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The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

The TRAUS ENDO is an AC-powered device that includes a power unit, charging station and contra-angle handpieces, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, which are used for grinding, cutting, and polishing work in dental oral use. It is used for endodontic surgery with 600-1,000 rpm.

The provided text is a 510(k) summary for a medical device called "TRAUS ENDO," which is a dental handpiece. The document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific performance acceptance criteria through clinical trials or algorithm performance evaluations.

Therefore, the information requested about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance, ground truth establishment, training set details), and specific performance metrics (like effect size or standard performance values) for proving the device meets acceptance criteria cannot be found in this document.

This type of 510(k) submission generally relies on demonstrating the new device is as safe and effective as a legally marketed predicate device, often through:

• Comparison of technological characteristics: Showing similarities in design, materials, and operating principles.
• Performance testing to standards: Demonstrating compliance with relevant electrical safety, biocompatibility, and sterilization standards (as listed in Section 12). These are typically engineering tests, not clinical studies involving human or animal subjects for performance evaluation.
• Verification/Validation: Ensuring the device design meets specified requirements and user needs.

Based on the provided text, I can extract the following information related to "performance data" (which in this context refers to engineering and quality assurance tests, not clinical performance):

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

The document states that "The following tests were conducted, and the device passed all of the tests based on predetermined Pass/Fail criteria." However, it does not explicitly list the specific quantitative acceptance criteria or the numerical results for these tests. It only lists the types of tests performed.

Note: The document also references assessments for Biocompatibility (ISO 10993) and Reprocessing Validation (cleaning, sterilization per ISO 17665-1) that were performed on previously cleared predicate devices with the same materials and processes.

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

• Sample Size: Not specified. The tests mentioned (Software, Temperature, Eccentricity) are typically performed on a limited number of manufactured units or prototypes to demonstrate compliance with standards, not on a "test set" in the context of a large-scale clinical performance study.
• Data Provenance: Not explicitly stated, but these are likely internal lab tests performed by the manufacturer (Saeshin Precision Co., Ltd.) to engineering standards. There is no mention of country of origin for any "data" beyond the manufacturing location. The study is not a retrospective or prospective clinical study.

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

This information is not applicable to the "performance data" presented in this 510(k) summary. The tests performed are engineering and quality assurance tests that do not involve human expert interpretation for ground truth establishment.

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

This information is not applicable as the "performance data" refers to technical-compliance testing, not human-read interpretation of data requiring 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. The device is a dental handpiece, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness study was conducted or reported in this document.

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

This is not applicable. The device is hardware (a dental handpiece) and its accompanying components. It is not an algorithm, and its performance is not measured in a standalone computational manner.

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

The concept of "ground truth" as typically applied to diagnostic AI models is not applicable here. The "ground truth" for the engineering performance tests (Temperature, Eccentricity) would be the specific quantitative limits defined by the ISO/IEC standards (e.g., maximum allowable temperature, maximum allowable eccentricity), and the "truth" of the software passing would be its adherence to specified functional requirements.

8. The sample size for the training set:

This is not applicable. The device is not an AI model requiring a training set.

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

This is not applicable. The device is not an AI model.

In summary, the provided document is a regulatory submission for a Class I medical device based on substantial equivalence, which primarily relies on demonstrating compliance with recognized standards and similarity to predicate devices rather than comprehensive clinical performance studies involving large datasets or AI components.

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The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-45EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).

The TRAUS ENDO is an AC-powered device that includes a power unit, charging station and contra-angle handpieces, ACL(B)-41EP, ACL(B)-42EP and ACL(B)-45EP, are grinding, cutting, and polishing work in dental oral use.

Based on the provided document, here's an analysis of the acceptance criteria and the study conducted for the TRAUS ENDO device:

1. Table of Acceptance Criteria & Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., specific sensitivity, specificity, accuracy targets). Instead, the study's acceptance was based on conformity to established medical device standards and demonstrating substantial equivalence to predicate devices through technical characteristics and bench testing.

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing for the TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-45EP.

• Sample Size for Test Set: The document states "TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-45EP samples were compliant." It does not specify the exact number of samples tested for each model or for each test. It implies that a sufficient number of samples were tested to demonstrate compliance.
• Data Provenance: The data is from bench testing conducted by Saeshin Precision Co., Ltd. (Republic of Korea), the manufacturer. It is prospective in the sense that these tests were performed specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study involved bench testing against engineering and safety standards, not a clinical study with a ground truth established by medical experts. The "ground truth" was the specifications and requirements of the referenced international standards.

4. Adjudication Method for the Test Set

This is not applicable in the context of this submission. Adjudication methods are typically used in clinical trials to resolve discrepancies among expert readers. Here, the "test set" involves physical device performance measurements evaluated against pre-defined standard requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The TRAUS ENDO is a dental handpiece, a mechanical device, and its performance evaluation does not involve human interpretation of output in the same way.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the TRAUS ENDO device. The device is a physical instrument, not an algorithm. Its performance is inherent to its design and manufacturing.

7. Type of Ground Truth Used

The "ground truth" used for this study was the requirements and specifications outlined in the referenced international standards (IEC 60601-1, IEC 60601-1-2, ISO 14457, ISO 17665-1, ISO 1797-1, ISO 10993-1). Device performance was measured and compared directly to these established standards.

8. Sample Size for the Training Set

This is not applicable. The TRAUS ENDO is a mechanical dental handpiece, not an AI or machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

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