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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.

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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.

The Dental High-speed Turbine Handpiece is the dental treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. 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 and efficiency can be improved. Cartidges have high precision when rotating, cartiridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).

The provided document describes a 510(k) premarket notification for a Class I medical device, the Dental High-speed Turbine Handpiece. The document details the device's substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding detailed acceptance criteria and a study to prove them is not applicable in this context.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide specific numerical acceptance criteria for performance in a clinical sense. Instead, it compares the subject device's specifications and performance to predicate devices and adherence to relevant standards.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable. This is not a clinical study assessing patient outcomes or device performance on a test set of data/patients. The "test set" here refers to the physical device being tested against engineering standards.
• Data Provenance: Not applicable in the context of clinical data. The performance claims are based on engineering tests and comparisons to predicate devices, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on diagnostic images) is not relevant for this type of device submission. The "ground truth" for this device is established through compliance with recognized standards and successful engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There is no clinical adjudication of results for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a dental handpiece, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: The "ground truth" for the device's safety and effectiveness is established through adherence to ISO standards (ISO 14457 for performance, ISO 10993-1 for biocompatibility, ISO 17665:2006 and ISO 11134:2003 for sterilization), and reprocessing validation according to FDA guidance. It is also based on demonstrating substantial equivalence to existing legally marketed devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

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