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The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. This submission adds an additional screw option to the system.

This document is an FDA 510(k) clearance letter for a medical device called the "PathLoc SI Joint Fusion System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to AI or algorithm performance.

The content of the provided text focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory requirements and classifications.
• Description of the device and its intended use (sacroiliac joint fusion).
• Material composition.
• A brief mention of "performance testing" through engineering analysis, stating that added components do not introduce a "new worst case" and don't require additional mechanical testing. This refers to mechanical integrity and safety of the implant itself, not AI performance.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, as the provided text does not contain this information. The device in question is a physical implant (bone screws), not a software or AI-driven diagnostic or therapeutic device.

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