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The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged lag or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm - 14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm- 110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm - 14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies involving a test set, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training sets.

The document is a 510(k) premarket notification from the FDA for the Zyga Technology, Incorporated's SImmetry® Sacroiliac Joint Fusion System. It discusses the device's classification, predicate devices, description, intended use, and a summary of non-clinical performance data.

The "Summary of Non-clinical Performance Data" section mentions:

• "Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K130092 predicate device."
• "Cadaveric testing demonstrates the subject devices can be safely implanted using the SImmetry surgical technique."
• "Additionally testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure."

However, it does not provide any specific acceptance criteria or detailed results of these tests (e.g., numerical values for torque, strength, or fatigue life). There's no mention of a test set, data provenance, experts, ground truth, or any methodology typically associated with validating an AI/ML medical device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about the studies as described in your prompt, as that information is not present in the provided text.

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