(247 days)
Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.
The “PROXEO Twist Cordless Polishing System PL-40 H” is an electrical drive unit for cleaning and polishing tooth surfaces and fillings by use of Disposable Prophy Angles, so-called "DPAs". The system consists of - the cordless drive handpiece PL-40 H, - the wireless foot controller C-NW, - a handpiece holder, and - a charger inclusive adaptor. Its basic function is the conversion of electrical energy into a mechanical rotary motion. Power is supplied by a Li-ion battery, which is assembled in the drive handpiece and can be recharged by means of the provided charging cable. The battery is not changeable by the user. The device's application is intended in dentistry.
The provided document is a 510(k) Premarket Notification for a dental device, the "PROXEO Twist Cordless Polishing System PL-40 H." This document aims to demonstrate substantial equivalence to a legally marketed predicate device, not to prove the device meets specific performance acceptance criteria for an AI/ML medical device.
Therefore, the information required to answer your request (acceptance criteria, study details for AI/ML performance, sample sizes, expert qualifications, ground truth, etc.) is not present in the provided text. The document focuses on regulatory compliance for a traditional medical device, specifically dental handpieces, through comparison of technological characteristics and non-clinical testing for safety and electrical performance.
The document explicitly states:
- Clinical Testing: "Clinical performance testing was not conducted." (Page 6)
- The comparison is based on "similarities in intended use, principles of operation, functional design and structure." (Page 6)
In summary, the provided text does not contain the information requested about acceptance criteria and studies demonstrating performance for an AI/ML device.
§ 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.