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SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 4555 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

The provided text describes the regulatory clearance of a medical device, SIGNAFUSE Bioactive Bone Graft, and not a software-driven AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria, study design for AI/ML performance (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in the provided document.

The document focuses on the substantial equivalence of the SIGNAFUSE Bioactive Bone Graft to existing predicate devices based on its intended use, materials, and performance in a rabbit model.

However, I can extract the information that is relevant to the device's performance assessment as described in the document, which pertains to its biological and physical characteristics rather than an AI/ML algorithm.

Here's what can be inferred about the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific bone graft device:

Acceptance Criteria and Device Performance (for SIGNAFUSE Bioactive Bone Graft - a physical device)

The acceptance criteria for this physical device are primarily related to its biocompatibility, sterility, shelf-life, and in vivo performance (osteoconductivity and resorption) comparable to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance:

• Test Sample Size: Not explicitly stated for the rabbit model. The document mentions "a posterolateral spine fusion rabbit model" and "testing performed in K160446," implying a set of rabbits were used, but no specific count is provided.
• Data Provenance: The study was an in vivo animal study based on a "posterolateral spine fusion rabbit model," indicating animal data. The location/country of the study is not specified in the provided text. It was a comparative study ("in comparison to the MCP Bone Putty predicate device, as well as a control group").

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable / Information not provided. This device is a physical bone graft, not an AI/ML algorithm requiring human expert review for ground truth establishment. The ground truth for its performance is based on in vivo animal histology, imaging, or physical outcomes (e.g., fusion success), evaluated by researchers/veterinarians, not by human radiologists/experts determining image-based diagnoses for an AI.

4. Adjudication Method for the Test Set:

• Not applicable / Information not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for diagnostic accuracy, especially with human readers or AI outputs, where there might be disagreement in interpretations. This is not relevant for the in vivo animal study described for a physical bone graft.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No. An MRMC study is designed to assess the diagnostic performance of human readers, often with and without AI assistance, across multiple cases. This is irrelevant for evaluating a physical medical device like a bone graft.

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

• No. This refers to AI algorithm performance. SIGNAFUSE Bioactive Bone Graft is a physical device, so this question is not applicable.

7. The Type of Ground Truth Used:

• Animal study outcomes: The performance was evaluated using an "established posterolateral spine fusion rabbit defect model (Boden, ASTM F2307-17)." This implies that the ground truth for in vivo performance was based on biological outcomes observed in the rabbits, likely through histological analysis, radiography, or other methods specific to bone fusion assessment in animal models. It is a biological/physiological ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm, therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, there is no "training set" for an AI/ML algorithm.

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