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OsteoGraf/N-300 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.

The OsteoGraf/N-300 material is a natural, high purity, radiopaque, polycrystaline hydroxylapatie, the major mineral phase of bone and dental enamel. It is manufactured as an anorganic, rounded irregular shaped bovine-derived hydroxylapatite particles, sized at 250-420 microns.

The provided text does not contain information regarding a device that requires acceptance criteria and a study to prove it meets acceptance criteria in the way described in your request (e.g., performance metrics, ground truth, expert opinions, etc.).

The document is a 510(k) summary for a bone grafting material called OsteoGraf/N-300. The regulatory review for this type of device primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than performance against specific analytical or clinical acceptance criteria as would be typical for an AI/ML-driven device or a diagnostic device.

The 510(k) summary states:

• "All of the components found in OsteoGraf/N-300 have been used in legally marketed devices and/or were found safe for dental use."
• "OsteoGraf/N-300 and the marketed device are biocompatible."
• "OsteoGraf/N-300 conforms to applicable industry standards."
• "We believe that the prior use of the components of OsteoGraf/N-300 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/N-300 for the indicated uses."
• The FDA letter confirms "the device is substantially equivalent...to legally marketed predicate devices."

The "performance data provided" mentioned in the summary is not detailed in the provided text. It is highly probable that this "performance data" refers to standard materials testing, biocompatibility studies, and potentially historical clinical use of the predicate devices or components, rather than a clinical study with outcome-based acceptance criteria for a diagnostic/AI device.

Therefore, I cannot populate the requested table and answer the study-related questions for OsteoGraf/N-300 based on the information given. The questions you've asked are typically relevant for diagnostic devices, software as a medical device (SaMD), or AI/ML-enabled devices where performance metrics like sensitivity, specificity, or reader agreement are crucial. This document describes a material, not such a device.

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The intended use of OsteoGraf/N-300 is for:

• Treatment of infrabony periodontal defects. .
• Augmentation of bony defects of the alveolar ridge. ●
• Filling of extraction sites.
• Sinus elevation grafting ●

OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite. the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

The provided 510(k) summary for OsteoGraf/N-300 does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document is a premarket notification for a medical device submitted to the FDA. It primarily focuses on:

• Device identification: Submitter, device name, classification, and predicate device.
• Device description: Composition, size, and nature of OsteoGraf/N-300.
• Intended Use: Specific dental and oral surgery applications.
• Comparison to predicate device: Stating that OsteoGraf/N-300 is 100% anorganic hydroxylapatite, its chemical composition, and conformance to ASTM standards.
• FDA determination: A letter from the FDA stating that the device is substantially equivalent to a previously marketed device, allowing it to be marketed.

This type of submission, especially for a device from 1998, often relies on a demonstration of substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria. The equivalence argument is made based on material composition and intended use.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.

Here's a breakdown of what cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present; no test set or study data described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present; no ground truth or expert panel described for a study.
4. Adjudication method: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a bone-grafting material, 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.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present; no training set described.
9. How the ground truth for the training set was established: Not present.

The 510(k) summary provided is not a clinical study report and thus does not contain the detailed performance data, patient cohort information, or expert evaluation methods that would be required to answer these questions.

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The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

This document, K960348, is a 510(k) summary for a medical device (OsteoGraf/N-300 Hydroxylapatite) from 1996. It describes the device's characteristics, intended use, and comparison to a predicate device.

Crucially, this document is a pre-market notification (510(k) summary) from 1996 describing the device and its conformity to a standard. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods in the context of an AI/ML device as requested in the prompt.

Therefore, I cannot provide the requested information because the provided text does not contain any information regarding the evaluation of an AI-powered device. The device described, OsteoGraf/N-300 Hydroxylapatite, is a physical implant, not a software or AI-based diagnostic tool.

Therefore, all fields in your requested table will be marked as "Not Applicable" or "Information Not Provided in Document".

Here's a breakdown of why each section cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document only states the device conforms to the requirements of ASTM standard #F1581. It does not provide specific acceptance criteria or performance metrics in a table format for diagnostic accuracy, sensitivity, specificity, etc., which would be relevant for an AI device.
2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI device being tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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