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The ORTHROS™ MIS Posterior Stabilization System, when used in a posterior percutaneous approach 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), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). In addition, ORTHROS™ MIS Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L-3sacrum/ilium.

The ORTHROS™ Posterior Stabilization 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). In addition, the ORTHROS™ Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

The ORTHROS™ Posterior Stabilization System is a multiple component, posterior stabilization system which consists of a variety of shapes and sizes of rods, monoaxial screws, polyaxial screws, cannulated polyaxial screws, reduction screws, cannulated reduction screws, locking caps, locking set screws, cross links, and associated manual surgical instruments. The ORTHROS™ Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior and anterior use. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking Caps and Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136.

The ORTHROS™ MIS Posterior Stabilization System is a multiple component, minimally invasive posterior stabilization system which consists of a variety of shapes and sizes of rods, cannulated percutaneous/MIS polyaxial screws, locking set screws, and associated manual surgical instruments. The ORTHROS™ MIS Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. The MIS polyaxial screws are intended for posterior use. Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136. The ORTHROS™ MIS System also utilizes select instrumentation from the ORTHROS™ Posterior Stabilization System.

The provided text describes a 510(k) submission for the ORTHROS™ Posterior Stabilization System and the ORTHROS™ MIS Posterior Stabilization System. This document focuses on demonstrating substantial equivalence to predicate devices for a spinal implant system and does not contain information related to an AI/ML device.

Therefore, I cannot extract the requested information about acceptance criteria and study details for an AI device, as these are not relevant to the content provided. The "Performance Data" section specifically refers to mechanical testing of the spinal implant, not performance of a software algorithm.

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