(62 days)
The Lanx Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system consists of a series of polyaxial screws, rods, cross connectors and interlocking mechanisms. The components are manufactured from alloyed titanium. This submission is intended to address a line extension to the Lanx Spinal Fixation System. The line extension includes additional pedicle screw sizes/configurations, hooks, connectors and the introduction of unalloyed titanium rods.
This document, K071633, is a 510(k) summary for a medical device (Lanx Deformity System - a spinal fixation system) and does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the way typically associated with AI/ML diagnostic devices.
Instead, this 510(k) submission is for a line extension of an existing spinal fixation system. For such devices, acceptance criteria and "studies" usually refer to mechanical testing to demonstrate performance and equivalence to a predicate device for regulatory approval, rather than clinical studies with human participants or AI/ML model performance metrics.
Here's a breakdown based on the provided text, and where your requested information would typically not apply to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied): Mechanical properties comparable to the predicate device.
- Reported Device Performance: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."
| Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties comparable to predicate device | Achieved; mechanical testing demonstrated comparability. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a hardware submission, not based on a "test set" of patient data for AI/ML. The "test set" would be the physical samples of the device undergoing mechanical testing. The specific number of samples tested is not mentioned in this summary but would be detailed in the full test report. Data provenance (country of origin, retrospective/prospective) is irrelevant in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in this context would be engineering specifications and standards for mechanical testing, verified by qualified engineers, not medical experts.
4. Adjudication method for the test set:
- Not Applicable. Mechanical testing results are compared against established engineering standards or predicate device performance, not adjudicated by multiple reviewers in a clinical sense.
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 is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used:
- For mechanical testing, the "ground truth" would be established engineering standards, material specifications, and performance data from the predicate device.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device. There is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable.
Summary of the Study (as described in the 510(k) summary):
The "study" refers to mechanical testing that was conducted on the Lanx Deformity System to demonstrate that its components (new pedicle screw sizes/configurations, hooks, connectors, and unalloyed titanium rods) have "comparable mechanical properties" to the predicate device (Lanx Spinal Fixation System, K043484). The core argument for substantial equivalence is that "The minor differences in the line item extensions items do not raise any new questions of safety or effectiveness" and are supported by this mechanical testing.
In essence, the "acceptance criterion" for this submission was demonstrating that the new elements of the system perform mechanically at a level equivalent to the already approved predicate device, thereby ensuring safety and effectiveness.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.