(237 days)
Tiger 500 Series High Speed Handpieces and Attachments are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
The Tiger 500 series High Speed Handpieces and Attachments are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices are supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single-use bag. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. According to IS07785-1:1997, Dental Handpiece-- Part 1: High-speed air turbine handpieces; and IS013485:2003, Medical Device Quality Management System to complete the device design steps.
The provided text is a 510(k) summary for the Thunder Tiger 500 Series High Speed Handpieces and Attachments. This document primarily focuses on establishing "substantial equivalence" to existing predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics (like sensitivity, specificity, accuracy, etc.) that would typically be found in an AI/software as a medical device (SaMD) submission.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or extractable from this type of regulatory document for a traditional medical device.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available or relevant to this type of submission:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" is demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and adherence to relevant standards. Performance is verified against mechanical and safety standards rather than clinical metrics.
| Acceptance Criteria (from ISO 7785-1 for dental handpieces) | Reported Device Performance (based on "Substantial Equivalence Table") | Comments |
|---|---|---|
| Functional Verification | "The functions of Tiger 500 series High Speed Handpieces and Attachments were verified according to ISO7785-1." | This indicates that the device met the functional requirements specified by the ISO standard. |
| Safety Data | "The performance and safety of the Tiger 500 series High Speed Handpieces and Attachments are based upon conformity with applicable aspects of ISO 7785-1. Bench testing results demonstrate substantially equivalence." | Compliance with safety aspects of ISO 7785-1 and other standards (ISO 13485) ensures the device is safe. |
| Substantial Equivalence to Predicate Devices | "Technological Characteristics" table (see below) demonstrates similarity/identity across various aspects. | This is the primary "performance" metric for a 510(k) submission, confirming it's as safe and effective as existing devices. |
Substantial Equivalence Table (from the document):
| TECHNOLOGICAL CHARACTERISTIC | COMPARISON TO PREDICATE |
|---|---|
| Intended use | Identical |
| Indications for use | Identical |
| Target population | Identical |
| Anatomical sites | Identical |
| Energy used and/or delivered | Similar |
| Human factors | Similar |
| Design | Similar |
| Performance | Similar |
| Standards met | Identical |
| Materials | Similar |
| Biocompatibility | Identical |
| Compatibility with environment and other devices | Identical |
| Sterility | Identical |
| Mechanical safety | Identical |
| Chemical Safety | Identical |
| Thermal safety | Identical |
| Radiation safety | Identical |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. This is a traditional medical device (dental handpiece), not a software/AI device that undergoes testing with a "test set" of data samples. The evaluation is based on bench testing of the physical device and comparison to standards and predicate devices.
- Data provenance: Not applicable in the context of data samples. The device itself is manufactured in Taiwan, ROC (Thunder Tiger Corp., Taichung).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "test set" or "ground truth" established by experts in the context of clinical data for this type of device. Regulatory bodies (like the FDA) and standards organizations (like ISO) define the requirements, and the manufacturer performs testing to demonstrate compliance.
4. Adjudication method for the test set
- Not applicable. No "test set" (of data) or adjudication process regarding expert opinions 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
- Not applicable. This device is a physical dental handpiece, not an AI or diagnostic imaging device. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" in this context is adherence to established international standards (ISO 7785-1:1997 for dental handpieces; ISO 13485:2003 for Quality Management Systems) and demonstrating substantial equivalence to legally marketed predicate devices. The "truth" is that the device meets these engineering specifications and performs comparably to existing, approved devices.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model that requires a training set of data.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI/software 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.