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For use in selected fully edentulous and partially edentulous arches

The additional fixture provided for by this 510(k) is added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. The implant is a root-form uncoated screw. It is cylindrical in shape. The coronal portion has a minute thread - microthread - and the apical part a magnified thread - Macrothread. It is made from commercially pure titanium. It has a defined surface texture achieved through titanium oxide grit blasting. The component is intended for use in selected fully edentulous and partially edentulous arches.

This 510(k) summary (K991053) describes an additional component, the MicroMacro fixture, for the Astra Tech Implants - Dental System. It is a premarket notification for a medical device and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML algorithm.

The document pertains to the regulatory clearance of a physical dental implant component, made of commercially pure titanium, with a specific design (microthread and macrothread). The FDA's review determined substantial equivalence to legally marketed predicate devices, allowing its market entry.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or human reader effectiveness with AI. These concepts are relevant to the evaluation of AI/ML-driven medical devices, not to a physical dental implant as described in this 510(k) summary.

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