Collagen Dental Membrane V is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Device Description

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

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called "Collagen Dental Membrane V." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through clinical studies in the way a new drug or novel high-risk device might. The information requested aligns with the evaluation of AI/ML-driven medical devices, which often involve performance metrics, ground truth establishment, and clinical study designs.

However, the provided document does not contain the information requested for AI/ML device studies. This 510(k) summary focuses on the safety and substantial equivalence of a resorbable collagen membrane to existing predicate devices based on in vitro and animal studies, not on the performance of a diagnostic or assistive AI system.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study sizes, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device, as this information is not present in the provided context.

The document indicates:

Safety Evaluation: Collagen Dental Membrane V was evaluated in various in vitro and in vivo tests to assess its safety/biocompatibility. It passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.
Substantial Equivalence: The device is deemed "substantially equivalent" to predicate devices (Collagen Dental Membrane IV and Bio-Gide™ Resorbable Bilayer Membrane) based on similar intended use, form, animal source, sizes, thickness, physical integrity, permeability, and conformability, as well as the safety evaluation.

There is no mention of:

Acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.)
A "study" in the sense of a clinical trial proving a device meets specific performance criteria against a ground truth.
Any sample sizes for test or training sets, as it's not an AI/ML product.
Expert involvement for ground truth establishment.
Adjudication methods.
MRMC studies or human-in-the-loop performance.
Stand-alone algorithm performance.
Specific types of ground truth (pathology, outcomes data).

In summary, the provided text describes a submission for a traditional medical device (a resorbable collagen membrane) demonstrating safety and substantial equivalence to existing devices, not an AI/ML-driven device with performance criteria against a ground truth.

Summary

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K100156

510(k) Summary of Safety and Effectiveness

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417	AUG 11 2010
Contact Person:	Peggy Hansen, RACVice President, Clinical, Regulatory, QA, and MarketingTel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	January 14, 2010
Device Common Name:	Resorbable Collagen Membrane
Device Trade Name:	Collagen Dental Membrane V
Device Classification Name:	Barrier, animal source, intraoral872.3930NPLClass II
Predicate Device(s):	Collagen Dental Membrane IVK090216Bio-Gide™ Resorbable Bilayer Membrane for GuidedTissue and Bone RegenerationK050446

Description of the Device

Intended Use

Collagen Dental Membrane V is intended for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Summary/Comparison of Technical Characteristics

Collagen Dental Membrane V and its predicates have similar technological characteristics. In particular, the Collagen Dental Membrane V and its predicate are

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Collagen Matrix, Inc. 510(k) Summary of Safety and Effectiveness Collagen Dental Membrane V

K100156

similar with respect to intended use, form, animal source, sizes, thickness, physical integrity, permeability and conformability.

Safety

Collagen Dental Membrane V has been evaluated in a number of in vitro and in vivo 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 and in vivo animal studies show that Collagen Dental Membrane V is safe and substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). 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.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

Re: K100156

Trade/Device Name: Collagen Dental Membrane V Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 22, 2010 Received: July 23, 2010

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 provise vet 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

AUG 1 1 2010

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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 its its accidention and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K 100156

Indications for Use

510(k) Number (if known):

AUG 1 1 2010

Device Name: _Collagen Dental Membrane V

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 Deffice Evaluation a

Kevin Mulvey for MSR

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

510(k) Nur

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.