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AOC Bone Wax is intended for use in the control of bleeding from bone surfaces.

AOC Bone Wax is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by additional handling and manipulation, if so desired. AOC Bone Wax is provided sterile by irradiation and must not be resterilized.

Used for over 100 years, bone waxes stop bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. The wax, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

This 510(k) submission for AOC Bone Wax does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone performance (algorithm only) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

Key points from the document relevant to its purpose:

• Device Name: AOC Bone Wax, Ostene™, Osteotene™, Ceretene™
• Intended Use/Indications for Use: Control of bleeding from bone surfaces.
• Substantial Equivalence: The submission asserts that the modified AOC Bone Wax has the "same intended use fundamental scientific technology as the legally marketed AOC Bone Wax (K041363)." This is the core of a 510(k) submission – to show the new device is as safe and effective as an existing one, not necessarily to prove new performance metrics against predefined acceptance criteria through clinical trials.
• Predicate Device: Ceremed, Inc. AOC Bone Wax K041363.

This type of submission often relies on a comparison of technical characteristics, material properties, and intended use to an already approved device, rather than new extensive performance studies.

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