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Intended for temporary root canal filling during endodontic therapy.

CIMOFLUOR

The provided text is a 510(k) clearance letter from the FDA for a device called CIMOFLUOR, which is a root canal filling resin. This document grants market clearance based on substantial equivalence to a predicate device, rather than providing details of a clinical study or acceptance criteria.

Therefore, the document does not contain the information required to answer the questions about acceptance criteria and study details.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided. The document refers to a "premarket notification" but does not detail the testing performed or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 provided. The device is a root canal filling resin, 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 physical product, not an algorithm.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable (not an AI device).
9. How the ground truth for the training set was established: Not applicable (not an AI device).

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