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The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.

1. The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:

a. Patients having fractures of the thoracic and lumbar spine.

b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity).

c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

2. The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

3. In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:

a. Patients receiving autograft or allograft bone.

b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.

4. The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:

a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis,

kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity).

c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).

The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.

The provided document is a 510(k) summary for the Zodiac® Polyaxial Spinal Fixation System. It describes a medical device, not a diagnostic or AI-powered device. Therefore, the questions related to the performance of an AI/diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable.

The "Performance Data" section in the document states:
"Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. The testing demonstrated that additional components are substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices."

This indicates that the device's performance was evaluated through mechanical and dynamic testing to demonstrate its substantial equivalence to previously cleared predicate devices. The acceptance criteria for such a device would typically involve meeting established engineering and biocompatibility standards for spinal implants, ensuring the device can withstand the physiological stresses of its intended use. However, the specific quantitative acceptance criteria (e.g., specific load capacities, fatigue limits, etc.) and the detailed results of these tests are not provided in this 510(k) summary.

Therefore, based solely on the provided text, I cannot answer the questions as they pertain to AI/diagnostic device performance because this document describes a physical spinal fixation system.

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