The cortical surface electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical electrodes vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested. The Auragen Cortical Electrodes are available with platinum/iridium contacts, with 4 to 64 contacts. The electrodes are connected to Integra recording cables themselves connected to the hospital EEG recording equipment.

AI/ML Overview

The provided text describes a 510(k) submission for the Auragen™ Cortical Surface Electrodes, focusing on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish new performance metrics against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies for a new AI/medical device (like sample sizes, ground truth procedures, multi-reader studies, etc.) is not applicable to this document.

However, the document does mention some performance testing related to safety. I will extract what is available and indicate where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Safety Testing
MRI Compatibility	"MR Conditional" labeling claim as defined in ASTM F 2503-05 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment)	Device meets the "MR Conditional" labeling claim based on testing for radio frequency induced heating, magnetically induced displacement force, and torque.
MRI Artifacts	Localization of signal voids, considered "small in size in relation to the size and shape of the product."	Artifacts appeared as localized signal voids that were "small in size in relation to the size and shape of the product."
Sterility	Sterile	Provided sterile
Non-pyrogenic	Non-pyrogenic	Non-pyrogenic
Functional/Performance
Dimensional	Meet defined requirements of the product specification	Tested for dimensional performance and meets defined requirements.
Physical	Meet defined requirements of the product specification	Tested for physical performance and meets defined requirements.
Electrical	Meet defined requirements of the product specification	Tested for electrical performance and meets defined requirements.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document states "An array of cortical electrodes were subjected to MRI testing…" and implies individual electrodes were tested for dimensional, physical, and electrical performance. Specific numbers are not provided.
Data Provenance: Not applicable in the context of clinical data for AI/medical device performance. This testing appears to be primarily bench testing (e.g., MRI compatibility, physical/electrical tests) and manufacturing process checks (sterility, non-pyrogenic).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for bench testing (e.g., MRI compatibility, dimensional checks) would typically be established by standardized testing protocols and measurements, not expert consensus in the way clinical ground truth is established.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1) are typically used for establishing ground truth from expert readings of medical images or data. Bench testing relies on objective measurements against predefined specifications.

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

No. This is a 510(k) for a physical medical device (cortical electrodes), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a physical medical device. Standalone algorithm performance is not applicable.

7. The type of ground truth used

Bench Test Standards: For MRI compatibility, the ground truth was established by adherence to ASTM F 2503-05, a standard practice for marking medical devices for safety in the MR environment.
Product Specifications: For dimensional, physical, and electrical performance, the ground truth was "defined requirements of the product specification."

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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KOT2STO

OCT 1 0 2008

Auragen™ Cortical Surface Electrodes 510(k) SUMMARY

Submitter's name and address:

Integra NeuroSciences Implants SA 2905 Route des Dolines 06921 Sophia Antipolis Cedex, France

Contact person and telephone number:

Anne Bigeard, Regulatory Affairs Manager Telephone: +33 (0)4 93 95 5667 Facsimile: +33 (0)4 93 65 4030

Date summary was prepared:

September 22, 2008

Name of the device:

Proprietary Name:	Cortical Surface Epilepsy Electrode
Common Name:	Cortical Electrodes
Classification Name:	Cortical Electrodes, GYC

Substantial Equivalence:

The modified cortical surface electrodes are substantially equivalent to the cortical surface electrodes cleared by the FDA under 510(k) (K926424). The design, intended use, materials of composition, functional/performance specifications, manufacturing process are equivalent to the previously cleared cortical surface electrodes.

Intended use:

The cortical surface electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.

Device Description:

Safety and Effectiveness:

An array of cortical electrodes were subjected to MRI testing, which included radio frequency induced heating, magnetically induced displacement force and torque. MR imaging artifacts were assessed and the artifacts that appeared were shown as localized signal voids that were considered small in size in relation to the size and shape of the product. Results of the testing supports a "MR

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Conditional" labeling claim as defined in ASTM F 2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. The cortical electrodes are provided sterile and are non-pyrogenic. The cortical electrodes have been tested for dimensional, physical and electrical performance and meet the defined requirements of the products specification.

Conclusion :

The modified cortical electrodes defined in this submission are substantially equivalent to the unmodified cortical electrodes cleared by the FDA under 510(k) (K926424). The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is rendered in black and white, giving it a formal and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integra Neurosciences % Integra Lifesciences Corporation Mr. Jon Caparotta Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

OCT 1 0 2008

Re: K082250

Trade/Device Name: Auragen Cortical Surface Electrodes Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: September 22, 2008 Received: September 23, 2008

Dear Mr. Caparotta:

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 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

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Page 2 - Mr. Jon Caparotta

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Mark N Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Auragen™ Strip and Grid Electrodes

Indications For Use:

The Auragen™ Cortical Surface Electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.

AND/OR Over-The-Counter Use Prescription Use x (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ই

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

510(k) Number 1<0 82250

Regulation Number and Section

§ 882.1310 Cortical electrode.

(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).