Search Results

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 purpose of this 510(k) submission is to add reduction polyaxial screws and curved rods. The LEXUS Cervical Spinal Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, reduction poly screws, straight rods, curved rods, set screws, and hooks.

Materials: All products are made of titanium alloy (Ti-6A1-4V ELI/ in conformance with ASTM F136) approved for medical use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the LEXUS Cervical Fixation System:

This device (LEXUS Cervical Fixation System) is a Spinal Fixation System, and its "performance" is evaluated based on mechanical testing, not on parameters usually associated with AI/software devices (like sensitivity, specificity, or accuracy in diagnosing conditions). Therefore, many of the typical questions for AI medical devices (like expert adjudication, MRMC studies, training set details, etc.) are not applicable to this type of medical device submission.

The acceptance criteria here relate to the structural integrity and mechanical properties of the implants.

Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" for this physical device are the standards set by ASTM F1717 for spinal fixation systems. The "reported device performance" indicates that the device was tested against and found to meet these established standards. The submission asserts that because it meets these recognized consensus standards, it is substantially equivalent in safety and effectiveness to predicate devices.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in terms of a number of physical implants, but mechanical testing typically involves a sufficient number of samples to ensure statistical validity for the specific tests outlined in ASTM F1717.
   • Data Provenance: The testing was conducted in the context of the manufacturer's submission for regulatory approval. The country of origin for the device manufacturer is South Korea. The study is prospective in the sense that the sponsor conducted the tests specifically for this submission.

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

   • Not Applicable. For a mechanical device, ground truth in terms of clinical diagnosis or interpretation by experts is not relevant. The "ground truth" for mechanical testing is established by the specifications and methodologies defined in the ASTM F1717 standard itself. The results are physical measurements, not expert interpretations.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication methods are used for expert disagreements on qualitative assessments (e.g., image interpretation). This is a mechanical performance test.

4. 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/software device and does not involve human readers interpreting data.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" is adherence to the mechanical performance standards and methodologies specified by ASTM F1717. This includes physical properties like strength, stiffness, and resistance to fatigue under various loads, which are measured objectively.

7. The sample size for the training set:

   • Not Applicable. This is a hardware medical device, not a machine learning model; therefore, there is no "training set."

8. How the ground truth for the training set was established:

   • Not Applicable.

Summary of Device Performance Claim:

The L&K BIOMED LEXUS Cervical Fixation System's performance and safety are demonstrated by its compliance with internationally recognized mechanical testing standards (ASTM F1717). This standard evaluates static and dynamic axial compression, static tension, and static torsion. By meeting these benchmarks, the manufacturer asserts substantial equivalence to predicate devices, implying its safety and effectiveness for its intended use as a spinal fixation system.

Ask a specific question about this device