(210 days)
The Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-51) as an adjunct to fusion using autograft or allograft in skeletally mature patients 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);
- Spinal stenosis (indicated for L1- S1 only); .
- Spondylolisthesis; .
- Deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); .
- Trauma (i.e., fracture, dislocation, or subluxation); .
- . Spondylolysis;
- Tumor; .
- . Pseudoarthrosis; and/or
- . Failed previous fusion.
The Lanx Anterior Plating System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
The Lanx Anterior Plating System consists of various plates and screws 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 Lanx Anterior Plating System is intended to provide fixation of the thoracic, lumbar and/or sacral spine (T1-S1) as an adjunct to fusion.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes physical testing against a predicate device rather than specific quantitative acceptance criteria with numerical targets. The "acceptance criteria" are implied to be performance comparable to the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to predicate devices in: | The device functioned as intended. |
| - Static Axial Compression | Observed test results demonstrate substantial equivalence. |
| - Static Torsion | Comparable mechanical properties. |
| - Dynamic Axial Compression |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of constructs or specific tests, but performance testing was conducted.
- Data Provenance: The study was conducted as "Performance testing and engineering analysis." This implies laboratory testing on physical samples, rather than clinical data from a specific country or retrospective/prospective collection.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
N/A. This is a mechanical device performance study, not a study involving expert assessment of images or clinical outcomes where ground truth would be established by experts.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are relevant for studies where human experts are making categorizations or assessments. This is a mechanical performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure the impact of AI. This document describes mechanical testing of a medical device.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
N/A. This concept applies to AI/software as a medical device. The Lanx Anterior Plating System is a physical spinal fixation system. However, the mechanical testing performed can be considered "standalone" in the sense that the device's physical properties are tested directly without human intervention in its function during the test.
7. Type of Ground Truth Used
The "ground truth" for this study is the measured mechanical performance of the predicate devices according to ASTM F1717. The subject device's performance is compared against these established mechanical benchmarks.
8. Sample Size for the Training Set
N/A. This is not an AI/machine learning study, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set, this question is not applicable.
§ 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.