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The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant.

The ITI Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are titanium anqled copings for the ITI anterior implant.

The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping is adapted to the individual restoration.

This document describes a 510(k) premarket notification for a dental device, specifically a "Titanium coping for ITI anterior implant." The information provided in the document is for a traditional device submission and does not include any details on acceptance criteria or a study proving that a device meets such criteria.

The document states that the device is "substantially equivalent to previously cleared ITI copings," and its "intended use...is identical to the predicate copings." This suggests that the substantial equivalence was likely established through a comparison of material properties, design features, and intended use with the predicate devices, rather than through a performance study with specific acceptance criteria that would typically be associated with new or significantly modified medical devices, especially those involving AI or complex functionalities.

Therefore, your request for the following information cannot be fulfilled based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided. The submission appears to be based on design and material comparisons, not performance testing on a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment relevant to AI/performance studies is mentioned.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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