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The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterical fixation in sketally mature patients as an adjunct to fusion for the following indications:

· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

·Spondylolisthesis;

·Trauma (i.e., fracture or dislocation);

·Spinal stenosis;

·Curvatures (i.e., scoliosis, kyphosis and/or lordosis);

·Tumor and pseudarthrosis

Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of rods, connectors and screws for implantation in the spine. The system is available in multiple rod diameters and screw sizes.

The provided document describes the Auxein Brand Vertaux 5.5 mm Pedicle Screw System and its substantial equivalence to a predicate device (K091442, Medtronic Sofamor Danek, USA, CD HORIZON Spinal System). The acceptance criteria and the study proving the device meets these criteria are outlined primarily through a comparison with the predicate device and non-clinical testing.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly defined by the equivalence to the predicate device and compliance with established performance and material standards. The device performance is reported as meeting these standards and being "equivalent" to the predicate.

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

The document describes non-clinical testing for the Auxein Brand Vertaux 5.5 mm Pedicle Screw System.

• Sample Size for Test Set: Not explicitly stated as a number of devices or constructs. The testing refers to "Applicable standards" and "Relevant test results" for materials and "Static compression testing," "Static Torsional Testing," and "Fatigue Compression testing" as per ASTM F 1717-18 for performance. These standards typically involve specific numbers of specimens, but those numbers are not detailed in this submission.
• Data Provenance: The testing was conducted for the Auxein Brand Vertaux 5.5 mm Pedicle Screw System to demonstrate compliance with ASTM standards. This is prospective testing performed for the purpose of this submission. The origin of the data is internal testing or outsourced testing to laboratories demonstrating compliance with the specified ASTM standards. No mention of country of origin for the test data specifically, beyond the company's location in India.

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

This information is not applicable to this type of submission. This document describes a medical device (pedicle screw system) which is evaluated primarily through engineering and material testing standards, and comparison to existing predicate devices, rather than human expert interpretation of diagnostic images or clinical outcomes that would require ground truth establishment by experts.

The submission is a 510(k) for substantial equivalence, relying on:

• Non-clinical mechanical and material testing.
• Comparison of technological characteristics and intended use to a legally marketed predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable as it's not a clinical study involving human interpretation or outcome assessment requiring adjudication. The "test set" here refers to the physical devices undergoing mechanical and material testing, which are evaluated against predefined pass/fail criteria from the ASTM standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or referenced in this document. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiology AI tools). This submission is for an implantable surgical device evaluated by engineering standards, not diagnostic interpretative tasks.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not Applicable. This device is a pedicle screw system, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical testing is defined by the acceptance criteria and methodologies outlined in the referenced ASTM standards (ASTM F 136, ASTM F 899-12, ASTM F 1717-18). These standards define the parameters, test methods, and acceptable ranges or failure modes for the materials and mechanical performance of spinal implant constructs. For the comparative analysis, the "ground truth" is the characteristics of the predicate device (CD HORIZON Spinal System, K091442) to which substantial equivalence is claimed.

8. Sample Size for the Training Set:

Not Applicable. This submission is for a physical medical device (implantable pedicle screw system), not a software or AI device that requires a "training set."

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

Not Applicable. As no training set is involved for this type of medical device submission.

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