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When used as a posterior, noncervical screw fixation system or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e. discogenic; back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally matrue patients, the MOSS Miami System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The MOSS Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS MIAMI System is available in either Stainless Steel or Titanium. The following components are available in Stainless Steel: longitudinal rods, monoaxial screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial connectors, staple washers and sacral extenders. The following components are available in Titanium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The design, intended use, and material of these components have been cleared in previous 510(k) submissions.

The provided text is a 510(k) summary for the DePuy AcroMed MOSS Miami Spinal System, a medical device for spinal fixation. It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

However, this document does not contain any information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, expert review, sample sizes, or comparative effectiveness for an AI/algorithm-based device. The entire document pertains to a physical spinal fixation system and its regulatory clearance based on substantial equivalence to existing predicate devices, not on the performance of a software algorithm.

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