(188 days)
The Primado is an electrically powered surgical system for delicate bone dissection in the ear, nose and throat areas. A wide range of attachments includes a In the car, dood and chrous, straight/angle/malleable drills, and microsaws.
The Primado is an electrically powered surgical system.
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
The document is an FDA 510(k) clearance letter for the "Primado Surgical Drill," indicating that it has been found substantially equivalent to a legally marketed predicate device. It specifies the intended use of the device and regulatory information but does not contain any performance study details or acceptance criteria for demonstrating that performance.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.