(126 days)
The TRI AUTO ZX device is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used to measure the length of the canal, and it can be used as a low speed motorized handpiece.
The TRI AUTO ZX device is a cordless endodontic treatment motorized handpiece with root canal measurement capability.
I apologize, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted on the "TRI AUTO ZX" device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device.
The letter mentions the device's indications for use:
- Cordless endodontic treatment motorized handpiece with root canal measurement capability.
- Enlarge canals while monitoring the position of the file tip inside the canal.
- Measure the length of the canal.
- Used as a low speed motorized handpiece.
However, there is no data or details regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.