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OSTENE® is indicated for use as a water-soluble implant material for use in the control of bleeding from bone surfaces and as a water-soluble space occupying material as an adjunct during the natural healing process.

Ostene® is a water-soluble odorless, opaque wax-like material consisting of a sterile mixture of alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Ostene® is provided sterile by irradiation and must not be resterilized.

This is a 510(k) premarket notification for a medical device (Ostene Implant Material), not a study report for an AI/ML powered device. As such, it does not contain the information required to answer your prompt regarding acceptance criteria and a study proving a device meets those criteria, particularly within the context of AI/ML performance.

The document discusses substantial equivalence to predicate devices based on intended use, fundamental scientific technology, and biocompatibility. It does not mention any performance metrics, studies with test sets, ground truth establishment, or human reader effectiveness with or without AI assistance.

Therefore, I cannot populate the table or provide the requested details because this K062280 document does not contain information about studies related to AI/ML device performance.

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