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The CoreLink NextGen Pedicle Screw 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 thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). When used for posterior non-cervical screw fixation in pediatric patients, the CoreLink NextGen Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CoreLink NextGen Pedicle Screw System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.

The NextGen Pedicle Screw System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of traditional pedicle screw assemblies or modular tulip heads with modular screw shanks with extended tab reduction tulip or closed head tulip options, cross-link connectors, set screws, and spinal rods. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. Implants in the NextGen Pedicle Screw System are manufactured from titanium alloy Ti-6Al-4V per ASTM F136 and cobalt chromium alloy Co-28Cr-6Mo per ASTM F1537.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria.

The document is a 510(k) premarket notification for a medical device called the "NextGen Pedicle Screw System." This system is described as a Thoracolumbosacral Pedicle Screw System, which provides immobilization and stabilization of spinal segments. The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, materials, component selection, component sizes, biocompatibility, and non-clinical mechanical performance data.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the provided text is about a physical medical implant device and its mechanical testing, not an AI or software device.

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