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Intended to be used in edentulous patients as an anchor to support a prosthesis.

The Nobelpharma MirusCone Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw done. The abutment has a lower profile (vertical height) for use when the dentist desires a lower profile abutment. The only modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting the larger and smaller discussion in of fixture previously cleared.

The provided text is a 510(k) summary for a premarket notification for a dental device, specifically an abutment for an endosseous implant. It does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for an AI/ML device.

This document describes a modification to an existing device (K944964), stating that the technological characteristics between the modified and earlier versions are "identical," with only minor dimensional changes. The basis for substantial equivalence is the predicate device itself, implying that no new performance testing to specific acceptance criteria was required beyond demonstrating that the dimensional changes did not alter the fundamental safety and effectiveness of the device as compared to its predicate.

Therefore, the requested information regarding acceptance criteria and a study to prove the device meets these criteria cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

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