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Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.

They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.

The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.

Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,

Gold Alloy and Polyacetal (POM): Direct Casting Abutment.

This document is a 510(k) premarket notification for a dental prosthetic device, not an AI software. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, and related ground truth establishment methods is not present in the provided text.

Specifically, the document focuses on demonstrating substantial equivalence of the Dentium Implantium® & SuperLine® Prosthetics to legally marketed predicate devices based on:

• Indications for Use: The devices are intended as an aid in prosthetic rehabilitation, matching the predicate devices.
• Design and Materials: Similarities in materials (Pure Titanium Grade 4, Co-Cr-Mo alloy, Gold Alloy, Polyacetal) and general shapes are emphasized. Minor differences in dimensions (total length, diameter, hex height) are noted but deemed not to affect application.
• Performance Bench Testing: Biocompatibility testing (ISO 10993-1) and mechanical performance testing (ISO Static compressive, ISO Fatigue, Corrosion Testing, Adaptation Accuracy) are reported.
• Non-clinical Testing: This includes "Reliability Calculation and Testing," "Fatigue Strength Testing," and "Static Load Failure Testing" in accordance with FDA guidance for dental implants/abutments.

The provided text does not contain:

• Any mention of acceptance criteria or performance metrics related to an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Details on a test set's sample size for an AI/ML model, its provenance, or how ground truth was established by experts.
• Information on Multi-Reader Multi-Case (MRMC) studies or human-in-the-loop performance with AI assistance.
• Details about training sets for an AI/ML model.

Therefore, I cannot provide the requested table or study details specific to AI/ML device performance. The information in the document pertains to the physical and material characteristics and safety/performance of a traditional medical device (dental prosthetics).

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