(300 days)
Dental Low-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including low speed air motor, straight handpiece and geared angle handpiece, for the model LN and L. The device description of the Dental Low-speed Handpiece is as following:
The gear ratios of handpieces have various gear ratios (for different geared angle handpiece) (1:1 (constant), 20:1 (speed reduction) and 1:5 (speed increase));
The handpieces have maximum Forward rotation speed 19000 rpm and maximum Reverse rotation speed of 18000 rpm.
The air motors are capable of running up to a speed of 22000 rpm, but different pressure of air supply; refer to section 2.3 for details.
The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only.
This document is a 510(k) summary for a "Dental Low-speed Turbine Handpiece." It's a submission to the FDA seeking clearance for a new medical device by demonstrating its substantial equivalence to a legally marketed predicate device.
The provided text does not contain any information about a study based on artificial intelligence (AI), machine learning, or software performance evaluation for diagnostic purposes. The device in question is a physical dental instrument. Therefore, it's impossible to extract the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment in the context of AI/ML.
The "Test Summary" section (page 5 of the document) refers to:
- Performance test according to ISO 14457 standard: This standard relates to the mechanical and physical performance of dental handpieces.
- Biocompatibility test according to ISO 10993-1: This standard relates to the biological safety of medical devices in contact with the body.
- Reprocessing and Sterilization test according to ISO 17665:2006 and ISO 11134:2003 standards: These standards relate to the sterilization and resterilization of medical devices.
- Reprocessing validation according to FDA guidance document Dental Handpieces - Premarket Notification [510(k)] Submissions: This relates to the validation of cleaning and sterilization protocols for dental handpieces.
These are all standard engineering and biocompatibility tests for a physical medical device, not a software or AI/ML diagnostic.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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.