(10 days)
Westar Series Delivery Units are intended to be used by Dentists, Hygienists, and Dental Assistants, to supply power and utilities to, and serve as a base for, dental instruments and tools for traditional and normal patient treatment procedures in the dental operatory.
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I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for Westar Series Dental Units. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the letter does not contain any information regarding:
- Specific acceptance criteria.
- Details of a study proving device performance against acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
This document is a regulatory approval, not a scientific study report.
§ 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.