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The ART Posterior Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as a n adjurce to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system ART Posterior Spinal System is indicated for the 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 lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The hooks are intended for posterior, nonpedicle screw fixation of the noncervical spine; hook and sacral/iliac screw fixation to the noncervical spine; and hook and sacral screw fixation to the T1-S1 spine.

Pedicle Screws, monoaxial and polyaxial, are available in various lengths and diameters. The Screw is connected to Federe Screws, nonoaxian and polyamin, are a in lengths ranging from 40mm to 500mm. The Screw is inserted the Rod Via a Not Connector and inserted in the bone. As a top loading system the Connector has a Uthrough an opening the Rod. The interior of the U-shaped opening in the Connector is threaded to accept a Shaped Opening that accepts the Rod. The Connector. The necessity for rod bending is reduced by the ability to vary the angle between the screw and connector up to 20°.

A rod connector component, called a Domino, attaches two rods for use in multi-level fusions. Rods can be connected in series or parallel.

A Cross Connector, of varying lengths, attaches to the rods to provide rotational stability to the construct.

Pedicle, laminar and transverse hooks are also part of the system. The rods attach to the hooks and can be used for single or multiple level fixations.

The provided text is a 510(k) summary for a spinal implant system and does not contain any information about an AI/ML device or its performance characteristics.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, or comparative effectiveness studies related to an AI/ML device.

The document describes a "ART Posterior Spinal System" which is a physical medical device (pedicle screw system) and the summary refers to performance testing done according to ASTM F1717, an international standard for spinal implant testing. This standard typically involves mechanical testing of the device rather than clinical performance studies with human subjects or AI/ML algorithm evaluations.

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