(146 days)
The Chiropro L system is intended for use in dental surgery, endodontics, and implantology. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants.
The Chiropro L system consists of a software-based drive unit that controls the speed of a dental micromotor. The Chiropro L system offers three different functional modes with operating parameters specific to a particular application (Implantology, Endodontics, and Dental Surgery). The Chiropro L system is equipped with an integrated peristaltic pump for use with external irrigation tubing allowing irrigation of the working area. The device is operated via the command buttons on the tabletop console or through a foot control. For implantology purposes, the Chiropro L system is intended to be used with a contra-angle handpiece with a 20:1 gearing ratio and a rotational speed between 5 rpm to 2000 rpm (designed to operate burs according to ISO1797-1, type 2). Two versions of the handpiece are available, with and without optical fibers conducting the light emitted by the motor to the surgical field.
The provided text is a 510(k) summary for the Bien-Air Dental SA Chiropro L system. This document is related to a medical device that controls dental handpieces, and it describes the device's technical characteristics and how it compares to predicate devices to demonstrate substantial equivalence for regulatory approval. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of diagnostic accuracy, which is typically found in AI/ML device submissions.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence to existing devices, electrical safety, and electromagnetic compatibility testing, rather than performance criteria that would typically be associated with diagnostic or AI-driven medical devices.
The text does not include information about:
- A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy or similar metrics).
- Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are generally relevant for evaluating the performance of diagnostic or AI-based devices, which this submission is not.
§ 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.