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The Eminent Spine Sl Screw System is intended for sacroiliac joint fusion for conditions including degenerative sacroillitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

The Eminent Spine Sacroiliac (SI) Screw System is intended for sacroiliac joint fixation for conditions including degenerative sacroiliac joint disruption. The Eminent Spine SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136 using traditional machining methods, as well as 3D-printed titanium alloy Ti-6AI-4V ELI per ASTM F3001. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy. The cannulated screws have open and porous graft windows for the Ø8.5, Ø10.0, Ø11.5, and Ø13.0mm options to allow bone growth through the implant. Optional locking crowns/locking fangs are included for all of the available screw diameters to aid in conforming to patient anatomy.

The provided text is a 510(k) summary for the "Eminent Spine SI Screw System." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain any information regarding acceptance criteria, reported device performance data, study design, sample sizes, ground truth establishment, or expert qualifications as would be typical for a clinical or performance study evaluating an AI/ML powered medical device.

The "Non-Clinical Testing" section mentions mechanical testing per ASTM F3574, but it only states that the results "support that the strength of the subject SI Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." It does not provide specific acceptance criteria or performance metrics in a way that would allow filling out the requested table.

Therefore, I cannot provide the detailed information requested in the prompt because the necessary details are not present in the provided text. The document is for a traditional medical device (a screw system), not an AI/ML powered device, and thus the type of performance evaluation details requested (e.g., effect size of human readers with AI, standalone algorithm performance) are not applicable or included.

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