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TRAUS SUS10, Piezo Surgery and Implant Engine Unit, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation (for ultrasonic surgery), and implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation (for dental implant surgery).

TRAUS SUS10, Piezo Surgery and Implant Engine Unit, combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device. TRAUS SUS10 includes a control box (main unit), foot controller and dental handpieces. The dental handpieces of TRAUS SUS10 are supplied with two types: Piezo handpiece and Dental implant motor handpiece incorporating an implant motor and an angle handpiece. When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.

The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification for a medical device called "TRAUS SUS10 Piezo Surgery and Implant Engine Unit," which is a dental surgery device.

The document discusses:

• The device's intended use and technological characteristics.
• Comparison to predicate devices to establish substantial equivalence.
• Non-clinical test summaries covering electrical safety, EMC, software validation, biocompatibility, sterilization validation, and mechanical performance testing.
• A explicit statement that "No clinical studies were considered necessary and performed."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as the provided text does not describe such a study or and the device is a piece of surgical equipment, not an AI or software-only device.

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For use in a wide range of dental procedures including; endodontic surgeries, such as drilling into the tooth canal, and general dentistry, such as removing carious material from the dentin.

The Ki-20 is designed to use in dental surgery. It consists of an E-type motor (DC 28V Operation Motor), handpieces, a control box, a foot switch and other accessories. It is designed that the speed and direction of the handpiece can be controlled by the control box and the foot switch. The irrigation tube and the pump are used to supply the cooling water for the successful surgery.

The provided set of documents is a 510(k) summary for the SAEYANG MICROTECH CO., LTD. Ki-20 dental handpiece. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness is not available within these documents.

However, based on the provided text, I can extract information about the types of tests performed and the general conclusion.

Here's a breakdown of the available information and why other requested details are missing:

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

The document does not provide a table of explicit acceptance criteria with numerical targets and corresponding device performance results. Instead, it lists various international standards that the device was tested against. The "reported device performance" is summarized as compliance with 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)

• Sample Size: The document does not specify the sample sizes used for any of the non-clinical bench tests. The nature of these tests (e.g., electrical safety, mechanical coupling) often involves testing a limited number of units to ensure compliance with specifications inherent in the standards.
• Data Provenance: The manufacturing company, Saeyang Microtech Co., Ltd., is located in the Republic of Korea. It can be inferred that the testing data originated from tests conducted in relation to this manufacturing location, likely by the manufacturer itself or a certified testing facility they employed. The tests are non-clinical bench tests, meaning they are not performed on patients and are effectively "prospective" in the sense that they are conducted to evaluate the device before widespread marketing.

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. The device is a dental handpiece, and the tests performed are primarily engineering and safety compliance tests against established international standards. There is no concept of "ground truth" established by human experts in the context of these non-clinical, objective performance tests. For example, validating coupling dimensions or electrical safety does not rely on expert consensus or interpretation of clinical data.

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

This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving subjective interpretations (e.g., imaging diagnostics) where multiple readers are involved and their disagreements need to be resolved to establish a robust ground truth. For the non-clinical, objective nature of the tests listed (e.g., checking if dimensions meet ISO standards), such an adjudication method is irrelevant.

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. The Ki-20 is a dental handpiece, a physical medical device. It does not incorporate Artificial Intelligence (AI) and is not a diagnostic device that would involve human readers interpreting data. Therefore, an MRMC study or an assessment of AI assistance is irrelevant to this device.

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

This is not applicable and not provided. Similar to point 5, the Ki-20 is a mechanical/electrical dental handpiece, not an algorithm or software-only device. There is no "standalone algorithm" performance to evaluate.

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

This is not applicable in the traditional sense. For the non-clinical bench tests, the "ground truth" implicitly comes from the specifications and requirements defined within the international standards (e.g., ISO, IEC) listed in the document. The device's performance is compared against these objective, predefined technical criteria rather than against clinical outcomes or expert interpretations.

8. The sample size for the training set

This is not applicable and not provided. The Ki-20 is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This is not applicable and not provided for the same reasons as point 8.

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