GORE DRAPEABLE ST and LT Regenerative Membranes are bioabsorbable, implantable materials intended to aid in the healing of periodontal and bone defects. They may also be used as a membrane for bone graft containment. When used over a bone graft, GORE DRAPEABLE ST and LT Regenerative Membranes provide a stable barrier to prevent migration of bone graft material and provides a favorable environment for bone regeneration. When used in the treatment of non-spacemaking defects, GORE DRAPEABLE ST and LT Regenerative Membranes should be used in combination with spacemaking bone graft materials (e.g., autogenous bone, bone substitutes).

Device Description

GORE DRAPEABLE ST and LT Regenerative Membranes are composed of a porous structure of synthetic resorbable glycolide and trimethylene carbonate copolymer fiber. The fiber web is designed to allow attachment to surrounding tissues, stabilize the wound and blood clot, inhibit epithelial downgrowth, and isolate the healing defect during the initial phases of wound healing. GORE DRAPEABLE ST and LT Regenerative Membranes have been designed to act in accordance with the accepted principles of wound healing and regenerative therapy. Specifically, the membranes are designed to be biocompatible, separate tissue (cell occlusive), clinically manageable, and allow for tissue integration. The fifth requirement for regenerative therapy is spacemaking, and bone grafting or bone filling materials may be used in conjunction with the membranes to assist in providing the space necessary for regenerative healing. GORE DRAPEABLE ST and LT Regenerative Membranes are surgically placed beneath the mucoperiosteum to aid in the regenerative healing of bone and periodontal ligament defects of the oral cavity or, when placed over bone graft material, to prevent graft material migration.

AI/ML Overview

The provided document does not describe a study that uses acceptance criteria and reports device performance in the way typically seen for AI/ML devices or diagnostic tools. Instead, it is a 510(k) summary for a medical device called "GORE DRAPEABLE ST and LT Regenerative Membranes," which is a bioabsorbable barrier membrane for oral surgical applications.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific performance against acceptance criteria in a quantitative manner. The assessment is based on preclinical studies and the device's functional characteristics.

Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

However, I can provide information based on what is available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Functional Integrity (Time to Absorption)	Consistent with the clinical goals of regenerative therapy.
Tissue Tolerance	Suitable for regeneration of bone.
Protection of Regenerative Environment	Provided protection of the regenerative environment.
Biocompatibility	Designed to be biocompatible.
Separate tissue (cell occlusive)	Designed to separate tissue (cell occlusive).
Clinically Manageable	Designed to be clinically manageable.
Allow for Tissue Integration	Designed to allow for tissue integration.
Similarity to Predicate Devices (GORE RESOLUT XT and GORE OSSEOQUEST Regenerative Membranes)	Device has an indication statement similar to, and intended use is the same as, predicate devices. The modified wording is consistent with other legally marketed resorbable regenerative membranes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: The document mentions "Preclinical studies conducted in critical size defects of the rat mandible." It does not specify the exact animal sample size.
Data Provenance: Preclinical studies, likely conducted by the manufacturer. No country of origin is explicitly stated, but the submission is to the US FDA. The studies would be considered prospective for the animals involved.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not mentioned. The assessment is primarily based on preclinical animal study observations and material characteristics, not human expert interpretation of data like images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not mentioned. This typically applies to human interpretation of data, which is not the primary assessment method described here.

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:

Not applicable. This is not an AI/ML device related to human interpretation of data.

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

Not applicable. This device is a physical, implantable membrane, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the preclinical studies would be based on histological and morphological assessment of tissue regeneration and integration within the animal models, along with observations of the membrane's degradation and functional properties.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/ML device for this physical product.

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

Not applicable.

Summary

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2 013346

DEC 1 9 2001

TAB J

510(K) Summary of Safety and Effectiveness

1. Applicant Name, Address:	W.L. Gore & Associates, Inc. 3450 W. Kiltie Lane P.O. Box 900 Flagstaff, AZ 86002-0900
Contact Person:	Jacqueline Kalbach (928)864-3731
Date of Summary:	October 5, 2001
2. Classification Name:	Resorbable Barrier Membrane
Common or Usual Name:	Regenerative Material
Proprietary Name:	To be determined

3. Device Description:

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Intended Use: 4.

GORE DRAPEABLE ST and LT Regenerative Membranes are bioabsorbable, implantable materials intended to aid in the healing of periodontal and bone defects. They may also be used as a membrane for bone graft containment. When used over a bone graft, GORE DRAPEABLE ST and LT Regenerative Membranes provide a stable barrier to prevent migration of bone graft material and provides a favorable environment for bone regeneration. gran material the treatment of non-spacemaking defects, GORE DRAPEABLE ST and LT Regenerative Membranes should be used in combination with spacemaking bone graft materials (e.g., autogenous bone, bone substitutes).

Technological Characteristics: 5.

GORE DRAPEABLE ST and LT Regenerative Membranes have been designed to act in accordance with the accepted principles of wound healing and regenerative therapy. Specifically, the membranes are designed to be biocompatible, separate tissue (cell occlusive), clinically manageable, and allow for tissue integration. The fifth requirement for regenerative therapy is spacemaking, and bone grafting or bone filling materials may be used to provide the space necessary for regeneration.

Assessment of Performance Data: 6.

Preclinical studies conducted in critical size defects of the rat mandible indicate that GORE DRAPEABLE ST and LT Regenerative Membranes provide protection of the regenerative environment and tissue tolerance suitable for regeneration of bone. The functional integrity and time to absorption of this material are consistent with the clinical goals of regenerative therapy.

7. Conclusion:

The modified GORE DRAPEABLE ST and LT Regenerative Membranes have an indication statement that is similar to the current GORE RESOLUT XT and GORE OSSEOQUEST Regenerative Membranes. Their intended use is the same: the modified GORE DRAPEABLE ST and LT Regenerative Membranes act as a barrier intended to allow controlled tissue regeneration and thus allow repair of periodontal and bone defects in the oral cavity. They may also be used as membranes for bone graft containment, and bone grafting or bone filling materials may be used in conjunction with the membranes to assist in providing the space necessary for regenerative healing. Thus, the modified GORE DRAPEABLE ST and LT Regenerative Membranes are substantially equivalent to the current GORE RESOLUT XT and GORE OSSEOQUEST Regenerative Membranes. The indication statement has been modified, and the added

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wording is consistent with that of other legally marketed resorbable regenerative membranes that also recommend the use of bone filling materials when nonspacemaking defects are treated.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2001

Ms. Jacqueline Kalbach Regulatory Affairs Associate W. L. Gore & Associates Medical Products Division 3450 Kiltie Lane P.O. Box 500 Flaggstaff, Arizona 86002-0500

Re: K013346

Trade/Device Name: Gore Drapeable St/Lt Regenerative Membrane Regulation Number: None Regulation Name: Regenerative Material Regulatory Class: Unclassified Product Code: LYC Dated: October 5, 2001 Received: October 9, 2001

Dear Ms. Kalbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottewou your betermined the device is substantially equivalent (for the relerenced above and have acteriminoure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Include comments, or to devices that have been reclassified in accordance with the provisions of Amondinente, or to arrestic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or an al 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 (1 Mrt), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Kalbach

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Pat 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy . Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known) ____________________________________________________________________________________________________________________________________________________

Device Name: GORE DRAPEABLE ST and LT Regenerative Membranes

INDICATIONS FOR USE:

GORE DRAPEABLE ST and LT Regenerative Membranes are bioabsorbable, GURE DRAF EADLE OF and ET Regoneraling of periodontal and bone
implantable materials intended to aid in the healing of periodontal and bone implantable materials intended to and membrane for bone graft containment.
defects. They may also be used as a membrane of a contralian delects. They may also be assult as a moments of and LT Regenerative When used over a bone grant, OORLE over in migration of bone graft material Membranes provide a stable barner to proveneration. When used in the and provides a favorable environment . GORE DRAPEABLE ST and LT
treatment of non-spacemaking defects, GORE DRAPEABLE SC and LT treathent of non-spacemaking donoter of one ination with spacemaking bone Regencrative Monibrancemous bone, bone substitutes).

(Please do not write below 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)

Susan Ryan

IDivision Sign-Off) Prision of Dental, Infection Control, are General Hospital Devices
Number __________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.