(32 days)
The Odyssey ITM Dental Water unit with CAT filter is indicated for use as an in-line water disinfecting system to reduce microorganisms and particulate matter in the dental waterline.
Odyssey ITM Dental Water unit
I am sorry, but based on the provided document, I cannot answer your request. The document describes a 510(k) premarket notification for a dental water unit and focuses on regulatory approval rather than a study about the device's performance or acceptance criteria.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes, data provenance, or details of a test set.
- The number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Details about a standalone algorithm performance study.
- The type of ground truth used.
- The sample size for a training set.
- How ground truth for a training set was established.
§ 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.