(203 days)
The CHALLENGE-EVER is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental operative unit and accessories (CHALLENGE-EVER / HL-2060, HL-2060A). It primarily pertains to regulatory approval based on substantial equivalence to predicate devices. This type of document does not contain the detailed information required to answer questions about acceptance criteria, study designs, sample sizes, ground truth establishment, or human reader performance from a clinical trial.
Therefore, I cannot extract the requested information from this document. The letter only establishes that the device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." It does not describe performance acceptance criteria or the specific study that proves the device meets such criteria.
§ 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.