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NovaBone Putty - Bioactive Synthetic Bone Graft 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, posterolateral spine, 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 not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

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 then are slowly absorbed and replaced by new bone tissue during the healing process. The mixed device is supplied sterile and is packaged in single-use containers in multiple formats.

The device modification of the current submission adds an attachable applicator tip to the NovaBone Putty pre-filled cartridge delivery system (MIS delivery system). The tip provides for more precise control of NovaBone Putty placement.

The provided text is a 510(k) summary for a medical device called "NovaBone Putty - Bioactive Synthetic Bone Graft." It outlines the device, its indications for use, technological characteristics, and a summary of performance testing.

However, the document explicitly states: "Human clinical testing was not conducted or relied upon for determining substantial equivalence for this premarket notification."

This means that the provided document does not contain any information about a study that proves the device meets specific acceptance criteria based on human performance data, clinical outcomes, or expert assessments. The clearance for this device was based on demonstrating substantial equivalence to a predicate device through non-clinical performance evaluations (cytotoxicity, bioburden, and bench tests for mechanical integrity).

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the specific points you raised (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth). The information necessary to answer those questions is not present in the provided text.

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