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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, posterolateral 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; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

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. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles then are slowly absorbed and replaced by new bone tissue during the healing process. The mixed device is supplied sterile and is packaged in single-use containers in multiple formats.

The device modification of the current submission adds an attachable applicator tip to the NovaBone Putty pre-filled cartridge delivery system (MIS delivery system). The tip provides for more precise control of NovaBone Putty placement.

The provided text is a 510(k) summary for a medical device called "NovaBone Putty - Bioactive Synthetic Bone Graft." It outlines the device, its indications for use, technological characteristics, and a summary of performance testing.

However, the document explicitly states: "Human clinical testing was not conducted or relied upon for determining substantial equivalence for this premarket notification."

This means that the provided document does not contain any information about a study that proves the device meets specific acceptance criteria based on human performance data, clinical outcomes, or expert assessments. The clearance for this device was based on demonstrating substantial equivalence to a predicate device through non-clinical performance evaluations (cytotoxicity, bioburden, and bench tests for mechanical integrity).

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the specific points you raised (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth). The information necessary to answer those questions is not present in the provided text.

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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, posterolateral 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; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

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 and is packaged in single-use containers in multiple formats. 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.

This 510(k) submission (K110368) is for a modification to an existing device, NovaBone Putty, specifically a change in packaging. Therefore, there are no acceptance criteria or a study detailed in the provided text that "proves the device meets the acceptance criteria" in the way a clinical trial might for a new device's performance.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, asserting that the change in packaging does not alter the device's fundamental characteristics or performance.

Here's an analysis based on your requested information, acknowledging the nature of this particular 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the typical sense for a device performance study. For a packaging modification, the "acceptance criteria" revolve around maintaining the safety, effectiveness, and technological characteristics of the original device. The "reported performance" is that the device itself remains unchanged and functions as intended, with the new packaging being stable and appropriate.

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

Not applicable. This submission is about a packaging change for an already cleared device. There is no "test set" in the context of evaluating a medical AI algorithm or a new therapeutic device's clinical performance. The "data provenance" would relate to the validation of the new packaging, which isn't detailed in this document but would typically involve material compatibility testing, sterility testing, and shelf-life studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No ground truth establishment for a patient-based test set is relevant for a packaging modification.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication process for clinical outcomes described.

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 void filler, not an AI diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of clinical performance ground truth. For a packaging modification, the "ground truth" would be the verified physical and chemical properties of the device and packaging, and their interaction, as determined by laboratory testing and regulatory compliance.

8. The Sample Size for the Training Set

Not applicable. There is no training set for an AI algorithm or a new clinical device being developed from scratch.

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

Not applicable.

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NovaBone Putty 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, posterolateral 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; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

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 disposable plastic syringe with one or more attachable cannula allowing for placement of the putty at a predetermined distance from the 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.

This document is a 510(k) summary for a medical device modification ("NovaBone Putty - Bioactive Synthetic Bone Graft"). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance study comparing a device's effectiveness against predefined metrics.

This submission is specifically for a modification to an already cleared device. The core of the document states that the modification is solely in terms of the device packaging (to permit attachment of an extension cannula) and that "the device itself is unchanged." Therefore, the submission's focus is on demonstrating that this packaging change does not alter the fundamental technological characteristics, safety, or effectiveness of the device.

Here's an analysis based on the provided text, highlighting why a traditional "acceptance criteria" and "study proving device meets acceptance criteria" are not present for this specific submission:

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

Not applicable. This submission is for a packaging modification. There are no performance metrics or clinical acceptance criteria being evaluated or reported for this specific change. The core device's performance was established in prior 510(k) clearances (K060728, K080009, K082672).

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

Not applicable. No "test set" in the context of clinical performance or diagnostic accuracy is described. The submission focuses on the implications of a packaging change.

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)

Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic or efficacy study.

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

Not applicable. No test set for adjudication is described.

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 void filler, not an AI diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. No ground truth in the context of clinical or diagnostic performance is applicable to this documentation.

8. The sample size for the training set

Not applicable. No training set is relevant to this type of device modification.

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

Not applicable.

Summary of Device Modification and How it "Meets" Acceptance (within the context of a 510(k) for modification):

The document explicitly states:

• "The NovaBone Putty device of this submission has been modified from that of the predicate solely in terms of the device packaging; the device itself is unchanged." (Page 1, Section 6)
• "The device action as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow is unchanged." (Page 1, Section 6)
• "This device modification does not result in a change in technological characteristics of the NovaBone Putty device." (Page 1, Section 7)
• "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects." (Page 1, Section 7)

The "study" that proves the device meets the acceptance criteria (in this specific case) is the argument for Substantial Equivalence to the predicate device, K060728, K080009, and K082672.

The acceptance criteria are implicitly that the modified device (packaging change only) retains the same technological characteristics, intended use, safety, and effectiveness as the previously cleared predicate devices. The "proof" is the detailed comparison provided in Section 6, explicitly stating the device itself is unchanged and only the packaging for delivery has been modified to permit the attachment of an extension cannula. This demonstrates that the change does not introduce new questions of safety or effectiveness.

The FDA's letter (Page 2) confirms this by stating: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This determination by the FDA serves as the "proof" that the device modification meets the necessary regulatory acceptance criteria for substantial equivalence.

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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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