(53 days)
The LEXUS Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis,
- trauma (i.e. fractures or dislocations),
- tumors.
- deformity (defined as kyphosis, lordosis or scoliosis),
- pseudarthrosis,
- failed previous fusion,
- spinal stenosis.
The LEXUS Anterior Cervical Plate System is composed of plates and screws which are made from titanium alloy Ti-6A1-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates range in length to accommodate one, two, three, and four level procedures. The screws in the LEXUS Anterior Cervical Plate System are 3.5mm and 4.0mm diameter bone screws. They are fixed self-tapping, variable selftapping, fixed self-drilling, variable self-drilling and are available in lengths ranging from 12 to 20mm.
This document describes the LEXUS Anterior Cervical Plate System's acceptance criteria and the study conducted to prove it meets them.
Acceptance Criteria and Device Performance
The acceptance criteria for the LEXUS Anterior Cervical Plate System were established through non-clinical mechanical testing and comparison to legally marketed predicate devices. The primary goal was to demonstrate substantial equivalence in performance and safety.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Performance "as well as the predicate device" in: Static Compression Bending, Tension, Torsion, Dynamic Compression Bending (all performed according to ASTM F1717 standard on a worst-case construct). | The mechanical test results "demonstrated that the LEXUS Anterior Cervical Plate System performs as well as the predicate device." |
| Material Equivalence | Composed of the same materials (titanium alloy Ti-6A1-4V ELI (ASTM F136)) as predicate devices. | The LEXUS Anterior Cervical Plate System is described as having "the same materials" as the predicate devices. |
| Design Equivalence | Similar design characteristics to predicate devices. | The LEXUS Anterior Cervical Plate System shares "similar design" characteristics with the predicate devices. |
| Intended Use Equivalence | Same intended use as predicate devices (anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion for a specified list of conditions). | The LEXUS Anterior Cervical Plate System has the "same intended use" as the predicate devices and the described indications match those expected for such a device. |
Study Details
Based on the provided information, the study conducted was a non-clinical mechanical testing study.
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Sample Size used for the test set and data provenance:
- Sample Size: Not explicitly stated as a numerical sample size. The testing was performed "on a worst-case, cervical plate construct." This implies a representative construct was used for various tests, but the exact number of units tested is not provided.
- Data Provenance: The study was non-clinical, likely conducted in a laboratory setting. The origin is L&K BIOMED Co., Ltd. (Republic of Korea). The study is prospective in the sense that the device was manufactured and then tested according to a pre-defined protocol.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. This was a mechanical engineering study, not a study involving medical experts establishing ground truth for clinical cases. The "ground truth" was the objective physical performance measured by standardized ASTM methods.
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Adjudication method for the test set:
- Not applicable. This was a mechanical engineering study based on objective measurements and comparison to a standard and a predicate device's performance.
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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:
- No. This was a non-clinical mechanical engineering study, not a clinical study involving human readers or AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm or AI.
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The type of ground truth used:
- Objective Mechanical Measurements: The ground truth was based on quantitative measurements of mechanical properties (compression bending, tension, torsion, dynamic compression bending) using established ASTM F1717 standards. The performance of the predicate device also served as a comparative ground truth.
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The sample size for the training set:
- Not applicable. This was a non-clinical mechanical study of a physical device. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.