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ALLOMATRIX® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

ALLOMATRIX® Putty is a combination of Human Demineralized Bone Matrix (DBM) with a binding medium of calcium sulfate and carboxymethylcellulose.

ALLOMATRIX® Putty comes in the form of a kit with a premeasured powder, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.

This submission discusses the ALLOMATRIX® Putty, a bone void filler. The provided text, however, does not contain information about acceptance criteria, a study proving device performance against those criteria, or the details of such a study as requested in your prompt.

The document primarily focuses on:

• Device Description and Intended Use: Explaining what the ALLOMATRIX® Putty is and where it's used (bony voids or gaps in extremities and pelvis).
• Substantial Equivalence: Stating that the device is substantially equivalent to a predicate device.
• Osteoinductivity Potential: Describing how the osteoinductivity potential of the demineralized bone matrix (DBM) component is assessed in vitro using an immunoassay as a surrogate marker and correlated with an athymic rat model. It explicitly states that it is unknown how this surrogate immunoassay will correlate with human clinical performance.
• Regulatory Clearance: The FDA's letter granting 510(k) clearance based on substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or clinical performance metrics for this device based on the provided text. The document indicates that safety and effectiveness are supported by "substantial equivalence information and testing results provided within this Premarket Notification," but these specific results and criteria are not detailed in the given extract.

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