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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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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 (ridge maintenance/augmentation, implant preparation/ sites 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 (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 either 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 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 (K091484) is a Special 510(k) for a device modification involving a change in package format for NovaBone Dental Putty – Bioactive Synthetic Bone Graft. It is not a clinical study report and therefore does not contain the information requested regarding acceptance criteria and device performance data from a study.

Specifically, the document focuses on demonstrating substantial equivalence of a new syringe package format to existing predicate devices, rather than presenting a study design with acceptance criteria and results. The content states that the "device modification does not result in a change in technological characteristics of the device" and that "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects," implying reliance on prior clearances and the predicate device's established safety and effectiveness.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or grand truth details from this specific document. These types of details would typically be found in a clinical study report or a more comprehensive premarket submission that involves new performance claims requiring clinical validation.

Ask a specific question about this device

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, bioactive, 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 (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. 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.

The provided text is a 510(k) summary for NovaBone Dental Putty, a bioactive synthetic bone graft. It describes the device, its intended use, technological characteristics, warnings, precautions, complications, and a conclusion stating its substantial equivalence to predicate devices. However, the document does NOT contain information about specific acceptance criteria or a dedicated study with performance metrics in the format requested.

The document states: "In vivo performance data were presented. Additional supporting in vitro data were supplied." implying that studies were conducted and results were provided to the FDA as part of the 510(k submission), but these specific results, acceptance criteria, sample sizes, ground truth establishment, or expert involvement are not detailed within this summary.

Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text.

Here's what can be inferred or explicitly stated based on the text for the questions that can be answered:

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

• Cannot be provided from the given text. The document states "In vivo performance data were presented. Additional supporting in vitro data were supplied," but does not detail the acceptance criteria or reported performance results.

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

• Cannot be provided from the given text. The text only mentions "In vivo performance data were presented" without details on sample size, study design (retrospective/prospective), or 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)

• Cannot be provided from the given text. No information about experts or ground truth establishment for a test set is included.

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

• Cannot be provided from the given text. No information about adjudication methods is included.

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

• Not applicable. This device is a bone graft product, not an AI diagnostic tool that would involve human readers or comparative effectiveness studies of AI assistance.

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

• Not applicable. This device is a bone graft product, not an algorithm.

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

• Cannot be explicitly stated from the given text for "ground truth". However, for a bone graft, "in vivo performance data" would typically involve histological analysis (pathology) of bone formation, imaging, and potentially outcomes data related to healing and defect fill, but this is not explicitly detailed as "ground truth" or how it was established.

8. The sample size for the training set

• Not applicable / Cannot be provided from the given text. As this is a medical device (bone graft) and not an AI/ML algorithm, there isn't a "training set" in the computational sense. The "in vivo performance data" mentioned would be analogous to clinical/pre-clinical study data.

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

• Not applicable / Cannot be provided from the given text. Similar to point 8, there's no concept of a "training set" for establishing ground truth in the context of this device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than detailing a specific clinical study with explicit acceptance criteria and performance metrics against a defined ground truth, which is common for AI/ML device submissions.

Ask a specific question about this device