(61 days)
The TWIN POWER TURBINE handpiece is for use by authorized persons in the practice of dentistry.
TWIN POWER TURBINE is a dental handpiece. This device receives energy resources in handpiece such as air for high speed air turbine, cooling water for cutting and light source for illumination, through the tubes connected to a dental unit. The cooling water is fed part of cutting treatment through pouring holes.
The provided document is a 510(k) summary for a dental handpiece, focusing on establishing substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, and detailed study design (sample size, ground truth, expert qualifications, etc.) is not present in the document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility | Similar |
| Standards met | Similar |
| Electrical safety | Similar |
| Thermal safety | Not applicable |
| Radiation safety | Not applicable |
Missing Information: The document does not provide specific quantitative or qualitative acceptance criteria for these categories (e.g., "Must meet ISO X for sterility" or "Performance must achieve Y RPM"). Instead, it broadly states "Similar" or "Identical" in comparison to the predicate device. Therefore, no specific 'device performance' metrics are reported, beyond the general claim of similarity/identity.
2. Sample size used for the test set and the data provenance
Missing Information: The document does not describe any specific test set size or data provenance (e.g., country of origin, retrospective/prospective) for a study of the device's performance. The submission relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: No information is provided regarding experts or ground truth establishment for a test set, as no specific performance study is detailed.
4. Adjudication method for the test set
Missing Information: No adjudication method is mentioned, as no specific test set or performance study is described.
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
Missing Information: This document describes a dental handpiece, which is a physical tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with AI assistance is not applicable and was not performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: As a physical dental handpiece, this question is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Missing Information: No ground truth information is provided, as no specific performance study is detailed. The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established performance of the predicate device.
8. The sample size for the training set
Missing Information: No training set is applicable or mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Missing Information: As no training set is applicable, no ground truth establishment method is provided.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):
The "study" presented in this 510(k) summary is a comparison to a legally marketed predicate device (Synea-HS High-Speed Handpiece from A-Dec, Incorporated, K992011).
- Methodology: The manufacturer performed a comparative analysis of the "TECHNOLOGICAL CHARACTERISTICS" of the TWIN POWER TURBINE against the predicate device. This comparison covered aspects like indication for use, target population, design, materials, performance, sterility, biocompatibility, safety features (mechanical, chemical, electrical), anatomical sites, human factors, energy usage, compatibility, and standards met.
- Proof of Meeting Acceptance Criteria: The conclusion drawn from this comparison is that the TWIN POWER TURBINE is "substantially equivalent" to the predicate device. The document states: "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison as below." The "acceptance criteria" here implicitly align with the performance and safety characteristics of the predicate device. By demonstrating that the new device is "Identical" or "Similar" across all listed technological characteristics, the submission asserts that it meets the implied "acceptance criteria" of being as safe and effective as its legally marketed equivalent.
In essence, for a 510(k) submission of this nature, the "study" is the demonstration of substantial equivalence, and the "acceptance criteria" are met if the FDA agrees that the new device does not raise new questions of safety or effectiveness compared to the predicate 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.