Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.

Device Description

Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are natural, porous bone mineral matrices with and without collagen. The anorganic bone mineral is produced by removal of all organic components from bovine bone. Due to its natural structure, the anorganic bone mineral component of the products is physically and chemically comparable to the mineralized matrix of human bone. The composition of the Anorganic Bone Mineral meets the requirements of ASTM F1581-99 Standard Specification for Composition of Anorganic bone for Surgical Implants. Anorganic Bone Mineral Collagen and Anorganic Bone Mineral Blocks are product extensions that include highly purified fibrillar type I collagen mixed in with the anorganic bone mineral. The product is supplied in granules or blocks, and it is sterile, non-pyrogenic, and for single use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Collagen Matrix Anorganic Bone Mineral Bone Graft Materials. However, it does not contain a typical "acceptance criteria" table or a full study write-up with the level of detail requested in your prompt (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods for ground truth, or MRMC study results). This document is a summary describing the device, its intended use, and a declaration of its safety and effectiveness based on various tests and an animal study, ultimately leading to a substantial equivalence determination by the FDA.

Based on the information available in the provided text, here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it broadly states that the device "passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices" and that its characteristics "meet the design requirements for an effective bone grafting material." The "reported device performance" is summarized as the device being found "safe and substantially equivalent to its predicates."

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Passed all selected FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing.
Design Requirements	Meets the design requirements for an effective bone grafting material.
Substantial Equivalence	Demonstrated to be safe and substantially equivalent to its predicates.

2. Sample Size and Data Provenance for Test Set

Sample Size: The document mentions "an animal study was performed" but does not specify the sample size (e.g., number of animals, specimens).
Data Provenance: The study was an "animal study," implying in vivo data. The document does not specify the country of origin, but the submission is to the US FDA, so the study likely adhered to US regulatory standards for animal studies. It is implicitly a prospective study as it was conducted to verify effectiveness for this specific device.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not provided in the document. The "ground truth" for the animal study would likely be based on histological examination, imaging, and/or mechanical testing post-implantation, interpreted by experts (e.g., veterinary pathologists, orthopedic surgeons), but their number or qualifications are not detailed.

4. Adjudication Method for Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described for this device. The device is a bone grafting material, not an imaging or diagnostic device that would typically involve human readers interpreting results.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study, as typically understood for algorithms without human-in-the-loop, was not conductedor is not applicable. This device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

The ground truth for the effectiveness study was likely based on animal study outcomes, which would typically involve:

Histological evaluation of bone formation and integration.
Radiological assessment of bone healing.
Potentially biomechanical testing of the regenerated tissue.

8. Sample Size for Training Set

This information is not applicable as the device is a physical material being assessed for safety and effectiveness, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

This information is not applicable as the device is a physical material, not an AI/ML algorithm.

Summary

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K06 2200

510(k) Summary of Safety and Effectiveness

FEB 1 3 2007

Applicant Name and Address:	Collagen Matrix, Inc.509 Commerce StreetFranklin Lakes, New Jersey 07417
Contact Person:	Peggy Hansen, RACSr. Director, Clinical, Regulatory, and QATel: (201) 405-1477Fax: (201) 405-1355
Date of Summary:	July 28, 2006
Device Common Name:	Bone Grafting MaterialBone Void Filler
Device Trade Name:	Collagen Matrix Anorganic Bone Mineral Bone GraftMaterials
Device Classification Name:Regulation Number:Device Class:Product Code:	Filler, Bone Void, Calcium Compound888.3045Class IIMQV
Predicate Device(s):	ORTHOSST™ Resorbable Bone Void Filler, K014289VITOSS® Scaffold Synthetic Cancellous Bone VoidFiller, K032409OsteoGuide® Anorganic Bone Mineral Products, K043034

Description of the Device

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....

Intended Use

Summary/Comparison of Technical Characteristics

Collagen Matrix Anorganic Bone Mineral Bone Graft Materials and their predicates have the same technological characteristics. In particular, Collagen Matrix Anorganic Bone Mineral Bone Graft Materials and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.

Safety

Collagen Matrix Anorganic Bone Mineral Bone Graft Materials have been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.

Effectiveness

The characteristics of the Collagen Matrix Anorganic Bone Mineral Bone Graft Materials meet the design requirements for an effective bone grafting material. An animal study was performed to verify substantial equivalence and effectiveness of the product.

Conclusion

The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, and animal study, show that Collagen Matrix Anorganic Bone Mineral Bone Graft Materials are safe and substantially equivalent to its predicates.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2007

Collagen Matrix, Inc. c/o Ms. Peggy Hansen, RAC Sr. Director, Clinical, Regulatory, and Quality Assurance 509 Commerce St. Franklin Lakes, NJ 07417

Re: K062200 -

Device Name: Collagen Matrix Anorganic Bone Mineral Bone Graft Materials Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: November 16, 2006 Received: November 17, 2006

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.

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

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Page 2 - Ms. Peggy Hansen, RAC

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchins

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Anorganic Bone Mineral Bone Graft Materials are intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) that are not intrjwic to the stability of the bony structure. These defects may be surgically created osseous. defects or osseous defects resulting from traumatic injury to the bone.

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)

Barbere Brechun

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number Kole 2200

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.