(98 days)
The STV PRO 2 is:
- a camera which delivers color images of the oral cavity,
- a communication tool which allows the patient and dentist to view the patient's oral cavity
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the STV PRO 2 dental operative unit and accessories. It confirms the device's substantial equivalence to a legally marketed predicate device.
The document discusses the regulatory aspects of the device, its classification, and requirements for marketing. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the manufacturer's 510(k) submission, but they are not present in the FDA's response letter provided.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding the study.
§ 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.