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The Zeus Spinal System is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studes); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor, pseuudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the Zeus Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion

The Zeus Spinal System is a modification of the previously cleared Adena-Zina Spinal System which consists of a variety of shapes and sizes of screws and Ø5.35mm rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include the originally cleared (K152781) straight and pre-bent rods, fixed and fixed angle reduction screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066). The subject submission seeks to add new Ø5.5mm pre-bend rods, single head and dual head polyaxial (multi-axial) screws, dual head reduction screws, polyaxial reduction screws (fixed polyaxial fixed screws, dual head monoaxial (fixed) screws, cannulated reduction screws (multiaxial and monoaxial), coronal and sagittal uniplanar screws, preferable angle screws, iliac screws, monoaxial Screw, associated set screws, connector and Ø5.5mm crosslinks, as well as additional sizes of existing components and cobalt chrome tulips for associated screws.

The provided text describes a 510(k) premarket notification for the "Zeus Spinal System," a thoracolumbosacral pedicle screw system. This document focuses on demonstrating substantial equivalence to predicate devices through bench performance testing of the device itself (implants), rather than evaluating the performance of an AI/software component in a human-in-the-loop or standalone study with a ground truth established by experts.

Therefore, many of the typical acceptance criteria and study details relevant to AI/software device performance (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission as described.

Here's a breakdown based on the provided text:

Subject of Evaluation: Physical medical device (spinal implants and their mechanical performance), not an AI/software algorithm.

Type of Study: Bench performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance bench testing was performed "per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and "per ASTM F1798 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used in Spinal Arthrodesis Implants."

While the specific numerical acceptance criteria and reported performance values are not explicitly detailed in this public summary, the conclusion states: "performance bench testing had been performed and shows that the subject Zeus Spinal System performs equivalent to or better than the primary predicate device."

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

• Sample Size: Not specified in the document. For bench testing of physical devices, sample sizes are typically defined by engineering standards (like ASTM) to ensure statistical significance for mechanical properties.
• Data Provenance: Not applicable in the context of clinical data. This is mechanical testing of manufactured devices in a lab setting.

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

• Not applicable. Ground truth for mechanical device performance is established by standardized testing protocols and measurements, not by expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set:

• Not applicable. No expert adjudication of clinical data is involved.

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. This is not an AI-assisted diagnostic or clinical decision support device.

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

• Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

• Bench Testing Standards/Specifications: The "ground truth" for the device's mechanical performance is defined by the requirements outlined in the ASTM F1717 and ASTM F1798 standards, and comparison to the performance of the predicate device. These standards specify how the device should perform under various loads and conditions.

8. The Sample Size for the Training Set:

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

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

• Not applicable. No training set is involved.

In summary: The provided document is a regulatory submission for a physical medical device (spinal system) based on material and mechanical performance equivalency to predicate devices, conducted via standardized bench testing. It does not involve AI or software performance evaluation, and thus, metrics related to clinical data, expert review, or machine learning model performance are not relevant or present in this specific regulatory summary.

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