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The Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

The Spineology Threshold ™ Pedicular Fixation System is an addition to Spineology's Fortress pedicle screw family. The Threshold System consists of cannulated titanium screws and rods to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.

The provided text is a 510(k) summary for the Spineology Threshold™ Pedicular Fixation System. It describes a medical device, a pedicle screw spinal system, and does not contain information about an AI/ML device or its performance criteria. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML system.

The document discusses the substantial equivalence of the Threshold™ Pedicular Fixation System to a predicate device (Spineology Fortress™ Pedicle Screw System) based on intended use, materials, technological features, and comparative performance testing, specifically "Static testing ... performed to verify the design and demonstrate that the Threshold Pedicular Fixation System is substantially equivalent to the Fortress Pedicle Screw System. The performance testing included static compression loading in accordance with ASTM F1717."

This is a physical medical device, not an AI/ML algorithm.

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