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The Omnia Medical PsiF DNA™ System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The PsiF DNA™ may be implanted via a transverse or inline approach. When PsiF DNA™ is implanted inline, it must be used with a PsiF DNA™ screw implanted transversely across the same sacroiliac joint.

The Omnia Medical PsiF DNA™ System consists of screws and washers manufactured from Ti-6Al-4V ELI per ASTM F3001 and ASTM F136, respectively. The screws are available in one diameter and a variety of lengths to accommodate varying patient anatomy. The system includes instrumentation for implantation that is manufactured from surgical grade stainless steel or aluminum. During the procedure, the implant is inserted through the ilium to pierce its medial cortex, across the sacroiliac joint and into the sacrum to pierce its lateral cortex, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery. The implants and instruments are provided in two surgical kit options. In one kit, the implants and instruments are provided non-sterile and sterilized by the end user. In the other kit, the implants and instruments are single-use and provided sterile.

Based on the provided FDA 510(k) clearance letter for the Omnia Medical PsiF DNA™ System, there is no information about specific acceptance criteria or a study that proves the device meets those criteria in the context of AI/Software performance.

The clearance letter focuses on the device being a physical medical device (a bone fixation fastener) and its substantial equivalence to predicate devices based on mechanical and cadaveric testing.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria for a device, a test set, expert ground truth, MRMC studies, or training sets, as these concepts are typically applied to the evaluation of software as a medical device (SaMD) or AI-enabled medical devices, not to a physical implant like the Omnia Medical PsiF DNA™ System.

The document explicitly states:

• "Clinical testing was not required to support a substantial equivalence determination for the PsiF DNA™ device." This confirms that there was no clinical study, let alone one focused on human-in-the-loop performance or AI assistance.
• The non-clinical testing listed consists entirely of mechanical and cadaveric tests, which are standard for orthopedic implants to assess their structural integrity, strength, and biomechanical compatibility.

In summary, none of the requested information (table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, ground truth types) is present in this 510(k) document because the cleared device is a physical implant, not an AI/software product requiring such performance evaluation.

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