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TricOs A Resorbable Bone Substitute is indicated for use as a bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. It is indicated for surgically created osseous defects or osseous defects resulting from traumatic injury. TricOs A Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, pelvis). Following placement in bony voids or gaps, TricOs A Resorbable Bone Substitute is resorbed while providing support for the in-growth of bone during the healing process. TricOs A Resorbable Bone Substitute is a bone void filler without initial mechanical properties, therefore rigid fixation techniques are recommended.

TricOs A Resorbable Bone Substitute consists of an inorganic calcium phosphate scaffold that is mixed with a heterologous human fibrin matrix prior to application. The fibrin matrix acts as a binder for the calcium phosphate scaffold, imparting favorable handling characteristics to the product to facilitate the surgical procedure, and acting as a three-dimensional matrix that supports the in-growth of bone.

The provided text is a 510(k) summary for the TricOs A Resorbable Bone Substitute. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or the details of a study with reported device performance in the format requested.

The document discusses "assessment of nonclinical data" and states that "Device performance as a bone void filler of the skeleton system has been verified in animal studies using a rabbit femoral condyles model and through functional and biocompatibility testing." However, this is a very high-level statement and does not provide:

• A table of acceptance criteria
• Specific performance metrics (e.g., sensitivity, specificity, accuracy, or any quantifiable measure of effectiveness)
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, or details of multi-reader multi-case studies or standalone algorithm performance.
• The type of ground truth used beyond "animal studies" or "functional and biocompatibility testing."
• Training set sample size or how ground truth for a training set was established.

This document is focused on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission, rather than presenting a detailed clinical study report or performance evaluation against specific, quantifiable acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a study that proves the device meets those criteria because the necessary information is not present in the provided text.

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