(171 days)
When intended to promote fusion of the cervical spine and the thoracic spine (C1-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) is indicated for the following:
- · Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Spondylolisthesis
- · Spinal Stenosis
- · Fracture/Dislocation
- · Failed previous fusion
- · Tumor
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The 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 Lanx Posterior Cervicothoracic Spinal Fixation System consists of various titanium alloy screws, rods, hooks, 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 provided text describes a 510(k) premarket notification for the LANX Posterior Cervicothoracic Spinal Fixation System. This is a spinal fixation device, which typically undergoes mechanical performance testing rather than studies involving human readers or AI algorithms for diagnostic purposes. As such, many of the requested categories are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance per ASTM F1717 | "characterize the LANX Posterior Cervicothoracic Spinal Fixation system" |
| Mechanical performance per ASTM F1798 | "characterize the LANX Posterior Cervicothoracic Spinal Fixation system" |
| Comparable mechanical properties to predicate devices | "Mechanical testing demonstrated comparable mechanical properties to the predicate devices" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical tests. Mechanical testing typically involves a set number of device components or constructs rather than patient data.
- Data Provenance: Not applicable in the context of mechanical performance testing. This is not a study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for mechanical testing is established by adherence to specified test methods and measurable physical properties, not expert consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. Mechanical testing results are objective measurements against established standards, not subject to adjudication in the human-reader 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:
- No MRMC comparative effectiveness study was done. This device is a physical spinal implant, not a diagnostic AI device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is objective mechanical properties and structural integrity as measured against established ASTM standards (F1717 and F1798), and comparison to the mechanical properties of legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning device.
§ 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.