(70 days)
The THUNDER TIGER Dental Air-Powered Handpiece is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
Dental Air-Powered Handpiece, models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N
This document is a 510(k) summary for a "Dental Air-Powered Handpiece". The information provided does not describe an AI/ML device or present a study that meets the acceptance criteria for such a device. Instead, it describes a traditional medical device (a dental handpiece) and the basis for its substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.
Here's why:
- No AI/ML Component: The document clearly identifies the device as a "Dental Air-Powered Handpiece." There is no mention of artificial intelligence, machine learning, software algorithms for diagnosis or analysis, or any other component that would classify it as an AI/ML device.
- Substantial Equivalence, Not Performance Study: The entire premise of the 510(k) summary is to demonstrate "substantial equivalence" to a predicate device (TIGER 100 series). This is a regulatory pathway for traditional devices, not typically for novel AI/ML performance validation studies.
- Performance Data Basis: The document states, "The claim of substantial equivalence is based on Performance Data: comparisons of formulations and intended uses of the THUNDER TIGER Dental Air-Powered Handpiece and its claimed predicate." This usually refers to engineering specifications, material comparisons, and basic function tests to ensure it operates similarly to the predicate, not clinical accuracy or diagnostic performance as would be relevant for an AI/ML device.
To directly answer your request based on the provided text, but acknowledging the device is not an AI/ML device:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (THUNDER TIGER Dental Air-Powered Handpiece Model: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202) | The device is deemed "substantially equivalent" for its intended uses: removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations, and polishing teeth. |
| Compliance with general controls provisions of the Federal Food, Drug, and Cosmetic Act | This is expected through annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. (No specific performance metrics are provided in the summary.) |
| Intended Use as specified | The device meets the indications for use. |
2. Sample size for the test set and data provenance:
- Not applicable for an AI/ML device. This document describes a mechanical dental handpiece. There is no "test set" in the sense of a dataset for evaluating an algorithm's performance. The "performance data" mentioned likely refers to engineering tests and comparisons to the predicate device's specifications.
3. Number of experts and qualifications for ground truth:
- Not applicable. Ground truth generation by experts is relevant for diagnostic or analytical AI/ML systems. This is a mechanical device.
4. Adjudication method:
- Not applicable. Adjudication is for resolving discrepancies in expert labeling or diagnoses for AI/ML training/test sets.
5. Multi reader multi case (MRMC) comparative effectiveness study:
- No, an MRMC study was not done. This type of study is for evaluating human performance alongside or with AI assistance in diagnostic tasks.
6. Standalone (algorithm only without human-in-the-loop performance) study:
- No, a standalone study was not done. This is for evaluating AI algorithm performance without human intervention.
7. Type of ground truth used:
- Not applicable. For a mechanical device, "ground truth" relates to its physical performance meeting specifications, not expert consensus on medical images or patient outcomes.
8. Sample size for the training set:
- Not applicable. No AI/ML model for training.
9. How the ground truth for the training set was established:
- Not applicable. No AI/ML model for training.
In summary, this document is solely for a traditional medical device (dental handpiece) and its regulatory clearance via substantial equivalence, not for an AI/ML device performance study.
§ 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.