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The CONTOUR II™ Spinal System is intended for noncervical, pedicle fixation 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, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

In addition, the CONTOUR II™ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

The CONTOUR II™ Spinal System (KWP) is also intended for use as a posterior noncervical, nonpedicle system indicated for degenerative disc disease which is defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies. spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts.

When used as an anterior fixation system, the CONTOUR II™ Spinal System (KWO) is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor. pseudoarthosis, or revision of failed fusion attempts.

The CONTOUR II™ Spinal System is an anterior / posterior spinal fixation system consisting of pedicle screws, L and straight connecting rods as well as a variety of clamps and cross connectors. The CONTOUR II™ implant components are fabricated from Ti-6AI-4V ELI per ASTM F 136. Various sizes of these implants are available.

The provided document is a 510(k) summary for the CONTOUR II™ Spinal System, a medical device for spinal fixation. It details the device's indications for use, its classification, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML device.

The 510(k) process for a Class II medical device like the CONTOUR II™ Spinal System focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics and acceptance criteria from a study in the way an AI/ML device would. The "safety information" section on page 4 describes user qualifications rather than device performance.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies, training set details) is not present in the provided text.

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