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Ossiform is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including: periodontal defects, ridge augmentation, extraction sites, cranio-facial augmentation, sinus lifts and cystic defects

Ossiform is a synthetic bioactive glass that is intended for use in the repair of oral/maxillofacial and dental intraosseous defects. The bioactive glass granules are supplied sterile in a polyolefin vial within a sealed pouch.

The provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria.

The document is a 510(k) summary and FDA clearance letter for a device called "Ossiform." It describes the device, its intended use, and its substantial equivalence to predicate devices already on the market.

Specifically, it mentions:

• "The performance of Ossiform was evaluated using a variety of test methods. The results of these tests demonstrate that Ossiform is substantially equivalent to a predicate device." However, it does not detail these test methods, specify any acceptance criteria, or present performance data from a study.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth.

The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices, rather than a detailed presentation of performance study results against predefined acceptance criteria.

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