(51 days)
Osteomed Corporation intends to market the OsteoPower System and Accessories for drilling or cutting bone or teeth, and for driving screws and/or pins and wires into bone, in conjunction with dental, craniofacial, craniotomies, orthognathic, spinal, mandibular, hand, foot, wrist, and extremity reconstruction surgical procedures.
OsteoPower System and Accessories
I am sorry, but the provided text from the FDA 510(k) notification for the "OsteoPower System and Accessories" does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document is a letter from the FDA to Osteomed Corporation, dated June 27, 1997, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and provides contact information for further guidance. The "Indications for Use" are also described.
Therefore, I cannot provide the requested information based on the provided input.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.