(359 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software Verification/Validation (EN 62304) | Device passed based on predetermined Pass/Fail criteria. |
| Temperature Test (ISO 14457, IEC 80601-2-60) | Device passed based on predetermined Pass/Fail criteria. |
| Eccentricity Test (ISO 14457) | Device passed based on predetermined Pass/Fail criteria. |
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.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.