(63 days)
The Titanium Turbine is intended for the following applications:
Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).
The Titanium Turbine is an air-driven dental handpiece used by qualified dental professionals. The Titanium Turbine is connected to a dental unit via a coupling and uses supplied compressed air to rotate a dental bar attached to its tip at a high speed (380.000-450.000 min-') to enable dental treatment.
Titanium Turbine is mainly made of titanium and can be reused by reprocessing. This device is equipped with a Clean Head System that reduces suck-buck into the head and exhaust line, thereby reducing cross-contamination of the air lines. Titanium Turbine is also equipped with a quick stop system that reduces the time required to stop rotation, thereby improving oral cavity safety, and reducing suck-buck.
The provided text describes the 510(k) premarket notification for a dental handpiece called "Titanium Turbine." It details the device's characteristics, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.
However, the information requested regarding acceptance criteria and a study proving the device meets the acceptance criteria (specifically related to AI/algorithm performance and human reader studies) is not present in the provided document. This document pertains to a Class I dental handpiece, which is a mechanical device, not an AI or algorithm-driven medical device. Therefore, the concepts of sensitivity, specificity, MRMC studies, human-in-the-loop performance, and ground truth establishment for AI models are not applicable to the information given.
The document focuses on demonstrating substantial equivalence to predicate dental handpieces based on:
- Mechanical and operational characteristics: Head size, weight, head angle, rotation speed, torque, noise level, chuck design, bur type, power, device features (Clean Head System, Quick Stop System).
- Material properties: Coating (DURAGRIP vs. Sand blasting finish/Plasmatec coating), direct/indirect patient contacting materials (Titanium vs. Stainless Steel).
- Sterilization and lubrication: Methods and compatible products.
- Performance testing against established standards: ISO 14457:2017 ("Dentistry Handpieces and motors") and ISO 17665-1:2006 ("Sterilization of health care products - Moist heat").
- Biocompatibility testing: According to ISO 10993-1:2018.
Therefore, I cannot populate the requested table and study details as they are outside the scope of this FDA submission for a mechanical dental device.
Summary regarding the absence of requested information:
- No AI/Algorithm Component: The device, "Titanium Turbine," is a mechanical dental handpiece. It does not involve any artificial intelligence, machine learning algorithms, or image analysis components.
- Acceptance Criteria: The "acceptance criteria" for this device are its compliance with recognized performance standards (ISO 14457, ISO 17665-1) and biocompatibility standards (ISO 10993-1), and demonstrating substantial equivalence to predicate devices based on its physical and functional characteristics. These are not performance metrics like sensitivity/specificity for AI.
- Study Proving Acceptance: The "study" proving acceptance is the series of non-clinical performance and biocompatibility tests conducted according to the listed ISO standards. No clinical study was required for this 510(k).
- Irrelevant Metrics: All the specific points requested (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set ground truth establishment) are relevant to the validation of AI/ML-based medical devices, not mechanical devices like a dental handpiece.
§ 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.