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NovaBone Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, 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 is a one-component resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate designed specifically for its absorbability and osteoconductive nature. NovaBone is progressively resorbed and replaced by new bone tissue during the healing process. The device is designed as an osteoconductive space-filling particulate device to be gently packed into defect sites and used as a non-structural scaffold for the body's natural healing and bone regeneration process. The device acts as a particulate, synthetic, inorganic, biocompatible and osteoconductive material. The NovaBone device is a single-phase bioactive glass (45S5 Bioglass) particulate device.

This 510(k) submission (K052494) for NovaBone - Resorbable Bone Graft Substitute is not for an AI/ML powered device. The document describes a synthetic resorbable bone graft material. Therefore, the requested information regarding acceptance criteria and performance studies for an AI device, including sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for training, cannot be provided based on the given text.

The document focuses on the material characteristics of the bone graft substitute and its biological interaction with bone tissue, rather than on any AI/ML driven diagnostic or treatment algorithms. The "study that proves the device meets the acceptance criteria" refers to in vivo and in vitro studies demonstrating osteoconductive and osteostimulative properties, which are not relevant to the performance metrics typically associated with AI/ML medical devices.

Summary of available information from the document (not directly addressing AI/ML criteria):

• Device: NovaBone - Resorbable Bone Graft Substitute
• Purpose of Submission: To expand product claims to cover "osteostimulative" properties.
• Studies Mentioned:
  • In vivo study: Supported a superior rate of osteoconduction and bone formation at early post-implantation periods compared to hydroxyapatite devices.
  • In vitro cell culture studies: Demonstrated and defined the osteostimulative nature, evidenced by increased DNA content and elevated osteocalcin and alkaline phosphatase levels in osteoblast cell cultures.
• Conclusion: NovaBone functions as a bone void filler for non-structural osseous defects. The studies presented supported its osteoconductive and osteostimulative properties.

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