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510(k) Data Aggregation
(29 days)
The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.
The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, 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; deformities or curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.
The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The modifications contained herein consist of the addition of pedicle screw sizes to the SFS system.
The provided 510(k) summary for the Lanx Spinal Fixation System (K122145) describes a device modification, specifically the inclusion of additional pedicle screw sizes. As such, the submission primarily focuses on demonstrating substantial equivalence to the previously cleared predicate device rather than conducting a de novo study with acceptance criteria and a detailed comparative study for a novel device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not provide a table of explicit, quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit, quantitative acceptance criteria are provided in the document. The basis for clearance is "Substantial Equivalence." | "Engineering analysis demonstrates that there is no change to the safety and efficacy of the system with the addition of alternate pedicle screw sizes." |
| "The Lanx Spinal Fixation System functions as intended and demonstrates substantial equivalence to the predicate device." | |
| "Engineering analyses also demonstrated comparable mechanical properties to the previously cleared Lanx Spinal Fixation System." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Engineering analysis" and "Engineering analyses" but does not specify:
- The sample size of any test set (e.g., number of pedicle screws or constructs tested).
- The data provenance (e.g., country of origin, retrospective or prospective nature).
These analyses would typically involve mechanical testing (e.g., fatigue, static strength) of various screw sizes and configurations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is not applicable to this 510(k) submission. For a device modification like this, where the focus is on mechanical properties and substantial equivalence, "ground truth" established by experts in an clinical or imaging context is not relevant. The "ground truth" would be established by engineering standards and test methodologies.
4. Adjudication Method for the Test Set:
This is not applicable for the type of engineering analysis described. Adjudication methods (like 2+1, 3+1) are typically used for clinical or image-based studies where multiple readers assess outputs against a reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation devices, not for a spinal fixation system modification focused on mechanical properties. Thus, there is no mention of the effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
No, a standalone study was not done. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used:
The "ground truth" for this submission is based on engineering standards and established mechanical test methodologies to evaluate the mechanical performance of the pedicle screws and the overall system. The comparison is made against the predicate device's known performance and relevant ASTM or ISO standards for spinal implants.
8. The Sample Size for the Training Set:
This concept is not applicable to this submission. The device is not an AI/machine learning model that requires a "training set." The engineering analyses performed are deterministic mechanical tests.
9. How the Ground Truth for the Training Set was Established:
This is not applicable as there is no "training set" for this device.
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