(108 days)
Intended to be used for making accurate dental impressions. The resulting impressions are used to make plaster models of the teeth.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a dental impression material named "Virtual 380". This document focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria typically found in a clinical study report or a more comprehensive premarket submission.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the approval is based on demonstrating equivalence, not necessarily on a new clinical study with specific acceptance criteria as you've outlined.
To answer your questions, one would need to review the actual 510(k) submission document (K060891) itself, which is not provided here.
§ 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).