(55 days)
The Lanx Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The Lanx Anterior Cervical Plate System is suitable for use to provide temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease (neck or radicular pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between and including cervical levels C2 and C7.
Materials for components of the Lanx Anterior Cervical Plate System are implant grade materials of titanium. The materials comply with applicable standards shown below. The system components include: Instruments, Sterilizer trays, Locking caps, Cervical Plates (One Level, Two Level, Three Level, Four Level, Five Level), Bone Screws - Fixed (4.0mm Self Drilling, Self Tapping, 4.5mm Self Drilling, Self Tapping), Bone Screws - Variable (4.0mm Self Drilling, Self Tapping, 4.5mm Self Drilling, Self Tapping).
The provided document is a 510(k) premarket notification for a medical device (Lanx Anterior Cervical Plate System) and focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the results of a primary clinical study for novel performance claims.
Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not directly available in this type of submission. This document highlights mechanical and material testing to ensure safety and equivalence, but not clinical performance in the sense of accuracy, sensitivity, or specificity.
Here's the information that can be extracted or reasonably inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (Inferred from Equivalence) | Reported Device Performance/Comparison (Lanx Anterior Cervical Plate System) |
|---|---|---|
| Indications for Use | Temporary stabilization of the anterior spine while awaiting bony fusion (healing) in patients with degenerative disc disease, trauma, tumors, deformity (kyphosis, lordosis or scoliosis), or pseudoarthrosis and/or failed previous fusion between and including cervical levels C2 and C7. | SAME as predicate device (Atlantis Anterior Cervical Plate System). |
| Design | Anatomically curved metallic plate. | SAME as predicate device. |
| Sterility | Not sterile, must be autoclaved. | SAME as predicate device. Recommended sterilization: high-temperature steam autoclave, producing SAL of at least 10^-6. Validated cycle: Steam (Gravity), 270°F (134°C) for 30 minutes. |
| Plate Sizes | Equivalent range of plate sizes for 1-level to 5-level fixation (e.g., 18mm - 118mm length in 2-5mm increments). | EQUIVALENT to predicate device. |
| Screw Sizes | Equivalent range of screw sizes (e.g., 4mm & 4.5mm diameter, 10-25mm length in 1mm increments). | EQUIVALENT to predicate device. |
| Material | Titanium and Titanium Alloy (specifically ASTM F136-92/ISO 5832-3 for Titanium Alloy, ASTM F67 GR2-95/ISO 5832-2 for Titanium). | SAME as predicate device. Materials comply with applicable standards. |
| Mechanical Performance | Equivalent fatigue and static strength performance to existing anterior cervical plate systems, as demonstrated through engineering and scientific principles. No specific numerical thresholds are provided, but the claim is equivalence. | Fatigue and static testing of individual components and typical system configurations were conducted. "Test results demonstrate that the Lanx Anterior Cervical Plate System performs in a manner equivalent to other existing anterior cervical plate systems." (No specific numerical results reported in this summary). |
| Compliance with Standards | Adherence to "various voluntary performance standards" including ASTM, Standard Operating Procedures, vendor & process certification, Quality Systems Regulations, ISO materials standards, ISO 9000 series. Comply with general controls under the Food, Drug, and Cosmetic Act. | Voluntary standards utilized. Meets appropriate general controls. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance or diagnostic accuracy. The testing described is primarily mechanical/material performance testing (fatigue and static testing). The number of samples for these engineering tests is not specified in this summary.
- Data Provenance: Not applicable for clinical data. For the described mechanical testing, the data would have been generated internally by Lanx, LLC or their chosen testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission does not involve clinical data with "ground truth" established by human experts. The "ground truth" for mechanical testing would be defined by the specifications and standards (e.g., ASTM F136-92 for material strength, established mechanical testing protocols).
4. Adjudication method for the test set:
- Not applicable. This concept applies to human reader studies or clinical trials, which are not detailed in this 510(k) summary for this device.
5. 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 device is an implantable medical device (anterior cervical plate system), not a diagnostic or AI-assisted device. Therefore, no MRMC study, AI assistance, or effect size related to human reader improvement is relevant or discussed.
6. 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.
7. The type of ground truth used:
- For the mechanical and material characteristics, the "ground truth" is defined by established engineering standards and specifications (e.g., ASTM F136-92, ISO 5832-3 for materials, and "accepted engineering and scientific principals" for fatigue and static testing).
- For the claim of substantial equivalence, the "ground truth" is the characteristics and performance of the predicate device (K993855, Atlantis Anterior Cervical Plate System), as documented in its own clearance and publicly available information.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device; it is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, this 510(k) premarket notification demonstrates substantial equivalence primarily through comparison to a predicate device and mechanical/material testing against recognized industry standards, rather than clinical efficacy trials involving human subjects or advanced diagnostic performance metrics.
§ 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.