(77 days)
The Power drive System is a small battery-powered device, light-weight, low speed motor handpiece, for use in light general dental works where low speed and low torque is required.
The Power drive System is a small battery-powered device, light-weight, low speed motor handpiece, for use in light general dental works where low speed and low torque is required.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for a medical device.
The document is a 510(k) summary for a device called "Power drive," which is a dental handpiece. It primarily focuses on the administrative aspects of the 510(k) submission, such as:
- Submitter details
- Date of summary
- Reason for submission
- Trade name and classification
- FDA's response letter
- Indications for Use statement
The FDA letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. The "Indications for Use" describes the device's intended purpose as "a small battery-powered device, light-weight, low speed roto-motor handpiece, for use in light general dental works where low speed and low torque is required."
Without information directly related to performance metrics, a study design, or validation results, it is impossible to complete the requested table or answer the specific questions about acceptance criteria and study details.
§ 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.