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The Xultan 5.5 Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients. The Xultan 5.5 Pedicle Screw System is intended for posterior, pedicle fixation as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine (T1-S2/ilium); degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvature (i.e., scoliosis and/or lordosis); tumor; and failed previous fusion (i.e., pseudoarthrosis).

The Xultan 5.5 Pedicle Screw System is an implant device manufactured from titanium and silicone. The screws are available cannulated or non-cannulated in various diameters and lengths to accommodate various patient anatomies. The system includes straight rods, curved rods, crosslinks, and associated instrumentation.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria. The document describes a 510(k) premarket notification for a medical device called the "Xultan 5.5 Pedicle Screw System," which is a spinal implant.

The document focuses on the substantial equivalence of this device to existing predicate devices based on:

• Indications for Use: The stated medical conditions the device is designed to treat.
• Technological Characteristics: Materials, design, and principles of operation.
• Performance Data: Results of non-clinical mechanical testing (static and dynamic axial compression bending, static torsion) according to ASTM F1717-15 standards.

There is no mention of:

• Any AI/ML component or software.
• Acceptance criteria for AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
• Clinical studies involving human-in-the-loop performance or standalone AI performance.
• Details about ground truth establishment, expert adjudication, or sample size for training/test sets related to AI/ML development.
• Any multi-reader multi-case (MRMC) studies.

Therefore, I cannot provide the requested information based on the given text.

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