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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 screw indications are limited to the sacrum only.

1. The ZODIAC™ Spinal Fixation System when used as a hook and sacral 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™ Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral 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™ Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The ZODIAC™ 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, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The ZODIAC™ Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are offered in titanium alloy, Ti-6Al-4V ELI (ASTM F 136). System rods are also available in commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for stainless steel (ASTM F 138) system components.

The ZODIAC™ Spinal Fixation System is a medical device, and the provided text is a 510(k) summary for its clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context. The "study" here is primarily a performance data study to characterize the physical properties of the device, specifically the stainless steel components, and show they are equivalent to the previously cleared titanium alloy version.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the summary. This would refer to the number of components or constructs tested in engineering bench studies, not patient data.
• Data Provenance: Not applicable in terms of country of origin for patient data. The "data" are results from mechanical and material testing conducted on the device components. This would typically be laboratory data.
• Retrospective or Prospective: Not applicable. This refers to engineering test data, not clinical patient data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not applicable. Ground truth in this context refers to established material science and biomechanical engineering standards used to evaluate device performance.
• Qualifications of Experts: Not applicable. Evaluation would be against established engineering standards and specifications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Decision-making is based on comparing test results against established engineering standards and specifications for substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This is a medical device for spinal fixation, not a diagnostic imaging or AI-assisted interpretation device. The study type is focused on mechanical and material properties.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study: Not applicable. There is no algorithm or AI component to this physical medical device. The "performance data" refers to the mechanical and material testing of the physical components.

7. Type of Ground Truth Used:

• Ground Truth: Engineering and material science standards, biomechanical testing criteria, and established performance characteristics of the predicate titanium alloy ZODIAC™ Spinal Fixation System. The "ground truth" for the new stainless steel components is that their performance must meet or exceed the performance of the predicate device to ensure substantial equivalence.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no AI or machine learning component requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• How Ground Truth Was Established: Not applicable. No training set is involved.

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