(88 days)
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.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide 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 models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).