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The Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement. This material can be used for final cementation of crowns, bridges, inlay, onlays, veneers, posts and pins, and cementation of orthodontic bands and appliances.

Prime-Dent® Dual Cure Composite Luting Cement is a light and chemical curing, filled composite, multi-purpose permanent cement.

I am sorry, but I cannot fulfill your request to describe acceptance criteria and associated studies for the "Prime-Dent® Dual Cure Composite Luting Cement" based on the provided text.

Here's why:

The provided document is a 510(k) substantial equivalence letter from the FDA. This letter indicates that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, that those differences do not raise different questions of safety or effectiveness.

This type of FDA letter generally does not contain the detailed acceptance criteria and study results you are asking for. It's a regulatory notification, not a scientific publication or a technical report of device performance studies.

Specifically, the document does not contain any of the following information requested in your prompt:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The letter states the "Indications for Use" for the device, which describes what the cement is intended for (final cementation of crowns, bridges, etc.), but it doesn't provide performance metrics or studies to prove these indications.

To get the information you are looking for, you would typically need to consult a pre-market approval (PMA) application, a scientific publication, or the manufacturer's technical documentation, which are not found in this 510(k) clearance letter.

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