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The 4CIS® Chiron Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).

The Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery or minimally invasive surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F 136 and CoCr Alloy per ASTM F1537. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System.

The provided text is a 510(k) Summary for a medical device called the "4CIS® Chiron Spinal Fixation System." It details the device's purpose, components, indications for use, and a comparison to predicate devices, including performance data. However, this document does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The "Performance Data" section explicitly states:

"Mechanical testing (static and dynamic compression bending, static tension bending, static torsion) was conducted in accordance with ASTM F1717. Above non-clinical performance data in the form of a comprehensive literature review was provided in support of substantial equivalence of the subject device to the predicate devices."

This indicates that the performance data for this spinal fixation system is based on mechanical testing to ensure its structural integrity and equivalence to existing devices, not on the performance of an AI model in interpreting or diagnosing medical images or other data.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided document pertains to a physical medical implant and its mechanical properties.

To answer your request, I would need a document related to the regulatory submission of an AI/ML-driven medical device, which would typically involve clinical performance studies assessing the algorithm's accuracy, sensitivity, specificity, and potentially its impact on human reader performance.

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