(88 days)
JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.
Jet Bite and Jet Blue Bite are two component impression materials based on vinylpolysiloxanes used for the registration of occlusion between the maxilla and mandible. Jet Bite and Jet Blue Bite are mixed during application and applied directly to the teeth, after which the mandible is moved into centric occlusion making an impression.
The provided document (FDA 510(k) Clearance Letter - K250969) is for dental impression materials (Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast). Unfortunately, this document does not describe a study involving an AI/software device that requires intricate ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.
The "Acceptance Criteria and Study" section in the document refers to performance testing for the physical properties of the impression material based on ISO 4823 standards, not an AI model's performance.
Therefore, I cannot fulfill your request for an AI device's acceptance criteria and study details based on the provided text. The document focuses on the substantial equivalence of a physical dental impression material to a predicate device, as opposed to the validation of a software algorithm.
If you have a document describing the validation of an AI/software device, I would be happy to analyze it against your request.
§ 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).