(98 days)
The SI Screw System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis.
The SI Screw System consists of bone screw in various lengths and graft hole configurations to accommodate variations in patient anatomy. The SI Screw System is manufactured from Titanium alloy in accordance with ASTM F136. All implants will be provided non-sterile and are intended for single use only.
I am sorry, but based on the provided text, there is no information about acceptance criteria, the study that proves a device meets acceptance criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for an AI/device for medical image analysis.
The document is a 510(k) premarket notification for a medical device called the "SI Screw System," which is a metallic bone fixation fastener (sacroiliac joint screw) used for sacroiliac joint fusion. The document focuses on showing substantial equivalence to a predicate device through mechanical testing (static and dynamic bending, torque-to-failure, axial pullout) of the physical screw system, not on the performance of a diagnostic or image analysis device.
Therefore, I cannot provide the requested information.
§ 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.