. The Grael is only to be used under the direction of a physician.

Device Description

Grael and Grael EEG are standalone units, which together with sensors and a PC running Compumedics PSG Online and Profusion PSG software for sleep studies and/or Profusion EEG for EEG studies, can record, review and analyze a number of physiological parameters, including EEG, EOG, EOG and respiratory signals. These are then used as an aid in the diagnosis of respiratory and/or neurological related sleep disorders or other neurological conditions by qualified physicians. The system is comprised of hardware and software which, depending on the model type, provides up to 60 separate parameters for recording, review and analysis.

AI/ML Overview

The provided text (K093222 submission for the GRAEL SYSTEM) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information typically found in a clinical study report that would describe acceptance criteria and the methods used to prove the device meets them in the way modern AI/medical device submissions do.

Specifically, the document:

Identifies predicate devices and states that the GRAEL SYSTEM is substantially equivalent to them.
Describes the system's hardware and software components and their functions.
Lists shared technologies with other approved devices, implying that their prior approval supports the safety and effectiveness of these components in the GRAEL SYSTEM.
States the intended use of the device.

However, it does not include:

A table of acceptance criteria and reported device performance metrics in the format requested.
Details about a specific study designed to prove the device meets performance criteria, especially in the context of an AI/ML algorithm's analytical or clinical performance.
Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or any form of comparative effectiveness study (MRMC or standalone algorithm performance).

Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving their fulfillment based on the provided text.

This K093222 submission is from 2010. The regulatory framework and expectations for demonstrating device performance, particularly for AI/ML-driven devices, have evolved significantly since then. For devices like the GRAEL SYSTEM, the "acceptance criteria" at the time would primarily revolve around demonstrating that the device functions as intended, is safe, and is substantially equivalent to existing predicate devices, likely through electrical safety testing, EMC testing, and functional verification. The "study" would often refer to the documentation of these engineering tests and a comparison table establishing substantial equivalence.

Without additional documentation (e.g., a specific verification and validation report or clinical study report), the requested information cannot be extracted from this 510(k) summary.

Summary

{0}------------------------------------------------

K093222

. Hela 1 & Co.,

5.510(k) Summary

In accordance with 21 CFR 807.92, the following information constitutes the Compumedics Limited summary for the GRAEL SYSTEM.

JAN 1 5 2010

SUBMITTER'S NAME:	Compumedics Limited
ADDRESS:	30-40 Flockhart Street,Abbotsford, Victoria, 3067Australia
CONTACT PERSON:	Gordon Ferguson
TELEPHONE NUMBER:	+61 3 8420 7300
FAX NUMBER:	+61 3 8420 7399
DATE OF SUBMISSION:	6 October 2009

Identification of device

Proprietary Name:	Compumedics Grael System
Common Name:	GRAEL SYSTEM
Classification Status:	Class II per regulations 882.1400, 868.2375
Product Codes:	GWQ, MNR

Predicate devices

Compumedics Limited believes the GRAEL SYSTEM is substantially equivalent to:
Device name:	Compumedics Siesta System
Supplier:	Compumedics Limited
510(k) number:	K003175

Other predicate devices have been used for comparison where features or technology in the Grael are not present in the Compumedics Siesta System. Other predicate devices compared are:

で Compumedics Summit IP, 510(k) number K040194
. Compumedics Somté PSG, 510(k) number K072201
Compumedics E-Series System, 510(k) No .: K000068
0 Compumedics P-Series System, 510(k) No .: K955841
Neuroscan Labs Scan LT40, 510(k) No .: K001564 .
. Compumedics Neuvo System, 510(k) No .: K081151

{1}------------------------------------------------

Description of the System

ಿ

Two different Grael models are available:

. Grael, is a full channel device suitable for conducting either - PSG (polysomnographic - sleep), or EEG (electroencephalographic neurological) studies;
Grael EEG, is a reduced channel device suitable for EEG studies only. o

NOTE - Unless otherwise noted the information in this submission applies to both devices and the name Grael is used to refer to either device type. Where necessary the name Grael EEG is used to explicitly indicate functionality that is either not present in or unique to the Grael EEG.

NOTE - "Grail" is the project name that was assigned to the Grael hardware development project.

Power is supplied to the Grael via the network cable using either a Power over Ethernet (PoE) switch or power injector.

Intended use

Shared Technologies

The Grael System incorporates technology shared with other approved devices:

Pulse Oximetry Vampire module as used in Somté PSG (K072201) ●
. Inductive plethysmography - Technology as used in Summit IP (K040194)
High frequency channels (EEG, EMG, and EOG) are identical to the . technology used in the Siesta system (K003175), with the exception that these are sampled at a higher rate than the Siesta.
Recording of the ECG channel is identical to the Somté PSG (K072201) .
Pressure monitoring is identical to the Somté PSG (K072201) .

{2}------------------------------------------------

Airflow monitoring via thermal oro-nasal sensor is identical to the Somté . PSG (K072201)
Automatic analysis via the Profusion PSG software is identical to the . Somté PSG System (K072201)
. Profusion EEG (4.0) software is identical to that in the Neuvo System (K081151)
Photic Stimulator Identical to that included with the Scan LT40 (K001564) .

Compumedics Grael System 510(k) Submission

-T

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are written vertically along the left side of the symbol. The symbol is black and white.

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

JAN 1 5 2010

Stuart King Product Manager Compumedics Limited 30-40 Flockhart Street Abbotsford Vic 3067 Australia

Re: K093223

Trade/Device Name: Compumedics GRAEL SYSTEM (Models: Grael and Grael EEG), Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ, OLV, and OLZ Dated: December 10, 2009 Received: December 11, 2009

Dear Mr. King:

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.

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 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.

{4}------------------------------------------------

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/ucm1.15809.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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Kesia Alexander for

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

{5}------------------------------------------------

Indications for Use Statement

510(k) Number K095223

Device Name: GRAEL SYSTEM

Indications for Use:

The GRAEL 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 sleep disorders or neurological disorders. The Grael is designed for use in a hospital or other clinical environment. The Grael is only to be used under the direction of a physician.
Prescription Use OR (Per Part 21 CFR 801 Subpart D)

Over the Counter Use

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kristen Bowsher

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_KQ93223

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).