(45 days)
The Block Stop Wires device is intended for use in the osteosyntheses of epiphysial fractures with small osteoarticular fragments and for temporary support of dislocations of small articulations.
The Block Stop Wires device is an internal wire fixation device to be used on various types of articular fractures.
I apologize, but the provided text from the document "K964087" is a 510(k) summary for a medical device called "Block Stop Wires." It describes the classification, substantial equivalence, device description, intended use, and technological characteristics of the device.
However, the document does not contain any information regarding acceptance criteria, device performance study results, sample sizes, expert qualifications, ground truth, or adjudication methods. Therefore, I cannot generate the requested table or answer your specific questions based on the input provided.
To answer your questions, I would need a document that details the device's validation studies and performance evaluation.
§ 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.