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Intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide the study and for production of catestication study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Novel Print Cyan Alginates

This appears to be a 510(k) clearance letter from the FDA for a dental impression material called "Novel Print Cyan Alginates." This document does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging algorithms.

The document is a regulatory approval for a physical dental product, confirming its substantial equivalence to a predicate device. It discusses the regulatory classification, general controls, and labeling requirements for the product.

Therefore, I cannot extract any of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies because these concepts are not applicable to the content of this specific document.

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Nic Tone Acrylic Resins are used in the fabrication, repair or rebasing of complete or partial removable dentures, the fabrication of veneer crowns, the fabrication of orthodontic devices, and the fabrication of temporary crowns and bridges.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification letter from the FDA regarding "Nic Tone Acrylic Resins," confirming its substantial equivalence to legally marketed predicate devices. It discusses regulatory classifications, general controls, and responsibilities of the manufacturer but does not delve into specific performance studies or acceptance criteria for the device itself.

Ask a specific question about this device