Search Results

for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

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

The provided text describes a medical device called OsteoGraf/LD-300, a hydroxylapatite material intended for bone filling and augmentation. However, the document is a 510(k) summary from 1996 for premarket notification, which focuses on device description, intended use, and comparison to predicate devices to establish substantial equivalence.

Crucially, this document does not contain information about acceptance criteria for device performance in a clinical study, nor does it describe a study proving the device meets such criteria in terms of diagnostic or clinical efficacy.

Instead, the document focuses on:

• Material composition: "100% anorganic hydroxylapatite, Ca1o(PO4),OH2."
• Material properties: "X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/LD-300 to be 100% hydroxylapatite."
• Compliance with standards: "OsteoGraf/LD-300 conforms to the requirements of ASTM standard #F1185, 'Composition of Ceramic Hydroxylapatite for Surgical Implants.'"
• Physical form: "manufactured as rounded, irregular shaped synthetic hydroxylapatite particles, sized at 250-420 microns."

These are specifications and characterizations of the material itself, not performance metrics derived from a clinical efficacy study with acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and study details because the provided text does not contain them. The 510(k) summary is for a material device, not a diagnostic or AI device that would typically have acceptance criteria related to accuracy, sensitivity, or specificity in a performance study with a test set, ground truth, and expert adjudication.

Ask a specific question about this device