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The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The SI-Cure Sacroiliac Joint Fusion System consists of titanium bone screws of Ø7 mm, Ø9.5 mm, and Ø11 mm diameter and various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw head for load distribution. The screws are made from titanium alloy Ti-6A1-4V ELI that conforms to the ASTM F136 standard.

The provided text is a 510(k) premarket notification for the SI-Cure Sacroiliac Joint Fusion System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than on a clinical study to prove the device meets specific performance criteria through empirical patient data or diagnostic accuracy.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment from a clinical or diagnostic performance study cannot be extracted from this document, as such a study was not performed or referenced for this submission.

The document explicitly states:

"Bench testing was not required in this submission because the system name change, the updates to the indications for use statement, and the additional implant sizes, which do not introduce a new worst case, do not affect the safety and effectiveness of the device to require performance testing."

This indicates that the submission relies on the existing performance data and substantial equivalence of the predicate devices.

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