Search Results

• Core buildups. ■
• . Cementation of pins and posts when used with suitable dentin adhesive.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "Alpha-Core DC" device, primarily focused on confirming its substantial equivalence to a predicate device for specific indications of use (core buildups and cementation of pins and posts).

The letter does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about a study's sample size, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) studies, effect sizes, or standalone algorithm performance.
• Details on the sample size or ground truth establishment for a training set (which would be relevant for AI/ML devices, but this device is a dental material).

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device