(213 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance (TRAUS ENDO) |
|---|---|
| Compliance with IEC 60601-1 (medical electrical safety) | Conforms |
| Compliance with IEC 60601-1-2 (electromagnetic compatibility) | Conforms |
| Compliance with ISO 14457 (dentistry-handpieces and motors) | Conforms |
| Compliance with ISO 17665-1 (sterilization of healthcare products-moist heat) | Conforms |
| Compliance with ISO 1797-1 (shanks for rotary instrument) | Conforms |
| Compliance with ISO 10993-1 (biological evaluation of medical devices) | Conforms |
| Technical Characteristics Substantially Equivalent to Predicates | Demonstrated through comparison table and bench testing |
| No new clinical risks compared to similar market devices | Evaluated based on literature research (non-clinical) |
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.
§ 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.