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NovaBone Bioactive Strip bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Bioactive Strip is indicated to be gently placed 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. NovaBone Bioactive Strip must be hydrated with autogenous bone marrow aspirate prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone BIOACTIVE Strip is an osteoconductive bioactive device used for grafting osseous defects. The device is a mixture of bioactive calcium-phosphosilicate granules and a collagen binder. The bioactive glass particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The binder consists of bovine collagen. When hydrated with bone marrow aspirate, the device absorbs fluids to form a flexible graft matrix that is applied directly to the intended graft site. During healing, the graft particulate is absorbed and remodeled into new bone.

BIOACTIVE Strips are flexible after hydration and are not intended to be loadbearing. Therefore, bulk physical /mechanical properties such as compressive and tensile strengths are not applicable to device properties. The device is sterilized to a sterility assurance level of 100 using ethylene oxide.

I am sorry, but the provided text only refers to a medical device's 510(k) premarket notification and its substantial equivalence to predicate devices, focusing on regulatory aspects, material composition, and intended use. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as would be relevant for an AI/ML powered device. Therefore, I cannot fulfill your request to describe those details based on the given document.

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