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Dental High-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

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.

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This document is a 510(k) clearance letter for a Class I dental handpiece, and does not contain information about acceptance criteria or a study proving that an AI/ML device meets acceptance criteria. The information provided in the prompt relates to general regulatory requirements for medical devices, not the specific performance evaluation of an AI-powered diagnostic or treatment device.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves a device meets them based on the provided text, as the text is a regulatory clearance for a physical dental tool, not an AI/ML device.

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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.

Ask a specific question about this device