Collagen Dental Sponge Membranes are intended for use in patients with moderate to Sollagen Bontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.

Device Description

Description of the Dore." Conagen Domar Sponge recemsnufactured from crosslinked type I collagen derived from bovine Achilles tendon. The product is supplied sterile, non-pyrogenic, and for single use only.

AI/ML Overview

This submission (K033729) is for a Collagen Dental Sponge Membrane, a medical device. The provided documents are a 510(k) Summary of Safety and Effectiveness and the FDA's decision letter. These documents do not contain information about acceptance criteria or a study proving that the device meets them in the way typically expected for performance claims (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).

Instead, this submission is for a material (Collagen Dental Sponge Membranes) and focuses on demonstrating substantial equivalence to predicate devices by assessing its safety and technical characteristics. The "acceptance criteria" here are implicitly the regulatory requirements for showing substantial equivalence.

Here's how to interpret the available information in the context of your request:

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

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device must pass applicable biocompatibility tests.	The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.
Substantial Equivalence: Device must have similar intended use, material, source, sterilization, etc., to predicate devices.	Collagen Dental Sponge Membranes and its predicates have similar technological characteristics with respect to intended use, material, source, sterilization, etc.
Absence of new safety/effectiveness questions: Device must not raise new questions of safety or effectiveness compared to predicates.	Not explicitly stated as "met," but implied by the conclusion of substantial equivalence.
Intended Use: Consistent with predicate devices.	The device's indications for use: "Collagen Dental Sponge Membranes are intended for use in patients with moderate to severe periodontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery." This matches discussions about similar intended uses to predicates.

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

This information is not provided in the document. For device submissions focused on substantial equivalence based on material properties and biocompatibility, human clinical "test sets" in the context of diagnostic performance are typically not required unless there are novel claims or significant differences from predicates. The "test set" here refers to the samples used for the ISO 10993-1 testing.

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)

This information is not provided. The "ground truth" for biocompatibility testing (ISO 10993-1) is established by the standardized test methods themselves, which are performed by trained laboratory personnel. There is no mention of clinical experts establishing ground truth for a test set in this context.

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

This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective outcomes, which are not detailed 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which this Collagen Dental Sponge Membrane is not.

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

No, a standalone algorithm performance study was not done. This device is a bio-material, not an algorithm.

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

For the safety evaluation, the "ground truth" was established by standardized laboratory testing protocols (ISO 10993-1) for biocompatibility. These tests assess parameters like cytotoxicity, sensitization, irritation, etc., against predefined pass/fail criteria within the standard.

8. The sample size for the training set

This information is not provided. "Training set" is a concept for machine learning models, which is not applicable to this device submission.

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

This information is not applicable as there is no training set for an algorithm.

In Summary:

The provided documents describe a 510(k) submission for a Collagen Dental Sponge Membrane. The "study" referenced is the biocompatibility testing according to ISO 10993-1, which serves as the evidence for the device's safety. The "acceptance criteria" are the predefined pass/fail thresholds within these ISO standards. The overall goal of the submission is to demonstrate substantial equivalence to existing predicate devices, rather than to prove performance against clinical outcome metrics through a typical clinical trial with human subjects. Thus, many of the questions related to AI/diagnostic device evaluation are not applicable here.

Summary

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MAR 1 7 2004

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510(k) Summary of Safety and Effectiveness

Applicant Name and Address: Collagen Matrix, Inc.	509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACDirector, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	March 11, 2004
Device Common Name:	Collagen Dental Sponge Membranes
Device Trade Name:	To be determined
Device Classification Name:	Bone filling augmentation materialUnclassifiedLYC
Predicate Device(s):	Collagen Dental Membrane, K011695Collagen Periodontal Membrane, K003339

Description of the Device

Indications for Use

Thurculous for 'Co Conagen Donal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.

Summary/Comparison of Technical Characteristics

Sullagen Dental Sponge Membranes and its predicates have similar technological characteristics. In particular, the Collagen Dental Sponge Membranes and their enaracteristics. In particles pect to intended use, material, source, sterilization, etc.

Safety

Collagen Dental Sponge Membranes have been evaluated by a number of tests to assess Conagen Doman oponge .ye. The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.

Conclusion

Conclusion The results of the will of the Sponge Membranes are safe and substantially equivalent to its predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 2004

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

Re: K033729

Trade/Device Name: Collagen Dental Sponge Membrane Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: January 26, 2004 Received: January 27, 2004

Dear Ms. Hansen:

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 -Ms. Hansen

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

foc

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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Indications for Use

510(k) Number (if known): ____K033729

Collagen Dental Sponge Membranes Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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

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

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510(k) Number: K033729

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.