(259 days)
Disposable high speed air turbine handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
The disposable high-speed air turbine handpiece is an air-driven dental handpiece for the use by a trained professional in the field of general dentistry. The device is an ergonomically shaped air-powered handpiece that is disposable. The device features a 4-pin (drive air, exhaust air, spray air and spray water holes) connector for air and water input and return. A water/air mist cools the head and bur. Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine.
The disposable high-speed air turbine dental handpiece is an instrument widely applied in oral therapy. It is composed of interrelated parts, working as a complete set. The disposable high-speed air turbine dental handpiece is an air-driven handpiece which supplied with water and air through the pipe and the coupling of a dental treatment unit. The device contains air and water pipes inside which supply air for driving the turbine assembly rotating and cooling water for work site as well as supply air and water for creating spray. The air-driven turbine assembly provides rotation to the bur for removing carious material, excess filling material, cavity, and is used for crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
The handpiece is supplied non-sterile and must be cleaned and sterilized before use.
The provided document is an FDA 510(k) Substantial Equivalence Determination for a medical device (Disposable High Speed Air Turbine Handpiece). It details the device's characteristics, intended use, and comparison to a predicate device, along with the non-clinical testing performed to establish substantial equivalence.
However, the document does not describe a study involving an AI/machine learning device. Specifically, it is for a physical dental handpiece, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to compliance with engineering standards and performance benchmarks for a mechanical device, not an AI algorithm.
Therefore, I cannot provide the detailed information requested in your prompt (such as sample size for test/training sets, data provenance, number of experts, MRMC studies, standalone performance, etc.) because these concepts are applicable to AI/ML device studies, not the type of device and study described in this 510(k) summary.
The document confirms that this is a traditional 510(k) submission for a physical dental handpiece and explicitly states: "No clinical studies were performed."
If you were expecting information related to an AI/ML device, this document is not the correct source. It focuses on the substantial equivalence of a physical dental instrument based on its design, materials, and performance against established engineering standards (ISO 14457, ISO 9168, ISO 10993-1, etc.).
§ 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.