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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™ Polyaxial 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™ Polyaxial 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™ Polyaxial 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™ 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, 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™ Polyaxial Spinal Fixation System is a top loading anterior/posterior spinal fixation system consisting of various types and sizes of implantable components that are assembled to create a rigid spinal construct.

The provided text is a 510(k) summary for a medical device, the ZODIAC™ Polyaxial Spinal Fixation System, seeking clearance from the FDA. It is not a study that proves the device meets acceptance criteria in the way a clinical trial or AI performance study would.

Instead, this document establishes substantial equivalence to existing predicate devices based on mechanical and dynamic testing. The "acceptance criteria" here are implied to be the performance characteristics of the predicate device, which the new device must match or exceed.

Here's the breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria (Implied)	Reported Device Performance
   Mechanical performance comparable to predicate device (MOSS Miami Spinal Fixation System)	"The test results demonstrate that the mechanical performance of the Zodiac 4.0 Polyaxial Spinal Fixation System is substantially equivalent to the predicate device."
   Dynamic performance comparable to predicate device (MOSS Miami Spinal Fixation System)	"The test results demonstrate that the mechanical performance of the Zodiac 4.0 Polyaxial Spinal Fixation System is substantially equivalent to the predicate device."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified. The document only states "Mechanical and dynamic testing... was performed." It does not provide details on the number of samples tested for each type of component or for the system as a whole.
   • Data Provenance: Not specified. It's internal testing conducted by the manufacturer, Alphatec Spine, Inc., based in Carlsbad, CA, USA, but the specific location of the testing facility or the origin of the materials/components is not detailed. The testing is inherently prospective as it's performed to demonstrate equivalence for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. This summary refers to mechanical and dynamic engineering testing of a physical medical device, not a diagnostic or AI-driven device requiring expert-established ground truth from medical images or clinical data. The "ground truth" here is the measured mechanical properties of the device and its predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. See point 3. Mechanical testing results are typically objective measurements, not subject to medical expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No. This is a physical spinal fixation system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No. This is a physical spinal fixation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Mechanical properties and performance standards. The "ground truth" for this device's performance is the established mechanical and dynamic performance of the predicate device, measured against industry standards (likely ISO or ASTM standards for implantable devices, though not explicitly stated in the summary).

8. The sample size for the training set

   • Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

   • Not applicable. See point 8.

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