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The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

The Southern Implants PEEK abutments are endosseous dental implant abutments. The PEEK abutments are available in a variety of preformed and customized forms. The PEEK abutments are available as temporary abutments.

Temporary abutments are used as an aid in manufacturing a temporary prosthesis for prosthetic rehabilitation. They are used for direct connection to an endosseous implant. Temporary abutments are available in a 2 mm collar direct to implant.

These abutments are made from white PEEK (ASTM F2026).

The PEEK abutments are premanufactured and are available in a variety of connections, engaging and nonengaging, to suit the implant systems manufactured by Southern Implants.

Titanium retaining screws are also available to use with the PEEK abutments.

I am sorry, but the provided text is a 510(k) summary for a medical device (Southern Implants PEEK Abutments) and does not contain information about acceptance criteria and a study proving a device meets those criteria, especially for AI/ML-based devices.

The document explicitly states: "No clinical studies were conducted." and focuses on demonstrating substantial equivalence to a predicate device based on material, manufacturing, intended use, and non-clinical testing (sterilization, packaging, biocompatibility).

Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML device evaluation.

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