Simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; covering of implants placed in immediate extraction sockets; covering of implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; covering of bone defects after root resection; cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal and recession defects.

Device Description

MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.

AI/ML Overview

The provided text is a 510(k) summary for the MUCOGRAFT® Collagen Matrix, focusing on establishing substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance data for a new device.

Therefore, many of the requested sections about acceptance criteria, study details, expert consensus, and ground truth establishment cannot be fully answered based on the provided document. The document primarily compares the new MUCOGRAFT® Collagen Matrix to its predicate device (MUCOGRAFT® Resorbable Bilayer Membrane) based on existing characteristics and manufacturing changes, not new performance data.

Here's what can be extracted and what information is missing:

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

The document does not explicitly state acceptance criteria in the context of a performance study for the new MUCOGRAFT® Collagen Matrix beyond maintaining the characteristics of its predicate. Instead, it compares the characteristics of the proposed device to the predicate device.

Characteristic	Acceptance Criteria (from Predicate)	Reported Device Performance (New MUCOGRAFT® Collagen Matrix)
Intended Use	Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.	Used for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
Incorporates Same Basic Design	Yes	Yes
Utilizes Same Operating Principle	Cell occlusive, Implantable, Resorbable, Hemostatic	Cell occlusive, Implantable, Resorbable, Hemostatic
Incorporates Same Materials?	Yes, Type I and Type III Collagen, Same Amount	Yes, Type I and Type III Collagen, Same Amount
Sterilization Process	Gamma Irradiation	Gamma Irradiation
Biocompatible	Yes	Yes
Non-pyrogenic	Yes	Yes
Shelf Life	36 Months	36 Months
Thickness (dry)	Approx. 2 mm	Approx. 2.5-5 mm
Thickness (when placed over defect)	Approx. 1 mm	Approx. 1 mm

Note on "Acceptance Criteria": In this context, the "acceptance criteria" are implied by the substantial equivalence argument – the new device must demonstrate similar characteristics to the predicate device to be considered equally safe and effective. The "reported device performance" are the characteristics of the new device that align with or are minor variations of the predicate.

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

Not explicitly provided. The document refers to "all data submitted in the previous notification and clearance of BIO-GIDE® (K042197) and MUCOGRAFT® Resorbable Bilayer Membrane (K061244)." This indicates reliance on previously cleared data, not new, specific performance study data for the new MUCOGRAFT® Collagen Matrix.

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 provided. The document does not describe a study involving expert assessment of a test set to establish ground truth for the new device. The substantial equivalence argument relies on the inherent properties and established safety/efficacy of the predicate devices.

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

Not applicable/Not provided. There is no described test set or adjudication method.

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 document describes a medical device (collagen matrix) for guided tissue and bone regeneration, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study or AI-related effectiveness is irrelevant.

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

Not applicable. As above, this is not an AI algorithm.

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

Implied ground truth: The "ground truth" for the substantial equivalence claim is the established safety and efficacy of the predicate devices (MUCOGRAFT® and BIO-GIDE®) based on their previous clearances (K012423, K061244, K960724, K042197, K050446). This would have likely involved a combination of biocompatibility testing, mechanical testing, and potentially animal or clinical outcomes data for those predicate devices, but these details are not provided for the current submission.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI system, so there is no training set in that sense. If "training set" refers to data used to initially establish the predicate devices, that is not detailed here.

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

Not applicable/Not provided. As above, this is not an AI system.

Summary

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510(k) Summary

: .

MUCOGRAFT®

MAY 3 0 2008

SPONSOR 1.

Ed. Geistlich Soehne Ag für Chemische Industrie Geistlich Pharma Ag-Bahnhofstrasse 40 CH-6110 Wolhusen SWITZERLAND

Contact Person: Peter S. Reichertz, (202) 772-5333 Date Prepared: May 22, 2008

2. · DEVICE NAME

Proprietary Name	MUCOGRAFT® Collagen Matrix
Common/Usual Name:	Resorbable Bilayer Membrane for Guided Tissue and BoneRegeneration
Classification Name:	Barrier, Animal Source, Dental

3. PREDICATE DEVICES

MUCOGRAFT® (K012423 and K061244) BIO-GIDE® (K960724; K042197; and K050446)

4. INTENDED USE

MUCOGRAFT® Collagen Matrix is recommended for:

Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; ー
ﺴﺘ Covering of implants placed in immediate extraction sockets;
-Covering of implants placed in delayed extraction sockets:
ー Localized ridge augmentation for later implantation:
-Alveolar ridge reconstruction for prosthetic treatment;
-Covering of bone defects after root resection, cystectomy, removal of retained teeth;
. Guided bone regeneration in dehiscence defects; and
Guided tissue regeneration procedures in periodontal and recession defects. -

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DEVICE DESCRIPTION 5.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

MUCOGRAFT® collagen matrix is substantially equivalent to Geistlich's existing products MUCOGRAFT® resorbable bilayer membrane (K012423 and K061244) and BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration (subject to K960724; K042197; and K050446). The differences between the new product and the BIO-GIDE and MUCOGRAFT® products cleared previously via K061244 and K042197, respectively, are the following: (1) changes to the manufacturing process, including a change in the concentration and duration of the alkaline treatment step, a new freeze-dryer, and the solvent cleaning phase being performed earlier in the process; (2) a change in the blister material from polystyrene (PS) to amorphic polyethylene terephtalate (A-PET); (3) changes to the product specifications, including a parametric release for the Gamma-Sterilization, and the omission of certain release controls; (4) expanded indication for use in Guided Tissue Regeneration; (5) a new-layout for the product label and packaging; and (6) the thickness of membrane when dry is 2.5 mm to 5 mm as opposed to 2 mm with MUCOGRAFT® Resorbable Bilayer Membrane, but when wet and placed into a defect, both are approximate 1 mm. The proposed additional indication is for "guided tissue regeneration procedures in periodontal defects." Included by reference are all data submitted in the previous notification and clearance of BIO-GIDE® (K042197) and MUCOGRAFT® Resorbable Bilayer Membrane (K061244).

MUCOGRAFT®, like BIO-GIDE®, is a collagen membrane used in dental grafting, procedures. MUCOGRAFT® was previously determined to be substantially equivalent to BIO-GIDE® and is cleared for all of the indications for which BIO-GIDE® is cleared.

The following is a table comparing MUCOGRAFT® Collagen Matrix to MUCOGRAFT® Resorbable Bilayer Membrane for guided tissue and bone regeneration.

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Table 1: MUCOGRAFT® Resorbable Bilayer Membrane (Predicate Device) vs. MUCOGRAFT® Collagen Matrix Comparison Chart

	MUCOGRAFT® ResorbableBilayer Membrane	MUCOGRAFT®Collagen Matrix
Intended Use	Used for guided tissueregeneration procedures inperiodontal defects to enhanceregeneration of the periodontalapparatus.	Used for guided tissueregeneration procedures inperiodontal defects to enhanceregeneration of the periodontalapparatus.
Incorporates Same Basic Design	Yes	Yes
Utilizes Same Operating Principle	Cell occlusiveImplantableResorbableHemostatic	Cell occlusiveImplantableResorbableHemostatic
Incorporates Same Materials?	Yes, Type I and Type IIICollagenSame Amount	Yes, Type I and Type IIICollagenSame Amount
Sterilization Process	Gamma Irradiation	Gamma Irradiation
Biocompatible	Yes	Yes
Non-pyrogenic	Yes	Yes
Shelf Life	36 Months	36 Months
Thickness (dry)	Approx. 2 mm	Approx. 2.5-5 mm
Thickness (when placed overdefect)	Approx. 1 mm	Approx. 1 mm

W02-EAST:9DMS1\200050430.1

and the comments of the comments of

- - - - -1. 1. 1. 1.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAY 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ed. Geistlich Soehne Ag Für Chemische Industrie C/O Mr. Peter S. Reichertz Sheppard, Mullin, Richter & Hampton LLP 1300 I Strect, N.W., 11th Floor East Washington, DC 20005

Re: K073711

Trade/Device Name: MUCOGRAFT® Collagen Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: May 22, 2008 Received: May 23, 2008

Dear Mr. Reichertz:

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.

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Page 2 -- Mr. Reichertz

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), please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

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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K073711

Indications for Use

510(k) Number (if known): K073711

Device Name:

MUCOGRAFT® Collagen Matrix.

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 801 Subpart C)

Susan Runore

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number.

K073711

W02-EAST:9EJJ1\200052247.1

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.