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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 Pedicle Screw 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 Pedicle Screw 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 Pedicle Screw 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 Pedicle Screw 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 Pedicle Screw System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti6Al-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). The ZODIAC Polyaxial Pedicle Screw System is designed to facilitate optimal screw and rod placement.

The provided text describes a medical device, the ZODIAC Polyaxial Pedicle Screw System, and its clearance through the 510(k) pathway. This pathway establishes substantial equivalence to already marketed predicate devices, primarily through performance data demonstrating comparable safety and effectiveness.

However, the 510(k) summary does not contain the level of detail requested for a typical AI/software device study (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, standalone performance). This is because the ZODIAC system is a mechanical implant, and its performance evaluation relies on different methodologies, primarily mechanical and dynamic testing, rather than clinical efficacy studies with human readers or AI algorithms.

Therefore, many of the specific questions cannot be answered from the provided document. I will extract what information is present and indicate where the requested information is not available.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" for a mechanical device like the ZODIAC system are met by demonstrating structural integrity and comparable mechanical performance to predicate devices. The document focuses on demonstrating substantial equivalence rather than listing specific numerical acceptance criteria.

Missing Information: Specific numerical thresholds for mechanical strength, fatigue life, or other mechanical properties that would constitute "acceptance criteria" are not provided in this 510(k) summary. These would typically be found in detailed test reports, not the summary itself.

Study Details (Based on Provided Text)

1. Sample size used for the test set and the data provenance: Not applicable in the context of mechanical testing. The "test set" would refer to the number of devices or components tested. This number is not specified in the 510(k) summary. The data provenance would be from laboratory testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For mechanical testing of implantable devices, "ground truth" is established through physical measurement and engineering analysis, not expert interpretation of data relevant to AI performance.

3. Adjudication method for the test set: Not applicable. Mechanical testing results are objective measurements and do not typically require adjudication in the way clinical diagnostic interpretations do.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpretation, which is not the function of a pedicle screw system.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this is not applicable. The device is a mechanical implant, not an algorithm.

6. The type of ground truth used: For mechanical performance, the ground truth is derived from direct physical measurements (e.g., load-to-failure, cycles to fatigue) obtained in laboratory settings according to established industry standards or internal protocols.

7. The sample size for the training set: Not applicable. As a mechanical device, there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles and prior device experience, not by a data-driven training set.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Summary of Non-Applicability:

The requested detailed information regarding acceptance criteria, study sample sizes, expert ground truth, and AI-specific study methodologies (MRMC, standalone performance, training sets) is largely not applicable to the ZODIAC Polyaxial Pedicle Screw System as described in this 510(k) summary. This is because it is a physical medical implant, and its regulatory clearance relies on demonstrating substantial equivalence through mechanical and dynamic testing against predicate devices, rather than clinical efficacy studies involving diagnostic interpretations or AI performance. The provided text indicates that mechanical and dynamic testing was performed and that the results demonstrated comparability to predicate devices.

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