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NovaBone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process.

This document is a 510(k) premarket notification for the NovaBone Putty - Bioactive Synthetic Graft, indicating that it does not contain acceptance criteria or a study proving that the device meets those criteria.

The document states that "In vivo performance data were presented. Additional supporting in vitro data were supplied" in section 9 "Conclusion". However, the report does not provide the details of these tests, such as the specific acceptance criteria, outcomes, sample sizes, or methods for establishing ground truth.

This document is a regulatory submission for premarket notification, designed to demonstrate substantial equivalence to previously marketed devices. It is not a detailed clinical trial report or a scientific study designed to establish new performance metrics against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

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