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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.

PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.
· 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

The provided document is a 510(k) premarket notification for a medical device called the "PathLoc-SI Joint Fusion System." It describes the device, its intended use, and compares it to a legally marketed predicate device.

Crucially, this document is for a mechanical medical device (bone fixation fastener), not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/SaMD performance metrics (like sensitivity, specificity, AUC, etc.) does not apply.

The performance testing mentioned (ASTM F543-13 Standard and ASTM F2193-14 Standard) relates to the physical and mechanical properties of the bone screws (e.g., torsional strength, axial pullout strength, bending strength). These standards are for assessing the structural integrity and performance of the hardware itself, not for evaluating an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot provide the information requested in the prompt because the available text does not describe an AI/SaMD and thus lacks the relevant data concerning:

1. A table of acceptance criteria and reported device performance (for an AI/SaMD): The document lists mechanical tests, not AI performance metrics.
2. Sample size used for the test set and data provenance: No test set for an AI algorithm is mentioned.
3. Number of experts used to establish ground truth: Not applicable for a mechanical device.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document indicates that the device's substantial equivalence is based on its similarity in design, material, and indications for use to a previously cleared predicate device (K153656), along with adherence to established mechanical testing standards for bone fixation devices.

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