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The Overwatch Spine System is intended for non-cervical fixation (T1-S2/Ilium) in skeletally mature patients as an adjunct to following instabilities/deformities in the thoracolumbar and sacral spine: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c) trauma (i.e., fracture or dislocation), d) spinal stenosis, e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). f) tumor, g) pseudoarthrosis, and h) failed previous fusion The Overwatch Spine System is intended for the following indications when used in a posterior percutaneous approach for non-cervical pedicle and non-pedical fixation: Degenerative disc disease; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6Al-4V (ASTM F136).

The provided document is a 510(k) premarket notification for a medical device called the "Overwatch Spine System." It describes the device, its intended use, and a summary of performance testing to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device. The "Summary of Performance Testing" section refers to mechanical testing of the spinal fixation system, not a clinical study involving data provenance, expert ground truth, sample sizes for training/test sets, or comparative effectiveness studies with human readers.

Therefore, I cannot provide the requested information for an AI/ML context based on this document. The document focuses on the mechanical and material equivalence of a physical medical device.

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