(92 days)
ImprEssix, Colorchange Alginate is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
ImprEssix, Colorchange Alginate is a dental impression material based on alginate.
The provided text is an FDA 510(k) clearance letter for the ImprEssix, Colorchange Alginate Impression Materials. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/machine learning device.
The questions posed (e.g., about multi-reader multi-case studies, standalone algorithm performance, training set size, etc.) are typical for the evaluation of AI or machine learning-based medical devices, which this product demonstrably is not. The ImprEssix material is a conventional dental impression material.
Therefore, I cannot answer the questions based on the provided text. To answer these questions, a document detailing the clinical validation or performance study of an AI/machine learning device would be required.
§ 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).