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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.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which are primarily based on equivalence to predicate devices and adherence to recognized standards) is a non-clinical bench testing summary.

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

• Not Applicable (N/A). This is a hardware device without a "test set" in the context of AI/ML performance evaluation. The "testing" involved bench tests against engineering specifications and international standards.
• The manufacturer is MicroP Technology (Taiwan), Inc., located in Taiwan. The testing would have been conducted by or for them.

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)

• N/A. This device does not generate diagnostic interpretations or rely on expert-annotated "ground truth" data for its function. Performance is evaluated against objective engineering specifications and standards.

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

• N/A. Adjudication methods are relevant for subjective interpretations of data, typically in AI/ML performance studies. This is a physical device where performance is measured objectively.

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

• N/A. 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

• N/A. This is a mechanical device, not an algorithm.

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

• N/A. The "ground truth" for this device's performance is objective measurements against engineering specifications and compliance with international standards (e.g., ISO 14457, ISO 1797-1, ISO 9168).

8. The sample size for the training set

• N/A. This device does not involve a "training set" as it is not an AI/ML algorithm.

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

• N/A. No training set exists for this device.

Summary of the Study:

The study performed to establish substantial equivalence for the Dental High-speed Handpiece Halley Series was a non-clinical bench testing summary. This testing verified that the device adheres to applicable technical standards and internal specifications. The specific standards considered include:

• ISO 14457 (Dentistry — Handpieces and motors)
• ISO 1797-1 (Dentistry — Shanks for rotary instruments)
• ISO 5349-1 (Mechanical vibration)
• ISO 9168 (Dentistry — Hose connectors for air driven dental handpieces)
• IEC 62366 (Usability engineering)
• ISO 10993 series (Biological evaluation of medical devices: Part 1, Part 5, Part 10)
• ISO 17664 (Sterilization of medical devices)
• ISO 17665-1 (Sterilization of health care products — Moist heat)
• IEC 60601-1 (Medical electrical equipment - basic safety and essential performance)
• IEC 60601-1-2 (Medical electrical equipment - Electromagnetic compatibility)
• IEC 62471 (Photobiological safety)

The report concludes that based on the comparison of technological characteristics, demonstrated through bench testing and intended use, the Dental High-speed Handpiece Halley Series is substantially equivalent to its predicate devices (KALTENBACH & VOIGT GMBH MASTERtorque LUX 8900 L and MODERN KOREA CO., LTD. MDK handpieces). Clinical testing was explicitly stated as not performed.

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