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The intended use of OsteoGraf/N-700 is for:

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

OsteoGraf/N-700 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 420-1000 microns.

This 510(k) summary describes a medical device called OsteoGraf/N-700, which is a hydroxylapatite material intended for various dental and orthopedic bone-filling applications. The summary primarily focuses on characterizing the device and establishing its substantial equivalence to a predicate device (Bio-Oss).

The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory submission (510(k) summary) focused on device description, intended use, and comparison to a predicate device to demonstrate substantial equivalence, not on specific performance studies with acceptance criteria as typically seen for diagnostic or AI-driven devices.

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