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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.

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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 this document does not contain the information you are looking for. This document is a letter from the FDA to Millennium Dental International, Incorporated regarding their 510(k) premarket notification for a POLY Siloxane Impression Material. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The document does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

Ask a specific question about this device