Search Results

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.

Ask a specific question about this device