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Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

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This document is a 510(k) clearance letter from the FDA for a dental impression material. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The letter acknowledges that the device (Template and CounterFit) is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. However, it does not detail any performance studies, test results, ground truth establishment, or sample sizes related to the device's technical specifications.

Therefore, I cannot provide the requested information based on the provided text.

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Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Multiple (POLY SILOXANE IMPRESSION MATERIAL)

I am sorry, but the provided text is a 510(k) clearance letter for a dental impression material and does not contain the information requested about acceptance criteria and study details for a device. The document is a regulatory approval, not a scientific study report.

Therefore, I cannot extract:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness studies.
6. Information on standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device