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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.

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).

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).
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.

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).

Device Description

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.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the Zodiac® Polyaxial Spinal Fixation System. This is a medical device, and the acceptance criteria and study described are for mechanical performance testing rather than an AI/ML-driven device with performance metrics like sensitivity, specificity, or AUC.

Therefore, the requested AI-specific information (like sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, types of ground truth, etc.) is not applicable to this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Safety and effectiveness for intended use	Mechanical and dynamic testing provides reasonable assurance of safety and effectiveness.
Compliance with recognized consensus standards	Performance testing was performed per recognized consensus standards and the guidance document, "Spinal System 510(k)s - Guidance for Industry and FDA Staff."
Adequacy of static performance characteristics	Testing documented static performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation.
Adequacy of fatigue performance characteristics	Testing documented fatigue performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation.
Substantial equivalence to predicate devices (mechanical performance)	The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is 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 (K033090, K042673, K051286, K071890).

2. Sample size used for the test set and the data provenance

Not Applicable: This document focuses on mechanical testing of a physical medical device, not a data-driven AI/ML model where test set sample sizes and data provenance are relevant in the same way. The "test set" would refer to the physical devices or components subjected to mechanical stress. The document does not specify the number of devices tested, but it implies standard engineering testing procedures.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: "Ground truth" in the context of AI/ML refers to accurately labeled data. For mechanical testing, the "ground truth" is established by adherence to engineering standards and validated testing methodologies, not expert labeling. The experts involved would be engineers and regulatory bodies evaluating the test results against established safety and performance benchmarks.

4. Adjudication method for the test set

Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert labeling for AI/ML ground truth. For mechanical testing, adherence to standards and test protocols is the primary method of validation.

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

Not Applicable: MRMC studies are specific to AI/ML devices that impact human reader performance (e.g., diagnostic image interpretation). This document is about a physical spinal fixation system.

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

Not Applicable: This refers to the performance of an AI algorithm on its own. The Zodiac® system is a physical implant, not an algorithm.

7. The type of ground truth used

Engineering Standards and Test Protocols: For mechanical devices, the "ground truth" is defined by established engineering and regulatory performance standards (e.g., ISO, ASTM, or FDA-recognized consensus standards for spinal implants) and rigorous test protocols. The device's performance is compared against these predefined physical limits and requirements.

8. The sample size for the training set

Not Applicable: "Training set" refers to data used to train an AI/ML model. This is a physical device, so no training set in that sense is involved.

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

Not Applicable: As there's no AI/ML training set, this question is irrelevant.

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