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The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System includes the SILO TFX Cone, SILO TFX Screw, and the SILO TFX Locking Screw and associated manual surgical instruments. The SILO TFX Cone is comprised of titanium alloy and incorporates a hollow conical shaped barrel with two openings for bone screws for additional anchoring. During the procedure, the implant is inserted in line with the SI Joint via a posterior surgical approach, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery.

The provided text is a 510(k) summary for a medical device (SILO TFX MIS Sacroiliac Joint Fixation System) seeking FDA clearance. It describes the device, its indications for use, and how it compares to predicate devices. However, this document does not contain the detailed acceptance criteria for a study or the results of a study designed to prove the device met those criteria.

The "Performance Testing Summary" section only briefly mentions that the device underwent some mechanical tests (static and dynamic axial compression, static and dynamic compressive shear, and static and dynamic vertical shear testing) and states that "The subject devices met all acceptance criteria for all tests." It also mentions a cadaver study that "demonstrated that the SILO TFX System provides comparable stability of the joint to the predicate."

Crucially, the document does not provide:

• A table of acceptance criteria and reported device performance (with specific numerical values).
• Sample sizes for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance details (as this device is hardware, not an AI algorithm).
• Type of ground truth used (beyond the implied "mechanical stability" in the cadaver study and compliance with ASTM standards in other tests).
• Sample size for the training set (not applicable for this type of device, which is not an AI/ML algorithm).
• How ground truth for the training set was established (again, not applicable).

Thus, I cannot answer the request with the provided information. The document confirms that testing was done and the device met criteria, but it does not detail those criteria or the specific results.

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