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The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The Dental Unit(model: Mare) is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry. Dental Unit (model: Mare) consists of dental chair, arm dentist unit, assistant's unit, dental light, cuspidor, water unit, and multi-function foot control. It mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Dental Unit (model: Mare) which are attached by means of industry standard ISO connections. The ancillary dental devices include pneumatic handpieces, 3-way syringe, strong suction and weak suction vacuum instruments. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are 510k clarence in the K142206. Based on Safety does not manufacture pneumatic handpieces, the pneumatic handpieces shall be purchased by the enduser. The recommended pneumatic handpieces are 510(k) clearance K170229 and K170236, which are held by GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. None of the Dental Unit (model: Mare), parts or accessories are provided sterile.

This document is a 510(k) premarket notification for a dental unit, indicating it's primarily a regulatory submission for device clearance. It does not contain the detailed acceptance criteria and study results typically found in reports specifically designed to demonstrate device performance against such criteria for AI/ML devices.

The document discusses the substantial equivalence of the "Dental Unit: model Mare" to a predicate device (K142206). The "acceptance criteria" here refers to the compliance with recognized consensus standards for medical devices and the demonstration of safety and effectiveness through non-clinical testing.

Here's an attempt to extract the requested information based on the provided text, with the understanding that it's a regulatory submission and not a performance study report:

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

The "acceptance criteria" for a medical device in a 510(k) submission are typically compliance with recognized standards. The "reported device performance" is the statement that the device meets these standards.

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

This document describes non-clinical testing against standards for a physical medical device (dental unit), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of a "test set" in the context of data used for algorithm evaluation (as implied by the question) is not applicable here. The testing involves physical testing of the device itself to conform to engineering and safety standards. No information on data provenance (country, retrospective/prospective) is provided as it's not relevant for this type of submission.

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)

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set. The "ground truth" is established by the specifications of the recognized consensus standards.

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

Not applicable. This is not an AI/ML device requiring adjudication of 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

No. This document explicitly states in Section 8: "There was no clinical testing performed." This is for a dental unit, 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 is a physical dental unit, not an algorithm.

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

For this device, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international and national consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 7494-1 for dental unit general requirements). Compliance with these standards is the ground truth for performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML model.

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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.

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