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Hiossen Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The Hiossen Prosthetic system is intended for use as an aid in prosthetic restoration. It consists of Abutments, overdenture components and Abutment Screws. The Hiossen Prosthetic system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a dental prosthetic system, and it primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's what is missing from the document based on your request:

• A table of acceptance criteria and reported device performance: The document mentions safety, performance, and product validations but does not provide a table with specific criteria and results.
• Sample size and data provenance for a test set: This information is not present.
• Number and qualifications of experts for ground truth: This is not discussed.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "No clinical studies are submitted."
• Standalone algorithm performance study: This is not a software device, and no such study is described.
• Type of ground truth used: Not applicable given the nature of the device and the lack of clinical studies.
• Sample size and ground truth establishment for the training set: Not applicable and not mentioned, as this is a hardware device approval, not an AI/software device.

The document states: "Proposed devices in this submission are substantially equivalent to the predicate devices Therefore we didn't consider conducting additional test but biocompatibility test and retention test of O-Ring are conducted because material of O-Ring is changed." This indicates that the primary method of demonstrating safety and effectiveness was through comparison to existing cleared devices, with limited specific testing mentioned for material changes.

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