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The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

• · Periodontal/Infrabony defects
• · Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
• · Extraction sites (ridge maintenance/augmentation, implant preparation/ placement)
• Sinus lifts
• · Cystic cavities
• · Cranio-facial augmentation

For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

NovaBone Dental Putty is an osteoconductive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. It is composed of a calcium-phosphorussodium-silicate 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 either in a PET-G tray or in a disposable plastic syringe or cartridge. 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. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile.

This document is a 510(k) premarket notification for a device modification, specifically a packaging change, for NovaBone Dental Putty. It does not contain information about acceptance criteria or specific studies proving device performance beyond establishing substantial equivalence to predicate devices. The majority of the document explicitly states that no changes to the device formulation or function have been made and that it does not result in a change in technological characteristics of the device. Therefore, the device relies on the previous clearances of its predicate devices to demonstrate safety and effectiveness.

As such, the information required cannot be fully extracted from the provided text. However, I can explain why certain sections are not applicable or cannot be found based on the provided text.

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. This document is a "Special 510(k): Device Modification Summary" focusing on a packaging change. It explicitly states: "The NovaBone Dental Putty device of this submission is identical in composition to the NovaBone Dental Putty predicate devices; no changes to the device formulation or function have been made." Therefore, new acceptance criteria and performance data for the device itself are not presented, as its performance is assumed to be equivalent to the predicate devices. Acceptance criteria would typically be established during the initial clearance of a device, not for a minor modification like a packaging change.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. Since no new studies are presented to demonstrate device performance (due to the nature of the modification being only a packaging change), there is no test set or related data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document. As mentioned, there is no new test set requiring ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document. There is no test set, thus no adjudication method is relevant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not available in the provided document. The NovaBone Dental Putty is a synthetic bone graft material, not an AI or imaging diagnostic device. Therefore, MRMC studies or AI involvement are not relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not available in the provided document. As stated above, this is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document. There is no new study or data presented that would require established ground truth. The device relies on the existing safety and efficacy data of its predicate devices.

8. The sample size for the training set

This information is not applicable and not available in the provided document. There is no AI model or algorithm being trained for this device.

9. How the ground truth for the training set was established

This information is not applicable and not available in the provided document. There is no AI model or algorithm being trained for this device.

Summary based on the document:

The provided document describes a "Special 510(k)" submission for a modification to an already legally marketed device, NovaBone Dental Putty. The modification consists solely of a new packaging format (a filled-cartridge) to augment existing configurations.

The document explicitly states:

• "The NovaBone Dental Putty device of this submission is identical in composition to the NovaBone Dental Putty predicate devices; no changes to the device formulation or function have been made."
• "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."

Therefore, this 510(k) submission relies on the concept of substantial equivalence to its predicate devices (NovaBone Dental Putty – Bioactive Synthetic Graft [K091484] and [K063549]) to demonstrate its safety and effectiveness. It does not present new studies, acceptance criteria, or performance data because the device itself has not changed technologically. The FDA's letter (K100671) confirms this by stating that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

To find information on acceptance criteria and performance studies for the NovaBone Dental Putty, one would need to review the original 510(k) submissions for the predicate devices (K091484 and K063549), as those would contain the initial safety and efficacy data that established the device's original clearance.

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