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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, 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. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.

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. The mixed device is supplied sterile, packaged in a PET-G tray or in a disposable plastic syringe. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process.

The provided document, K082672, describes a Special 510(k) submission for a device modification to NovaBone Putty – Bioactive Synthetic Bone Graft. This submission focuses on a change in packaging format (addition of a filled-syringe package) and explicitly states that this modification does not result in a change in the technological characteristics of the device. Therefore, the document does not contain details about acceptance criteria based on performance studies for the device itself, nor does it describe specific studies proving the device meets such criteria.

The submission relies on the substantial equivalence to predicate devices (K060728, K080009, and K041613) and the fact that the core bioactive material and its function remain unchanged. The "study" mentioned is animal testing that demonstrated the absorption of the material, but this appears to be part of the initial characterization of the bioactive glass rather than a performance study related to this specific device modification.

Therefore, many of the requested fields cannot be directly answered from the provided text as they pertain to performance studies that are not detailed in this specialized submission.

Here’s a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in this document. This Special 510(k) is for a packaging modification, not a change in performance criteria. The document asserts that "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects," implying it continues to meet the acceptance criteria established for its predicate devices, but these specific criteria are not detailed here.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months."

• Sample Size: Not specified for the animal testing.
• Data Provenance: Animal testing (species not specified). Retrospective in the context of this specific 510(k) submission, as it refers to prior testing of the material.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document does not describe a clinical study or expert review panel for establishing ground truth for device performance in the context of this submission.

4. Adjudication Method

Not applicable. No clinical or expert review study is detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an imaging or diagnostic device that would typically undergo MRMC studies.

6. Standalone Performance (Algorithm Only without Human-in-the-loop performance)

Not applicable. This is a medical implant, not a software algorithm.

7. Type of Ground Truth Used

For the mentioned animal testing related to material absorption:

• Ground Truth: Biological observation of material absorption and replacement with bone tissue in an animal model.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning or AI device.

Summary of available information related to the device modification:

The Special 510(k) submission K082672 is primarily focused on a packaging modification (adding a filled-syringe format) for the NovaBone Putty. The submission explicitly states:

• "This device modification does not result in a change in technological characteristics of the device."
• "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects."

This indicates that the safety and effectiveness were established in prior submissions (K060728, K080009, K041613) for the predicate devices, and this specific submission does not introduce new performance studies or acceptance criteria for the device's function as a bone graft. The animal testing mentioned about material absorption ("majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months") serves as part of the foundational characterization of the bioactive glass material, rather than a performance study for this specific device modification.

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