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The PROTEX™ Stabilization System, when used as a 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), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the PROTEX™ 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 illium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the PROTEX™ Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the PROTEX™ Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The PROTEX™ Stabilization System consists of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.

The implants are composed of titanium alloy as specified in ASTM F136 and F1295.

This 510(k) pertains to a spinal stabilization system, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are specific to the evaluation of AI/ML device performance, is not applicable to this document.

The "PERFORMANCE DATA" section of the 510(k) summary (Section {1}) states:

"Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', September 27, 2000 is presented."

This indicates that the device's performance was evaluated through mechanical testing to ensure its structural integrity and functional characteristics meet established standards for spinal implants. These types of devices do not involve AI/ML components for diagnostic or predictive purposes, and thus do not have "acceptance criteria" in the context of sensitivity, specificity, AUC, or reader studies that would typically be associated with AI/ML medical devices.

The "BASIS OF SUBSTANTIAL EQUIVALENCE" (Section {1}) further clarifies that:

"The PROTEX™ Stabilization System implants are similar to the predicate Synthes USS and Click'X (K992739, K022949, K031175) thoracolumbar stabilization systems with respect to technical characteristics and performance."

This suggests that the device's acceptance criteria primarily revolve around demonstrating mechanical equivalence and adherence to the same design and material specifications as the predicate devices, as evaluated through established biomechanical testing protocols.

Therefore, I cannot provide a table of acceptance criteria and device performance, sample sizes for test sets, details on expert establishment of ground truth, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set relevant to AI/ML devices.

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