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EXPAZEN is a paste containing aluminum chloride which is intended to be used for temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

EXPAZEN is a paste containing aluminum chloride.

The provided text is related to an FDA 510(k) clearance for a dental device called EXPAZEN. This document is a regulatory clearance letter, not a study report. It does not contain information about acceptance criteria for device performance or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning its safety and effectiveness are comparable to devices already on the market. However, it does not describe the specific performance studies that might have been conducted to demonstrate this equivalence, nor does it detail any acceptance criteria met by the device.

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