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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.

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.

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."

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.

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