The Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

Long bones .
Flat bones t
Short bones
Irreqular bones .
Appendicular skeleton
Thorax .

When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving:

Tumor resections where bone strength has not been compromised .
. lliac crest harvests

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Device Description

The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The Collagen Bone Healing Protective Sheet can be cut with scissors to the desired shape and size. The Collagen Bone Healing Protective Sheet is fully conformable when hydrated and can conform three dimensionally to most any anatomical orientation. The Collagen Bone Healing Protective Sheet can be rolled into a tube or used as a flat sheet. The Collagen Bone Healing Protective Sheet can be used cither alone or in conjunction with internal bonc fixation devices such as plates and screws, which also can scrve to further stabilize the anatomical region.

The Collagen Bone Healing Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The thickness of the Collagen Bone Healing Protective Shect ranges from 0.5 mm to 2.0 mm according to the orthopedic region to be treated. The Collagen Bone Healing Protective Sheet consists of micropores <0.008 um and is provided with or without the addition of macropores in the range of 500 um. Collagen Bone Healing Protective Shect is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the "Collagen Bone Healing Protective Sheet." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be seen for a novel or high-risk device.

Therefore, many of the requested elements for acceptance criteria and a study proving those criteria are not available or applicable in this document.

Here's an analysis based on the information provided:

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

Not Applicable / Not Provided. The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of technical characteristics (material, form, sizes, thickness, physical integrity, mechanical strength, porosity, and in vivo stability) and intended use. Performance is implicitly accepted if these characteristics are comparable and safety/biocompatibility is established.

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

Not Provided. This document does not describe specific testing with a "test set" in the context of clinical performance evaluation (e.g., diagnostic accuracy, treatment efficacy) as would be relevant for software or more complex devices. The safety assessment mentions biocompatibility testing, but details on sample sizes or data provenance for that are not included in this summary. The "animal and clinical literature reviews" are mentioned, implying a synthesis of existing data rather than a new, dedicated study with a specific 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 / Not Provided. Given the nature of a 510(k) for a collagen sheet, there is no "ground truth" establishment in the context of diagnostic interpretation or clinical outcomes by expert consensus as might be seen for an AI diagnostic device. The evaluation is based on technical characteristics and biological response.

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

Not Applicable / Not Provided. No adjudication method is described as there isn't a "test set" requiring expert review and adjudication in this context.

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 biomaterial (collagen sheet), not an AI-assisted diagnostic or treatment device. Therefore, an MRMC study is not relevant.

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

Not Applicable. As above, this is a biomaterial, not an algorithm.

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

The document refers to "animal and clinical literature reviews" providing "compelling support for the use of the Collagen Bone Healing Protective Sheet in containing bone graft material and bony fragments in bone defects." This suggests that the "ground truth" or evidence for clinical utility is derived from existing scientific literature and clinical experience with similar materials. For safety, biocompatibility testing (in accordance with FDA's Blue Book Memorandum G95-1 and ISO 10993-1) served as the primary evidence.

8. The sample size for the training set

Not Applicable / Not Provided. There is no "training set" in the context of machine learning for this device. The development of the device would rely on material science research, preclinical testing, and potentially existing clinical data from predicate devices or similar materials.

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

Not Applicable / Not Provided. As there is no "training set" in the ML sense, this question is not applicable. The design and intended use are based on established biomedical principles and comparison to predicate devices, not on a data-driven training process.

Summary of Relevant Information from the Document:

Device Description:
The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It comes in various sizes (20x20mm to 120x120mm) and thicknesses (0.5mm to 2.0mm), with micro- and optional macropores. It is supplied sterile, non-pyrogenic, and for single use.

Intended Use:
The device is intended to:

Maintain the relative position of weak bony tissue (bone grafts, bone graft substitutes, or bone fragments from comminuted fractures).
Cement restriction in total joint arthroplasty procedures.

Specific uses with traditional rigid fixation:

Trauma and reconstructive orthopedic procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax.

Specific uses alone (without traditional rigid fixation):

Maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving tumor resections (where bone strength is not compromised) and iliac crest harvests.

Contraindications/Limitations:

Not intended for use in the spine.
Not intended for load-bearing indications unless used with traditional rigid fixation.

Basis for Substantial Equivalence (and implied "acceptance"):

Comparable Technical Characteristics: The Collagen Bone Healing Protective Sheet is stated to be comparable to predicate devices in "key aspects of the device such as material, form, sizes, thickness, physical integrity, mechanical strength, porosity and in vivo stability."
Identical Intended Use: The indication for use is stated to be "the same as that of its predicate devices."
Safety/Biocompatibility: Supported by testing performed in accordance with FDA's Blue Book Memorandum G95-1 and ISO 10993-1 Biological Evaluation of Medical Device.
Literature Support: "The animal and clinical literature reviews provide compelling support for the use of the Collagen Bone Healing Protective Sheet in containing bone graft material and bony fragments in bone defects."

In conclusion, this 510(k) summary demonstrates substantial equivalence to predicate devices rather than providing a detailed study with explicit performance acceptance criteria and outcomes for a novel clinical claim.

Summary

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K052041

Dean Lab

0C1 25 2005

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:	October 25, 2005
Device Common Name:	Collagen Bone Healing Protective Sheet
Device Trade Name:	To be determined
Device Classification Name:	Plate, Fixation, BoneClass II888.3030HRS	Mesh, SurgicalClass II878.3300FTM	Cement ObturatorClass II878.3300LZN
Predicate Device(s):	Collagen Dental Membrane, K011695BioGide®, K960724EBI LactoSorb® Graft Containment System, K033918MacroPoreOS Protective Sheet, K994158

Description of the Device

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Haskell
Page 2 of 2

Healing Protective Shect is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

Intended Use

Long bones .
Flat bones �
Short bones .
Irregular bones .
Appendicular skeleton .
Thorax .

When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:

Tumor resections where bone strength has not been compromised .
Iliac crest harvests .

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

Summary/Comparison of Technical Characteristics

The indication for use of the Collagen Bone Healing Protective Sheet is the same as that of its predicate devices. The technical charactcristics of the Collagen Bone Healing Protective Sheet are comparable to the predicate devices in key aspects of the device such as material, form, sizes, thickness, physical integrity, mechanical strength, porosity and in vivo stability. The animal and clinical literature reviews provide compelling support for the use of the Collagen Bone Healing Protective Sheet in containing bone graft material and bonv fragments in bone defects.

Safety

The safety/biocompatibility of the Collagen Bone Healing Protective Sheet is supported by the biocompatibility testing performed in accordance with FDA's Blue Book Memorandum G95-1 and ISO 10993-1 Biological Evaluation of Medical Device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted as a stylized design with three lines forming the shape of a bird or wing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

OCT 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Peggy Hansen, RAC Director, Clinical, Regulatory & Quality Assurance Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K052041

Trade/Device Name: Collagen Bone Healing Protective Sheet Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, FTM, LZN Dated: July 27, 2005 Received: July 29, 2005

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 is 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.

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Page 2- Peggy Hansen, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This leter will and in yours of substantial equivalence of your device to a legally prematics notification. The 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 If you dealer specific darioliance 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 other general miorination on Joan 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,

Mark N. Melkerson
Acting Director

Acting 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):	K052041
---------------------------	---------

Collagen Bone Healing Protective Sheet Device Name:

Indications for Use:

The Collagen Bone Healing Protective Sheet is intended to maintain the relative position rfic Ookugon Bone Houne grafts, bone graft substitutes, or bone fragments from or would bony «coures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures.

Long bones .
Flat bones t
Short bones �
Irreqular bones .
Appendicular skeleton �
Thorax .

Tumor resections where bone strength has not been compromised .
. lliac crest harvests

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

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)

200

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

Page 1 of _ 1

510(k) Number_ LO 5 2041

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.