(252 days)
This air-powered dental handpiece is intended for removal of carious material, cavities and crown preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.
The TRAUS Air Dental handpieces are air driven dental handpieces for the use by a trained dental professional. The devices are air-powered handpieces that are reusable and designed accordance with international standard. The devices can be sterilized by the prevacuum steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high-speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port.
Using in combination with dental unit chair, it is possible to use by installing the instrument at air handpiece according to purpose. It is possible to change the rotation speed by adjusting the flowing air.
The provided document is a 510(k) premarket notification for a dental handpiece (TRAUS Air Dental Handpiece) and does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.
The document discusses the substantial equivalence of the TRAUS Air Dental Handpiece to a predicate device (Maxima PRO 45L) based on technical characteristics and non-clinical performance data. It explicitly states: "No clinical performance testing was performed."
Therefore, I cannot provide the requested information, such as:
- Table of acceptance criteria and reported device performance: This document does not establish performance criteria in the way an AI/ML device study would (e.g., sensitivity, specificity, AUC). Instead, it compares the technical specifications and operational principles of the new device to a predicate device.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance: These are all concepts relevant to clinical or AI/ML performance studies, which were explicitly stated as "not performed."
- Type of ground truth: Not applicable as it's a mechanical device with no AI component requiring ground truth.
- Sample size for training set, how the ground truth for the training set was established: Not applicable as there is no training set for an AI/ML model.
The "Non-clinical Performance Data" section (page 6) details bench tests conducted to ensure conformity to ISO standards (ISO 14457, ISO 17665-1, ISO 9168) and demonstrate substantial equivalence. These are engineering and sterilization validation tests, not performance studies as typically understood for AI/ML devices.
In summary, the provided text describes a 510(k) submission for a conventional dental handpiece, and thus does not contain the information requested about acceptance criteria and a study for an AI/ML driven 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.