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The Expedium MIS Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a percutaneous, posterior approach with MIS instrumentation, the Expedium MIS System screw components are intended for noncervical pedicle fixation and nonpedicle fixation 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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The Expedium MIS System consists of cannulated polyaxial pedicle screws and 5.5mm rods in various lengths. The Expedium MIS System also contains Class 1 manual surgical instruments to aid in the percutaneous approach, and cases that are considered exempt from premarket notification.

The provided text is a 510(k) summary for the DePuy Spine, Inc. Expedium™ MIS Spine System. It describes the device, its intended use, materials, and states that "Performance data were submitted to characterize the notched rod with the cannulated polyaxial screws."

However, this document does not contain specific acceptance criteria, reported device performance (numerical or otherwise), details about study designs (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or information regarding MRMC studies or standalone algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document only mentions that performance data were submitted but does not present them.

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