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The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

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I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) premarket notification acceptance letter for a dental implant system. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the following information that would allow me to answer your questions:

• Acceptance criteria and reported device performance: There are no specific performance metrics, benchmarks, or test results mentioned for the Ace HA Screw Dental Implant System.
• Details of any studies: There is no description of any clinical or non-clinical studies conducted for this device, including information on sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
• Information regarding AI or algorithm performance: The device described is a physical dental implant system, not a software device or an AI-powered system. Therefore, questions related to standalone algorithm performance, AI assistance, or MRMC studies are not applicable.

The document is purely an administrative confirmation of market clearance based on substantial equivalence, not a detailed report of device testing or performance.

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