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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).

Adjustable bridges function as transverse connectors. Transverse connectors are used in spinal constructs to add torsional rigidity. The devices come in a range of sizes to accommodate the patient's anatomy. The transverse connectors will be used as part of the ZODIAC Polyaxial Pedicle Screw System. Components are manufactured from titenium alloy, Ti-6AI-4V ELI (ASTM F 136) or stainless steel (ASTM F138).

The provided text is a 510(k) summary for the ZODIAC™ Polyaxial Pedicle Screw System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on mechanical and dynamic testing. However, it does not contain the detailed information necessary to fully answer all the requested points about acceptance criteria and a study proving those criteria are met, particularly regarding AI performance or human reader improvements.

Here's an analysis based on the available information:

ZODIAC™ Polyaxial Pedicle Screw System - Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary implies that the acceptance criteria for this device are implicitly tied to the performance of its predicate devices. The "performance" being evaluated is mechanical and dynamic.

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

The document only states "Mechanical and dynamic testing of the transverse connectors as part of a spinal construct using the ZODIAC™ Polyaxial Pedicle Screw System was performed." It does not specify the sample size (e.g., number of constructs or individual components tested) nor the data provenance (e.g., country of origin, retrospective or prospective). This type of testing is typically conducted in a laboratory setting.

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

Not applicable. The study described is a mechanical and dynamic performance test, not a study involving human interpretation or expert ground truth as typically understood in AI/medical imaging contexts. The ground truth for such a study would be the physical properties and failure points determined by engineering standards and measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was a mechanical test, not one requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The provided text describes a mechanical and dynamic performance study, not an MRMC study comparing human readers with and without AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is mentioned.

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

No. This device is a physical medical implant (pedicle screw system), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth for the mechanical and dynamic performance testing would be the quantitative data derived from the physical testing itself, measured against established engineering standards and specifications, and compared directly to the performance of the predicate devices. This is not "expert consensus, pathology, or outcomes data" in the typical clinical sense, but rather objective physical measurement data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for the mechanical testing described.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device and study.

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