(28 days)
COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reprocluce the structure of a patient's teeth and gums.
COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material.
I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) premarket notification letter from the FDA to Zhermack S.p.A. for their device named "COLORISE RIGID". This letter primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
While it mentions the device is an "impression material" and "intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums," the document does not contain any information regarding:
- Specific acceptance criteria for the device's performance.
- Details of any study conducted to demonstrate the device meets acceptance criteria.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Whether MRMC or standalone performance studies were done.
- The type of ground truth used or how ground truth for training data was established.
This document is an administrative approval letter, not a scientific study report or a detailed technical specification.
§ 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).