(84 days)
Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.
The provided document is a 510(k) premarket notification letter from the FDA for a "Dental Tray, Sterile, Disposable" manufactured by Trinity Laboratories, Incorporated.
This document does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) performance. The letter is solely an FDA notification of substantial equivalence for a medical device.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or the number/qualifications of experts for a test set.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set or how ground truth for a training set was established.
This document is a regulatory approval for a physical medical device (a sterile, disposable dental tray) and not a submission or report for an AI/software as a medical device.
§ 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.