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The LEXUS Cervical Fixation System is indicated for the following:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and . radiographic studies)
• . Spondylolisthesis
• . Spinal stenosis
• . Fracture/dislocation
• . Failed previous fusion
• . ' Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, rods, set screws, and hooks.

Materials: All products are made of titanium alloy (Ti-6Al-4V ELI/ in conformance with ASTM F136) approved for medical use.

The LEXUS Cervical Fixation System's performance was evaluated through mechanical testing according to ASTM F1717 standards, which outlines methods for static and dynamic tests of spinal implant constructs in a vertebral body model.

1. Acceptance Criteria and Reported Device Performance:

Note: The provided document states that the device was "tested according to the ASTM F1717", and that it is "considered substantially equivalent to other legally marketed devices" and "expected to be equivalent in safety and effectiveness." This implies that the device met the performance requirements specified in the ASTM F1717 standard, which serve as the acceptance criteria for mechanical performance for such spinal fixation systems. Specific numerical acceptance criteria and actual reported performance values are not detailed in this summary.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: Not specified in the provided document. As this is mechanical testing, the "sample size" would refer to the number of physical devices or constructs tested for each mechanical test.
• Data Provenance: The testing was conducted by or for L&K BIOMED Co., Ltd., based in the Republic of Korea. The document does not specify the location of the testing laboratory (e.g., in-house, third-party, country). This is a technical performance study, not a clinical study involving human patients.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

• Not applicable. This study focuses on the mechanical performance of the device, not a diagnostic or prognostic assessment requiring expert medical opinion for ground truth.

4. Adjudication Method for Test Set:

• Not applicable. This is a mechanical engineering test, not a clinical study requiring adjudication of expert opinions.

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

• Not applicable. This is a submission for a physical medical device (spinal fixation system) and its mechanical performance, not an AI or imaging-based diagnostic device. Therefore, no MRMC study was performed.

6. Standalone Performance Study:

• Yes, a standalone study was performed in the sense that the device's mechanical performance was tested independently of its clinical implantation or interaction with human readers. The tests (Static/Dynamic Axial Compression, Static Tension, Static Torsion) evaluated the device itself.

7. Type of Ground Truth Used:

• The "ground truth" for this study is defined by the objective physical and mechanical properties and behaviors of the device as measured against the industry standard (ASTM F1717). This includes parameters like strength, stiffness, and fatigue life under specified loading conditions.

8. Sample Size for Training Set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable. As this is not a machine learning or AI device, there is no training set and therefore no ground truth establishment for a training set.

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