(257 days)
Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument (>>ENDO file
The cordless ENDO-handpiece EB-300 (EB-300 S) consists of the cordless drive EB-3 H (EB-3 SH) and the special contra-angle attachment EB-16 (EB-16 S), intended for mechanical rotating root canal preparation. The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. By means of the different buttons on this drive, the user controls the various functions, such as on / off, speed, torque and auto-reverse / auto-forward mode. The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964. The handpiece's application is intended in dentistry.
The provided 510(k) summary for the W&H Cordless ENDO-Handpieces "ENTRAN" and "S5 ENDO Motor" states that clinical data were not needed and that bench testing results demonstrate substantial equivalence. This indicates that the device's acceptance criteria were based on functional performance and comparison to a predicate device, rather than patient-level outcomes.
Here's a breakdown based on your requested information, with specific notes where information is explicitly not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument. | Technological Characteristics: Revised and improved version of the predicate device, retaining main technical characteristics. Advantages found in usability (less weight, smaller size, better balanced, ergonomically designed). |
| Technological Equivalence: Similar technological characteristics to the predicate device. | The new products' advantages can be found above all in its usability: less weight and smaller size, better balanced, ergonomically designed. |
| Performance Parameter Equivalence: Similar performance parameters to the predicate device. | The intended use, technological characteristics, performance parameter and material are very similar to the predicate device. |
| Material Equivalence: Similar materials to the predicate device. | The intended use, technological characteristics, performance parameter and material are very similar to the predicate device. |
| Substantial Equivalence to Predicate Device: "Tri Auto ZX", J. Morita USA Inc., K970339. | The new devices are substantially equivalent to the predicate devices. Bench testing results demonstrate substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document only mentions "Bench testing results."
- Data provenance: Not specified. As it's bench testing, it would be laboratory-generated data rather than patient data from a specific country.
- Retrospective or prospective: Not applicable for bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for most bench tests relies on engineering specifications, physical measurements, and adherence to standards rather than expert clinical consensus.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. Bench tests typically involve direct measurement against specifications or comparison to a predicate device's performance under controlled conditions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC study: No, an MRMC study was not done. The document explicitly states: "Clinical data were not needed for these new products." This type of study would involve human readers and clinical cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Yes, implicitly. The "Bench testing results" without clinical data indicate that the device's technical performance was evaluated independently, without requiring human-in-the-loop performance evaluation in a clinical setting for regulatory purposes. The device itself is an "algorithm" only in the sense of its mechanical and electrical function, not in the AI/software sense often associated with "standalone" studies in medical imaging.
7. The type of ground truth used
- Type of ground truth: The ground truth for this type of device (dental handpiece) would be based on engineering specifications, performance metrics (e.g., speed, torque, battery life, mechanical integrity), and direct comparison against the predicate device's documented performance. There's no indication of pathology, expert consensus, or outcomes data being used as ground truth for this 510(k).
8. The sample size for the training set
- Sample size for training set: Not applicable. This device is a mechanical/electrical handpiece, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Any development data used by the manufacturer would be internal design and testing data.
9. How the ground truth for the training set was established
- How ground truth was established for training set: Not applicable, as there is no "training set" for this type of device. The ground truth for design and development would be established through engineering principles, material science, and performance targets set by W&H Dentalwerk Buermoos GmbH.
§ 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.