DuraGen Plus™ Dural Graft Matrix, is an absorbable implant for repair of dural defects. DuraGen Plus™ is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

AI/ML Overview

The provided text, a 510(k) summary for DuraGen Plus™ Dural Graft Matrix, does not contain the detailed information required to fill out the requested table and answer all questions regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study.

This document describes a medical device, DuraGen Plus™ Dural Graft Matrix, and seeks substantial equivalence to a predicate device. The assessment of this type of device typically involves physical property testing and not clinical trials or AI/human reader studies as would be the case for diagnostic or image-based AI software.

Here's how I can answer based only on the provided text, highlighting what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative or qualitative manner that would be filled in a table, nor does it provide specific performance metrics from a study related to those criteria. It broadly states the device is "safe and effective under the proposed conditions of use."

Acceptance Criteria	Reported Device Performance
Not specified in document	"Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen Plus™ Dural Graft Matrix is safe and effective under the proposed conditions of use..."

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

Not applicable. The clearance is based on physical property testing, not a test set of data from patients or images.

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

Not applicable. Ground truth for a test set is not relevant for this type of device clearance.

4. Adjudication method for the test set

Not applicable.

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 medical device (dural graft matrix), not an AI software/diagnostic tool.

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

No. This is a medical device, not an algorithm.

7. The type of ground truth used

Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for a dural graft matrix would relate to its physical and biological properties. The document mentions "physical property testing."

8. The sample size for the training set

Not applicable. There is no "training set" for this type of device.

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

Not applicable.

Summary of what the document does communicate about the study:

Study Type: The clearance is based on "Valid scientific evidence through physical property testing." This implies laboratory or bench-top testing of the material properties of the DuraGen Plus™ Dural Graft Matrix.
Conclusion of Study: The testing provided "reasonable assurance that DuraGen Plus™ Dural Graft Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device [DuraGen® Dural Graft Matrix (K982180)]."

Summary

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510(k) Summary DuraGen Plus™ Dural Graft Matrix Integra LifeSciences Corporation

KO32693

Confidential

DuraGen Plus™ Dural Graft Matrix 510(K) SUMMARY

Submitter's name and address:

Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA

Contact person and telephone number:

Diana M. Bordon Manager, Regulatory Affairs, (609) 936-2240

August 29,2003 Date:

Name of the device:

Proprietary Name:	DuraGen Plus™
Common Name:	Dural Graft Matrix
Classification Name:	Dura Substitute, Product Code 84GXQ
	Class II
	Regulation Number 882.5910

Substantial Equivalence:

DuraGen Plus™ Dural Graft Matrix is substantially equivalent in function and intended use to the currently marketed DuraGen® Dural Graft Matrix (K982180).

Intended Use:

DuraGen Plus™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

Device Description:

Conclusion:

Valid scientific evidence through physical property testing provide reasonable assurance that DuraGen Plus™ Dural Graft Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 2003

Ms. Diana M. Bordon Manager, Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K032693 Trade/Device Name: DuraGen Plus™ Regulation Number: 21 CFR 882.5910 Regulation Name: Dura substitute Regulatory Class: II Product Code: GXQ Dated: August 29, 2003 Received: September 3, 2003

Dear Ms. Bordon:

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 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. Diana M. Bordon

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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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K032693

INDICATIONS FOR USE

510(k) Number:

Device Name: DuraGen Plus™ Dural Graft Matrix

Indications for Use:

DuraGen Plus™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

Meriam C. Provost

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

510(k) Number K032693

(PLEASE DO NOT WRITE BEI.OW 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 _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).