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Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers

The product is composed of powder and liquid portions.

This document describes the 510(k) summary for the Compolute® Aplicap® dental cement, focusing on its substantial equivalence to predicate devices rather than pre-market clinical study data with specific acceptance criteria. Therefore, several requested categories are not directly applicable or explicitly detailed in the provided text.

Based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not describe a clinical test set with a specific sample size. The primary evidence presented is a comparison against predicate devices and adherence to industry standards. This is not a study in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" here is regulatory compliance and comparison to established predicate devices and standards, not a diagnostic outcome.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication.

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. The device is a dental cement, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a dental cement, not an algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is:

• Regulatory Substantial Equivalence: Demonstrated by comparing the device's composition and intended use to previously cleared predicate devices according to FDA guidelines.
• Industry Standards: Compliance with DIN, ISO, and ADA standards for dental cements.
• Safety Data: Provision of fluoride release data.

8. The sample size for the training set

Not applicable. This is not a machine learning device; therefore, there is no training set in that context. The "training" in the regulatory sense comes from the existing knowledge base and data behind the predicate devices and industry standards.

9. How the ground truth for the training set was established

Not applicable in the context of a machine learning training set. The "ground truth" for demonstrating substantial equivalence is established through:

• Prior FDA clearances: The predicate devices (Sono®-Cem, Pertac® II, Ketac-Fil Aplicap Plus, Protemp® Garant, Panavia 21, Variolink II, Scotchbond Resin Cement, Nexus dental cements) have already undergone regulatory review and have an established safety and effectiveness profile.
• Industry consensus standards: DIN, ISO, and ADA standards represent established best practices and scientifically sound criteria for dental materials, developed and maintained by expert bodies.
• Scientific literature/data: Underlying data supporting the composition and performance characteristics of dental cements, including fluoride release.

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