(156 days)
The TEK USA Airdriven LED handpiece with Integrated E-Generator is indicated for use by a trained dental professional authorized in the practice of general dentistry. These dental handpiece devices are available in both high and low speed and are designed for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations/restorations, polishing teeth and other procedures that are considered within the space of dental prophylaxis.
TEK USA Airdriven LED Handpiece with Integrated E- generator
The provided document describes a 510(k) premarket notification for the "TEK USA Airdriven LED Handpiece with Integrated E-generator." This submission demonstrates substantial equivalence to a predicate device, the W&H Alegra Air-Driven Highspeed Handpiece (K082716), rather than proving the device meets specific acceptance criteria through a standalone study. The primary method of demonstrating equivalence is through comparison of technological characteristics and compliance with recognized international standards.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in the typical sense of a performance study (e.g., sensitivity, specificity, accuracy thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and compliance with relevant standards.
| Acceptance Criteria (Demonstrated by Comparison/Compliance) | Reported Device Performance (Comparison Result/Compliance) |
|---|---|
| Indication for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar (based on use of FDA cleared autoclave) |
| Biocompatibility | Similar (demonstrated by compliance with ISO 10993) |
| Mechanical safety | Similar (implied by standards compliance) |
| Chemical Safety | Similar (implied by standards compliance) |
| Anatomical sites | Similar |
| Human factors | Similar |
| Energy used and/or delivered | Similar |
| Compatibility with environment/other devices | Similar |
| Where used | Identical |
| Standards met (e.g., ISO, EN) | Compliant with multiple ISO and EN standards |
| Electrical safety | Similar (implied by standards compliance) |
| Thermal safety | Not applicable (for this type of device) |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical data is not needed for most dental handpieces cleared by the 510(k) process." Therefore, there was no test set with a sample size or data provenance to evaluate specific device performance in a clinical setting. The evaluation was based on engineering design, material characteristics, and compliance with industry standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical test set was used, there were no experts used to establish ground truth in the context of a performance study. The "ground truth" for the substantial equivalence claim relies on comparing characteristics to the established predicate device and confirming compliance with recognized standards, which are developed by expert bodies.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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
Not applicable. This device is a dental handpiece, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human readers are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical tool operated by a human, not an algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device (W&H Alegra Air-Driven Highspeed Handpiece, K082716) and compliance with international safety and performance standards (e.g., various ISO and EN standards listed on page 2). The assumption is that if the new device demonstrates similar technological characteristics and meets the same safety standards as a legally marketed predicate device, it is equally safe and effective.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.