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Quickset™ is a quick-setting temporary restorative material.

Quickset™ Liquid and Powder

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Quickset™ Liquid and Powder," which is a quick-setting temporary restorative material.

The letter states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to devices marketed prior to May 28, 1976. However, it does not provide details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for any test sets.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is a regulatory clearance and not a scientific study report.

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