(83 days)
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that is a control and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light. It is intended as a control unit for the handpiece used in general dental applications for crown preparation, cavity preparation, finishing the crown, inlay filling, polishing, prophylaxis and endodontic treatment, with use of straight, right- and or the fining, ponsibiling, provithout internal coolant, of equal, step-up, or stepdown speed sheath. The maximum free speed of the electric micromotor is 40,000 rpm.
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that is a control and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light.
The provided text is a 510(k) clearance letter from the FDA for the "Elect-Mate E" device, an Electric Control Unit with Micromotor. It primarily addresses the device's substantial equivalence to a predicate device and its intended uses.
However, the document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested table or answer the specific questions related to the study design and results based on the given text.
The document only states that:
- The device is an "Electric Control Unit with Micromotor."
- Its regulation number is "872.4200" and regulatory class is "I."
- It is intended for general dental applications, including crown preparation, cavity preparation, finishing the crown, inlay/filling, polishing, prophylaxis, and endodontic treatment.
- It has a maximum free speed of the electric micromotor of 40,000 rpm.
- The electric micromotor and its cord are not autoclavable, requiring adequate covering for infection control.
To answer your questions, I would need a document detailing the actual performance studies conducted for the Elect-Mate E 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.