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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.

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