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cold-polymerizing paste-paste system for the preparation of temporary crowns, bridges, inlays and onlays

cold-polymerizing paste-paste system

The provided document is a 510(k) clearance letter from the FDA for a dental device called "Structur 2 SC," a temporary crown and bridge resin. This document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device.

It does NOT contain the detailed information required to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the device was cleared because it was shown to be as safe and effective as another device already on the market, not necessarily through a new, comprehensive clinical study with specific acceptance criteria as would be described for an AI/software as a medical device (SaMD).

Therefore, I cannot provide the requested information based on the content of these pages. The document does not describe:

1. A table of acceptance criteria and reported device performance: This information would be found in the premarket notification submission itself, not the FDA clearance letter.
2. Sample sizes, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, or type of ground truth for a test set.
3. Sample size or ground truth establishment for a training set.

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