(105 days)
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a D.C. brushless micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.
The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a D.C. brushless micromotor that is activated by means of a footswitch.
I'm sorry, but without further context, the provided text does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance. The document appears to be a 510(k) clearance letter for a dental motor, indicating that the device has been found substantially equivalent to a predicate device. However, it does not include details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for any test set.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
- Sample size or ground truth establishment for a training set.
Therefore, I cannot fulfill your request based on the provided input.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.