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Once finalized into a suitable design, the n!ce™ glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns.

Straumann® n!ce™ glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) glass ceramic material intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne teeth. The material is suitable for use in inlays, onlays, veneers, copings and monolithic crown restorations.

The provided text is a 510(k) summary for a dental device (Straumann n!ce Glass-Ceramic Blocks). It describes the device's characteristics and compares them to a predicate device to establish substantial equivalence. However, it does not contain information about an AI/ML-driven medical device, nor does it include a study proving device performance against acceptance criteria in the context of human-in-the-loop or standalone AI performance.

The document details performance testing for the physical properties of the ceramic blocks (e.g., flexural strength, chemical solubility, thermal expansion, biocompatibility) as required for dental materials, not for an AI algorithm's diagnostic or assistive capabilities.

Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI performance, sample sizes for AI test/training sets, expert qualifications or adjudication methods for AI ground truth, or MRMC studies from the provided text.

The text focuses on materials science and engineering performance of the dental blocks themselves, not on an artificial intelligence's performance.

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