STELLATE GRIDVIEW by EXCEL-TECH LTD. (XLTEK)

The GridView software is indicated for use by qualified and trained medical personnel for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed.

Device Description

AI/ML Overview

I'm sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "Stellate Gridview" (later referred to as "GridView Software") and it primarily focuses on the substantial equivalence determination.

Specifically, the text doesn't include:

A table of acceptance criteria and reported device performance.
Details about sample sizes for test sets, data provenance, or training sets.
Information about the number or qualifications of experts, or how ground truth was established for either test or training sets.
Adjudication methods.
Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or details about standalone algorithm performance studies.
The type of ground truth used (e.g., pathology, outcomes data).

The document states the indications for use of the GridView software, which is "for the visualization and reporting of the electrical activity of the brain in adult patients with intracerebral electrodes. This reporting is obtained by user annotation of images of the patient's brain (MRI) on which images of the electrodes are superimposed." However, it does not provide study details demonstrating how well the device performs these functions against specific criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Excel-Tech, Ltd. c/o Ms. Goldy Singh Director of Quality and Regulatory 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

Re: K100126

Trade/Device Name: Stellate Gridview Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLX and LLZ Dated: October 29, 2010 Received: November 1, 2010

Dear Ms. Singh:

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.

DEC - 3 2010

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Page 2 - Ms. Goldy Singh

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,

Ruk. Atteun, m for
Melvin R. Felder, M.D.

Malvina B. Eydelman, M.I 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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INDICATIONS FOR USE STATEMENT

.. . .

DEC - 3 2010

K100126 ______________________________________________________________________________________________________________________________________________________________________ 510(k) Number:

Device Name: Gridview Software

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ V (Per 21 CFR 801.109)

OR.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

KRISTEN BOWSHER
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat 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).