(67 days)
The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.
The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures. The control unit is equipped with a roller pump to deliver saline solution or sterile water as irrigant to the handpiece. The electric micromotor and its cord are autoclavable. The irrigation tube set used between the irrigation nozzle at the handpiece and the saline solution bottle via roller pump is supplied as an accessory item in the control unit package. It is ETO sterilized for 10 sterility, pyrogen-free. The control unit has risk of explosion if used in the presence of flammable anesthetics.
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Surgic IV Dental Implant Unit," stating that the device is substantially equivalent to legally marketed predicate devices.
The letter discusses:
- The device name and regulation details.
- The FDA's substantial equivalence determination.
- General controls provisions of the act.
- Requirements for registration, labeling, good manufacturing practice, and quality systems.
- Contact information for various FDA offices.
- Indications for Use for the device.
- Remarks about the device's features (roller pump, micromotor, irrigation tube set, risk of explosion with flammable anesthetics).
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any tests.
- Details about experts used for ground truth or adjudication methods.
- Information about MRMC comparative effectiveness studies.
- Results of standalone algorithm performance studies.
- The type of ground truth used in any study.
- The sample size for any training set or how ground truth for a training set was established.
Therefore, I cannot provide the requested information based on the given input.
§ 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.