(89 days)
The intraoral camera system, Optum, of Camsight, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.
Not Found
The provided document is a 510(k) clearance letter for the Optum Intraoral Camera System, indicating that the device has been found substantially equivalent to legally marketed predicate devices. This type of regulatory document typically does not contain detailed information about acceptance criteria, specific performance studies, or technical validation data as would be found in a clinical study report or a more comprehensive technical submission.
The letter confirms the device's indications for use and its classification but does not delve into the depth of information requested in your prompt regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.
Therefore,Based on the provided text, the requested information cannot be extracted. The document is a regulatory clearance letter and does not include details on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodology.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.