Collagen Dental Membrane III is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.

Collagen Dental Membrane III is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.

Device Description

Collagen Dental Membrane III is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane III is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

AI/ML Overview

This submission describes a medical device, Collagen Dental Membrane III, intended for use in dental surgery procedures. It is a resorbable membrane matrix designed to aid in wound healing after dental implant, bone defect, or ridge reconstruction.

Here’s an analysis of the provided text based on your request, highlighting that this is not an AI/ML device and therefore many of your questions are not applicable:

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

Acceptance Criteria (General for device type)	Reported Device Performance (Collagen Dental Membrane III)
Safety/Biocompatibility: Device passed applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for biological evaluation of medical devices.	The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.
Substantial Equivalence: Demonstrated to be substantially equivalent to a legally marketed predicate device (Collagen Dental Membrane, K011695).	The in vitro product characterization studies show the device modification of the Collagen Dental Membrane III is safe and substantially equivalent to the original device. Similar in intended use, material, form, sizes, thickness, physical integrity, permeability and conformability to predicate.

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

This is not an AI/ML device. Therefore, the concepts of "test set," "sample size," and "data provenance" as they relate to AI model evaluation are not applicable here. The evaluation involved biocompatibility testing and comparison to a predicate device.

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

This is not an AI/ML device. "Ground truth" in the context of expert review for AI is not relevant. The evaluation of this device is based on standardized biocompatibility testing protocols and material characterization, not expert human interpretation of data for AI model training or validation.

4. Adjudication method for the test set

This is not an AI/ML device. "Adjudication method" as it applies to resolving discrepancies in expert labeling for AI models is not applicable. The device's safety and equivalence were determined through established regulatory testing and comparison methods.

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

This is not an AI/ML device. Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not conducted and is not relevant to this type of medical device submission.

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

This is not an AI/ML device. No algorithm or standalone performance evaluation was conducted because it is a physical medical device (collagen membrane), not a software or AI product.

7. The type of ground truth used

For this device, the "ground truth" aligns with established scientific and regulatory standards for medical devices:

Biocompatibility: Determined by adherence to FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards (e.g., cytotoxicity, sensitization, irritation tests). The "ground truth" is that the device, when subjected to these tests, does not elicit unacceptable biological responses.
Substantial Equivalence: Determined by demonstrating that the device has the same intended use and similar technological characteristics (material, form, sizes, thickness, physical integrity, permeability, conformability) to a legally marketed predicate device. The "ground truth" for equivalence is the predicate device's established safety and effectiveness profile.

8. The sample size for the training set

This is not an AI/ML device. Therefore, there is no "training set" in the context of machine learning.

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

This is not an AI/ML device. There is no training set for this type of device.

Summary

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K062846

510(k) Summary of Safety and Effectiveness OCT 1 3 2006

Applicant Name and Address: Collagen Matrix, Inc.	509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACSr. Director, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	September 19, 2006
Device Common Name:	Collagen Dental Membrane
Device Trade Name:	Collagen Dental Membrane III
Device Classification Name:	Bone Grafting MaterialClass II872.3930LYC
Predicate Device(s):	Collagen Dental Membrane, K011695

Description of the Device

Intended Use

Summary/Comparison of Technical Characteristics

Collagen Dental Membrane III and its predicate have similar technological characteristics. In particular, the Collagen Dental Membrane III and its predicate are similar with respect to intended use, material, form, sizes, thickness, physical integrity, permeability and conformability.

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K062846

Safety

A Collagen Dental Membrane III equivalent has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

Conclusion

The results of the in vitro product characterization studies show that the device modification of the Collagen Dental Membrane III is safe and substantially equivalent to the original device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

OCT 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

Ms. Peggy Hansen, RAC Senior Director, Clinical, Regulatory and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K062846

Trade Name: Collagen Dental Membrane III Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: September 20, 2006 Received: September 25, 2006

Dear Ms. Hansen:

This letter corrects our substantially equivalent letter of October 13, 2006.

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 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 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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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 80), 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,

Senjie y. Michue
m.D.

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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Protecting and Promoting Public Health

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K062846

Indications for Use

062846 510(k) Number (if known):

Device Name: Collagen Dental Membrane III

Indications for Use:

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

C 10(k) Number:

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Muluy for MSP

on Sign-Off) ision of Anesthesiology, General Hospital, Intection Control, Dental Devices

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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.