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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.

• Arch Screw will be implanted in patient's bone then autograft will be inserted.
• Locking Screw can be used with washer or can be used on its own
• Self-tapping flute centers screw for easy insertion

This document is a 510(k) summary for the PathLoc SI Joint Fusion System, a Class II medical device. It's important to understand that a 510(k) submission primarily demonstrates "substantial equivalence" to existing legally marketed devices, rather than proving novel effectiveness or safety through extensive clinical trials.

The provided text focuses on the device's design, materials, and substantial equivalence to predicate devices, but does not contain information regarding studies that prove the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity, which would typically be found for AI/ML-driven devices or diagnostics.

Therefore, I cannot provide a response filling the requested sections as the document describes a traditional mechanical medical device, not one with performance characteristics that would be evaluated with the type of study design you're asking about (e.g., AI/ML performance, diagnostic accuracy etc.).

The document explicitly states:

• "A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. And the results of the risk assessment were confirmed, and that there were no problems with safety and effectiveness. None of the additional components is the worst case of the PathLoc SI Joint Fusion System and the additional components to be added through this submission do not require additional mechanical testing."
• "Therefore, we substitute mechanical test data of PathLoc SI Joint Fusion System for additional components with the predicate device data (K153656/K181600)."

This indicates that the "performance testing" was primarily a risk assessment and Finite Element (FE) analysis, comparing the new components to previously cleared predicate devices based on mechanical properties and safety, not a clinical study evaluating diagnostic or therapeutic accuracy against a ground truth.

To directly answer your prompt, the information about acceptance criteria and study proving device performance as you've outlined (e.g., sample size, expert ground truth, MRMC study, standalone performance, training set details) is not present in this 510(k) summary because it's not relevant for this type of device submission. This is a mechanical implant, not an AI or diagnostic device that would require such performance evaluations.

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