Search Results

Dental High-speed Turbine Handpiece (WJ-114, WJ-122, WJ-124, WJ-134, WJ-132, WJ-144, WJ-142, WJ -154, WJ -162, WJ -162) is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low-speed Turbine Handpiece (WJ-414, WJ-424, WJ-422) is intended for removing carious material, excess filling material, cavity and crown preparations and restorations and restorations, root canal preparations and polishing teeth.

The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an instrument for drilling, grinding, repairing. It composed of handpiece and a connector, including models WJ-114, WJ-112, WJ-124, WJ-134, WJ-132, WJ-144, WJ -142, WJ -154, WJ -152, WJ -164, WJ -162.
The Dental Low-speed Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an 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 WJ-414, WJ-412, WJ-424, WJ-422

This document is a 510(k) summary for a dental handpiece, not a study report. It aims to demonstrate substantial equivalence to predicate devices, not to prove the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in this type of regulatory submission.

However, based on the provided text, I can extract information about performance tests conducted to support substantial equivalence, which implicitly serve as acceptance criteria for functionality and safety.

Here's a breakdown of the available information and why other requested details are not present:

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

The document doesn't present explicit "acceptance criteria" in a numerical or pass/fail table format, as one might find in a clinical study report for a diagnostic device. Instead, it relies on performance tests aligning with recognized standards to demonstrate substantial equivalence to predicate devices. The "Elements of Comparison" table (pages 6-7) serves a similar purpose by comparing the subject device's characteristics against predicate devices, implying that if the subject device meets or is comparable to the predicate's performance/specifications, it is acceptable.

Below is an attempt to create a table based on the provided "Test Summary" and "Elements of Comparison", reinterpreting compliance with standards and equivalence to predicate devices as meeting "acceptance criteria".

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. Performance tests typically involve laboratory testing of a small number of device samples rather than human subject test sets. The document states "Performance testing was provided," but doesn't detail the number of units tested for each standard. Data provenance is also not mentioned, but given the manufacturer's location (Foshan, China), it's highly likely tests were conducted in China or by certified labs on behalf of the manufacturer. These are not "test sets" in the clinical study sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable and not provided. This document describes premarket notification for a Class I dental handpiece, which typically involves demonstrating substantial equivalence through engineering, performance, and biocompatibility testing against recognized standards and predicate devices, not clinical trials requiring expert-established ground truth. Expert review, if any, would be for the regulatory submission itself by the FDA, not for establishing ground truth for device performance data (which comes from lab tests).

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

This is not applicable and not provided. Adjudication methods are relevant for clinical studies where multiple experts evaluate ambiguous outcomes. This document details laboratory and performance testing, which does not involve this kind of adjudication.

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

This is not applicable and not provided. MRMC studies are used for diagnostic devices, particularly those involving image interpretation by human readers, often with AI assistance. This device is a dental handpiece (a surgical/treatment tool), not a diagnostic or AI-assisted interpretation system.

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

This is not applicable and not provided. This refers to AI algorithm performance. The device is a mechanical dental instrument.

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

This is not applicable in the context of this device and report. For the performance tests conducted, the "ground truth" would be the specification limits defined by the relevant ISO and IEC standards (e.g., a specific bur retention force, a defined RPM range). For biocompatibility, it's compliance with established biological safety requirements.

8. The sample size for the training set

This is not applicable and not provided. "Training set" refers to data used to train machine learning algorithms. This device is a mechanical tool.

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

This is not applicable and not provided. See point 8.

Ask a specific question about this device

The Dental High-speed Handpiece Halley Series is intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The Dental High-speed Handpiece Halley Series is a hand-held instrument which propelled by a small air-powered turbine (or rotor), capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with the turbine. The main materials of the dental handpiece and accessories are stainless steel. Rotation speed range is around 330,000-390,000 rpm. Our couplings are in compliance with the Type 1, Type 3 of the recognized standard ISO 9168 Hose connectors for air driven dental handpieces, and vary with the most famous brands in the world.

This document is a 510(k) premarket notification for a Class I medical device, specifically a Dental High-speed Handpiece Halley Series. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance against acceptance criteria in the way an AI/ML device would. Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

However, I can extract the information relevant to device performance and acceptance criteria as presented in a substantial equivalence context.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a dental handpiece), "acceptance criteria" are generally derived from recognized medical device standards and comparisons to predicate devices. The performance data presented focuses on technical specifications that demonstrate equivalence.

Ask a specific question about this device

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

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.

Ask a specific question about this device