(391 days)
The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The proposed MedShape DynaFuse Fixation System is a sterile, single use orthopedic implant system consisting of a threaded bone fastener and washer. The DynaFuse Fixation System is designed to apply compression across a target fracture or fusion site and is intended to be used for fracture and osteotomy fixation, including joint arthrodesis. The devices provided sterile, intended for single use, and are comprised of titanium alloy and nickel-titanium.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any clinical study details such as sample size, data provenance, expert ground truth, or adjudication methods in the context of an AI/algorithm-enabled medical device.
The provided document is a 510(k) premarket notification for the DynaFuse Fixation System, which is a physical orthopedic implant system (a threaded bone fastener and washer). The tests mentioned (Static Torsion Test, Static Strain Test, Fatigue Strain Test, Bacterial endotoxin testing) are engineering and biocompatibility tests for physical medical devices and are not related to the performance of an AI or software algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets them for an AI/algorithm-based device from this document.
§ 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.