FortaGen Oral Membrane is intended to be used during guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures as a biodegradable barrier membrane for:

Ridge augmentation for later implant insertions;
. Simultaneous ridge augmentation and implant insertions;
. Ridge augmentation around implants inserted in delayed extraction sites;
. Ridge augmentation around implants inserted in immediate extraction sites;
. Alveolar ridge preservation consequent to tooth (teeth) extraction(s);
Over the window in lateral window sinus elevation procedures; .
. In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved;
. In intra bony defects around teeth;
. For treatment of recession defects, together with coronally positioned flap;
. In furcation defects in multi-rooted teeth.

Device Description

FortaGen Oral Membrane consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied hydrated in sheet form in sizes ranging from 13 mm x 25 mm to 40 mm x 50 mm in sterile double layer peelable packaging.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the FortaGen Oral Membrane. This document focuses on demonstrating substantial equivalence to pre-existing devices rather than outlining specific acceptance criteria and a detailed study proving performance against those criteria.

Therefore, many of the requested sections (Table of acceptance criteria, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) cannot be fully addressed from the provided text.

Here's an analysis based on the available information:

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

The document does not explicitly state a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on technological characteristics and performance data. The reported "performance" is qualitative, asserting similarity to existing devices.

Acceptance Criteria Category	Reported Device Performance (FortaGen Oral Membrane)
Biocompatibility	"FortaGen Oral Membrane has been shown to be biocompatible."
Resorption Profile	"designed to resorb within six months. Its handling characteristics and resorption profile are substantially equivalent to those of its predicate devices."
Handling Characteristics	"Its handling characteristics and resorption profile are substantially equivalent to those of its predicate devices."
Equivalency to Predicates	"should function equivalently to Ossix-Plus and Bio-Gide when used as intended for GTR and GBR procedures."
Material/Composition	"consists of a multi-laminate sheet predominantly of Type I porcine collagen." (Matches predicate's collagen-based nature).

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

The document does not describe a specific "test set" in the context of a clinical study with a defined sample size. The substantial equivalence argument appears to be based on pre-clinical data (biocompatibility) and material characteristics, implicitly compared against established knowledge of the predicate devices. No information on data provenance (country of origin, retrospective/prospective) is provided in relation to a formal test set.

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. The document does not describe a clinical study with a "test set" requiring expert-established ground truth. The demonstration of equivalence primarily relies on material science and manufacturing process attributes, and general biological function.

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

Not applicable, as no described test set requiring adjudication is present.

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 device is a resorbable dental barrier membrane, not an AI software or diagnostic imaging device that would involve human readers or AI assistance.

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

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

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

The "ground truth" for the FortaGen Oral Membrane appears to be based on:

Material properties and composition: Verified through standard material characterization tests to confirm it's primarily Type I porcine collagen.
Biocompatibility: Demonstrated through standard biocompatibility testing methods (likely in-vitro and/or in-vivo animal studies, although specific details are not provided in this summary).
Resorption profile: Assessed through in-vitro or in-vivo studies (likely animal models) to determine the timeframe for resorption.
Handling characteristics: Likely evaluated during manufacturing and potentially in pre-clinical settings.
The "truth" is that these characteristics are "substantially equivalent" to predicate devices, which are already accepted as safe and effective.

8. The sample size for the training set

Not applicable. This refers to training data for algorithms, which is not relevant for this physical device.

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

Not applicable. This refers to ground truth for training data for algorithms, which is not relevant for this physical device.

Summary

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Image /page/0/Picture/2 description: The image shows a handwritten string of characters, which appears to be a code or identifier. The string reads 'K0715555'. The characters are written in a clear, legible style, with distinct strokes that make each character easily identifiable. A horizontal line is present beneath the string of characters.

Image /page/0/Picture/3 description: The image shows a handwritten number that appears to be "182". The numbers are written in a cursive style, with the "1" and "8" clearly visible. There is a line underneath the number, possibly indicating it is part of a calculation or a label.

5. 510(k) Summary

Submitted by:

Organogenesis, Inc. 150 Dan Road Canton, MA 02021 AUG 3 0 2007

Contact:

Patrick R. Bilbo Telephone: 781-401-1155 Facsimile: 781-401-1288

Date: June 6, 2007

Device:

Trade Name: Common/Usual Name: Classification Name: Regulatory Class:

FortaGen® Oral Membrane Resorbable dental barrier membrane, animal source Not applicable Not classified

Predicate Devices:

The device is similar to predicate collagen-based surgical mesh devices and collagen dental membranes previously cleared for commercial distribution. The relevant predicate devices include FortaGen Surgical Mesh (K021105), formerly FortaFlex Surgical Mesh, manufactured by Organogenesis Inc., Ossix-Plus (K053260) manufactured by Colbar LifeScience, Ltd., and Bio-Gide Resorbable Bilayer Membrane (K050446) manufactured by Ed. Geistlich Soehne Ag für Chemische Industrie.

Intended Use:

FortaGen Oral Membrane is intended to be used during guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures as a biodegradable barrier membrane for:

Ridge augmentation for later implant insertions;
. Simultaneous ridge augmentation and implant insertions;
. Ridge augmentation around implants inserted in delayed extraction sites;
. Ridge augmentation around implants inserted in immediate extraction sites;
. Alveolar ridge preservation consequent to tooth (teeth) extraction(s);
Over the window in lateral window sinus elevation procedures; .
. In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved;
. In intra bony defects around teeth;

Confidential

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$\frac{K07/555}{307^{2}}$

. For treatment of recession defects, together with coronally positioned flap;
. In furcation defects in multi-rooted teeth.

Device Description:

Technological Characteristics and Performance Data:

The FortaGen Oral Membrane, like its predicate devices, is manufactured from porcine collagen and is designed to resorb within six months. FortaGen Oral Membrane has been shown to be biocompatible. Its handling characteristics and resorption profile are substantially equivalent to those of its predicate devices, and the FortaGen Oral Membrane should function equivalently to Ossix-Plus and Bio-Gide when used as intended for GTR and GBR procedures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. 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 presented in black and white, giving it a formal and official appearance.

MAY 27 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Patrick R. Bilbo Vice President, Regulatory and Clinical Affairs Organogenesis, Incorporated 150 Dan Road Canton, Massachusetts 02021

Re: K071555

Trade/Device Name: FortaGen Oral Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: August 17, 2007 Received: August 20, 2007

Dear Mr. Bilbo:

This letter corrects our substantially equivalent letter of August 30, 2007.

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. Bilbo

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) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Suite Y. Michie Davis.

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

Enclosure

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K071555
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Indications for Use

510(k) Number (if known): _

Device Name: FortaGen Oral Membrane

Indications for Use:

FortaGen Oral Membrane is intended to be used during guided bone and guided tissue regeneration procedures as a biodegradable barrier membrane for:

Ridge augmentation for later implant insertions; ●
Simultaneous ridge augmentation and implant insertions; .
. Ridge augmentation around implants inserted in delayed extraction sites;
Ridge augmentation around implants inserted in immediate extraction sites; .
. Alveolar ridge preservation consequent to tooth (teeth) extraction(s);
Over the window in lateral window sinus elevation procedures;
. In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved;
In intra bony defects around teeth;
. For treatment of recession defects, together with coronally positioned flap;
In furcation defects in multi-rooted teeth. .

Prescription Use __ X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susy Runoer

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

Page of

510(k) Number: K071555

Confidential

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.