(161 days)
The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
The device is an assortment of various sizes and configurations of stainless steel bone screws.
The provided text is related to a 510(k) submission for an "Orthopedic Screw System." It describes the device, its intended use, and substantial equivalence to predicate devices, along with the FDA's decision. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment that would be typically found in a clinical study report or a summary of safety and effectiveness data.
Therefore, I cannot extract the requested information from the provided input. The document is primarily a regulatory clearance letter, not a performance study report.
If you have a document that details the performance study, please provide it, and I will do my best to answer your questions.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.