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The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

The PRO M CLASS is an AC-powered device that includes a 'Motor Handpiece', 'Contra angle Handpiece', 'Charger unit' and 'AC/DC Adaptor' for grinding, cutting, polishing and screw driver work in dental oral use. The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this. The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.

This document is a 510(k) K213897 clearance letter for the Saeyang Microtech Co., Ltd. PRO M CLASS dental handpiece. It asserts substantial equivalence to a predicate device and reference devices but does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document focuses on regulatory compliance and comparison to previously cleared devices. Therefore, the requested information cannot be extracted from the provided text.

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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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This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.

The motor turned by the power converted into DC2.4V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.

The provided text describes Saeyang Microtech's ENDO a class device, a cordless endodontic handpiece. The 510(k) summary (K123582) details its intended use, substantial equivalence to predicate devices, and the non-clinical tests performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through compliance with established international standards and a comparison of technical specifications with predicate devices to establish substantial equivalence.

Based on the provided information, the acceptance criteria relate to compliance with regulatory standards and functional equivalence to predicate devices.

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

The document describes non-clinical bench tests performed to ensure compliance with relevant ISO and IEC standards. These tests typically do not involve "test sets" in the sense of patient data. Instead, they involve testing of physical devices or components against specified technical requirements and protocols.

• Sample Size: Not explicitly stated as a number of devices, but the testing would have been conducted on a representative sample of the ENDO a class device.
• Data Provenance: The tests were conducted internally by Saeyang Microtech in Korea, with results being "Complied" for each standard. Given the nature of bench testing for regulatory submission, this would be considered prospective testing for the purpose of demonstrating compliance.

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

This question is not applicable to this submission. The device is a direct drive, AC-powered handpiece for endodontic procedures, not an AI or diagnostic imaging device that requires expert-established ground truth from clinical data. The "ground truth" here is the adherence to engineering and safety standards.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy involving multiple human readers, which is not relevant for this device. The non-clinical tests involved verifying physical and functional specifications against established standards.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for a dental handpiece. The device is a mechanical tool, and the submission explicitly states: "No clinical testing was conducted."

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

This question is not applicable. The ENDO a class is a physical device, a dental handpiece, not an algorithm or AI system.

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

The "ground truth" in this context refers to compliance with established international standards (ISO, IEC) for medical devices, specifically dental handpieces, and the functional specifications of the device meeting pre-defined thresholds or being comparable to predicate devices. It is based on engineering and performance testing protocols.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI or machine learning device.

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

This question is not applicable. There is no "training set."

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

The motor turned by the power converted into DC24V by controller delivers its turning power to the bur through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.

The provided text describes a 510(k) summary for the Saeyang Microtech ENDO e class device, which is a dental handpiece and accessories. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) that a clinical study would typically assess. Instead, the "acceptance criteria" for this 510(k) revolve around compliance with established safety and performance standards for dental devices and demonstrating substantial equivalence to legally marketed predicate devices.

The "reported device performance" is essentially a description of the device's features and its compliance with relevant standards.

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

The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set in the sense of patient data. The "tests" were non-clinical bench tests and compliance with standards. The data provenance would be from manufacturing and engineering tests conducted by Saeyang Microtech in Korea.

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, as no clinical testing with patient data or expert-adjudicated ground truth was performed or required for this type of 510(k) submission.

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

Not applicable, as no test set requiring ground truth adjudication from experts was used.

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 (a physical tool), not an AI-powered diagnostic or assistive software. Therefore, an MRMC study or AI-related effectiveness metrics are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the non-clinical tests, the "ground truth" was derived from the specifications and requirements of the international and national standards (e.g., IEC 60601-1, ISO 3964) and the performance characteristics of the predicate devices for comparison. For example, for speed accuracy testing, the ground truth would be the expected or specified speed, and the device's measured speed would be compared against that.

8. The sample size for the training set

Not applicable, as this is a physical device and not an AI/ML model that requires a training set.

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

Not applicable.

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