BioMesh® Biodegradable GTR Barrier is intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures.

Indications for Use:
BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions:

Two or three wall vertical defects.
Class II furcations.
Circumferrential defects.
Recession type defects.
Dehisence defects associated with dental implants

Device Description

BioMesh® Biodegradable GTR Barrier is provided as a single membrane type, but in a variety of precut shapes and sizes. Shapes and sizes. As noted on the graphic representation at the left, five different shapes are offered. The BioMesh® Biodegradable GTR Barrier is shape optimized to provide a ready made pattern well suited to the selected operative site needing a minimum of surgeon modification. If desired, the surgeon can trim any of the available shapes to fit unique or unusual circumstances. The BioMesh® Biodegradable GTR Barrier is made from polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer. The membrane is constructed with interconnective pores with an embossed surface.

AI/ML Overview

This is a 510(k) premarket notification for a dental device, not an AI/ML device, therefore, much of the requested information (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or available in the provided document. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on performance against specific acceptance criteria in the context of AI.

I can, however, extract the acceptance criteria as presented in the "Summary Comparison Table" and the reported performance of the device against those criteria in the context of substantial equivalence.

1. Table of acceptance criteria and the reported device performance:

Feature	Acceptance Criteria (Predicate Device - Resolut)	Reported BioMesh® Biodegradable GTR Barrier Performance	Substantial Equivalence (SE?)
Indications for Use:	Two or three wall vertical defects, Class II furcations, Circumferential defects, Recession type defects, Dehisence defects associated with dental implants	SAME	YES
Material:	Equivalent (to polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer)	polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer	YES
Structure:	Non-woven membrane, no interconnecting pores, no embossing	Microporous membrane made of biodegradable polyglycolide, polylactide and d,l-lactide/glycolide copolymer. The membrane is made up of interconnective pores with an embossed surface.	Equivalent
Tissue Integration:	Test result score 110	Test result score 115	YES
Biocompatibility:	Good	Good	YES
Toxicity:	Good	Good	YES
Stability:	5 Years	5 Years	YES
Clinical Data:	Good	Good	YES
K - Number:	K932866, K962624 & K973594	Pending	YES

Study that Proves the Device Meets the Acceptance Criteria:

The provided document describes a substantial equivalence comparison to predicate devices (Resolut Regenerative Material, K932866, K962624, and K973594) rather than a direct study with predefined acceptance criteria for a novel AI/ML device. The "study" here is essentially the comparison itself, as presented in the "Summary Comparison Table." The criteria are largely based on the characteristics and performance of the legally marketed predicate device.

The document states: "Comparison of BioMesh® Biodegradable GTR Barrier brand GTR barrier to the predicate device(s) identified above based on available labeling, promotional materials, comparison testing, demonstrates the substantial equivalence of Biodegradable GTR Barrier."

According to the table:

Indications for Use, Material, Biocompatibility, Toxicity, Stability, Clinical Data, Manufacturer, and Product Code were deemed "SAME" or "Good" or identical to the predicate.
For Structure, while the description differs (microporous with interconnective pores and embossing vs. non-woven without these features), the conclusion is "Equivalent," implying that these structural differences do not alter the safety or effectiveness to a degree that would preclude substantial equivalence. This likely relies on performance data where applicable, though extensive structural details are not provided.
For Tissue Integration, BioMesh® showed a test result score of 115, which is numerically higher than the predicate's 110, leading to a "YES" for substantial equivalence. This suggests that a higher score is either equivalent or superior in this context.

Missing Information/Not Applicable for this specific document (as it's not an AI/ML device submission):

Sample size used for the test set and the data provenance: Not explicitly stated for specific elements like tissue integration. The comparison is against predicate device characteristics and likely pre-existing data or tests, not a new clinical trial with a defined test set for this submission. The origin of "test result scores" for tissue integration is not detailed (e.g., in vivo animal study, in vitro, human data).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device is not relevant here.
Adjudication method: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For characteristics like material, stability, etc., the "ground truth" is established through standard material science and performance testing. For "clinical data," it likely refers to general acceptable clinical performance of such devices, but no specific ground truth definition is provided.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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4/9/99

K990363

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

Trade Name: 1.
BioMesh® Biodegradable GTR Barrier

Common Name(s): GTR Barrier

Classification Name(s): Unclassified device

1. Establishment Name & Registration Number: Name: SAMYANG CORPORATION Number: Pendina
1. Classification:

Device Class: ll Classification Panel: Dental Product Code(s): LYC

4. Equivalent Predicate Device:

SAMYANG CORPORATION believes that BioMesh® Biodegradable GTR Barrier is substantially equivalent to Resolut Regenerative Material as characterized in K932866, K962624 and K973594.

1. Gore Resolut Regenerative Material, K932866, K962624 & K973594
  Comparison of BioMesh® Biodegradable GTR Barrier brand GTR barrier to the predicate device(s) identified above based on available labeling, promotional materials, comparison testing, demonstrates the substantial equivalence of Biodegradable GTR Barrier.

5. General Device Description:

6. Applicant Name & Address:

SAMYANG CORPORATION

263 Yeonji-dong, Chongno-gu Seoul 110-725, Korea

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7. Company Contact:

Mr. Dong-Kee Yoo SAMYANG CORPORATION 263 Yeonji-dong, Chongno-gu Seoul 110-725. Korea Tel. 011.82.2.740.7296 Fax 011.82.2.743.6626

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

Performance Standards: ರು

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include U.S.P., ASTM, Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

Storage, Packaging & Sterilization Information: 10.

Packaging. Packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. If the package or product is damaged, the product should not be used and should be returned. Once opened, the product should never be resterilized or reused. Storage. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. Rotate stock and observe shelf life dates. Discard when outdated or damaged. When used, the product must be placed into use following accepted surgical sterile technique. Sterilization. BioMesh® Biodegradable GTR Barrier is supplied "STERILE" and is terminally EtO sterilized in accordance with accepted standards.

FEATURE	BioMesh	Resolut	SE?
Indications for Use:	Two or three wall vertical defects, Class IIfurcations, Circumferrential defects, Recessiontype defects, Dehisence defects associated withdental implants	SAME	YES
Material:	polyglycolic acid with a coating of polylactic acid +polylactic glycolic acid copolymer	Equivalent	YES
Structure:	microporous membrane made of biodegradablepolyglycolide, polylactide and d,l-lactide/glycolidecopolymer. The membrane is made up ofinterconnective pores with an embossed surface.	Non-woven membrane yes, nointerconnecting pores, noembossing	Equivalent
Tissue Integration:	Test result score 115	Test result score 110	YES
Biocompatability:	Good	Good	YES
Toxicity:	Good	Good	YES
Stability:	5 Years	5 Years	YES
Clinical Data:	Good	Good	YES
Manufacturer:	SAMYANG	GORE	YES
Product Code:	LYC	SAME	YES
K - Number:	Pending	K932866, K962624 & K973594	YES

11. Summary Comparison Table:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

OCT 1 0 2007

Samyang Corporation C/O Mr. David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

Re: K990363

Trade Name: BioMesh® Biodegradable GTR Barrier Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPK Dated: December 28, 1998 Received: February 5, 1999

Dear Mr. Schlerf:

This letter corrects our substantially equivalent letter of April 9, 1999.

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 (PMA). You may, therefore, market the require approval or on or a 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.

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Page 2 -

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 continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sayite y. Michailous.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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ting Public Ho

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K990363 510(k) Number :_

Device Name(s): BioMesh® Biodegradable GTR Barrier

Intended Use(s) of the Device:

Indications for Use:

BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions:

1. Two or three wall vertical defects.
1. Class II furcations.
1. Circumferrential defects.
1. Recession type defects.
1. Dehisence defects associated with dental implants

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susen Runse

(Division Sign-Off)
Division of Dental. Infection Control,

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

and General Hospital Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional format 1-2-96)

SAMYANG/MESH.DOC

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.