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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.

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

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.

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