(83 days)
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System 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
- Trauma/Fracture/Dislocation .
- Atlanto-Axial Fracture with Instability .
- Occipito-Cervical Dislocation .
- Failed Previous Fusion .
- Tumor .
The use of occipital bone screws is limited to placement in the occiput only.
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 purpose of this 510(k) submission is to add modified rods, screws and hooks to the Lanx Posterior Cervicothoracic Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, plates, rods, 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, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient.
The predicate Lanx Posterior Cervicothoracic Spinal Fixation System is fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537 in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy components does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.
The provided text describes a 510(k) submission for a medical device, the Lanx Posterior Cervicothoracic Spinal Fixation System, seeking clearance to add modified components and demonstrate substantial equivalence to a predicate device. The information provided focuses on the mechanical testing conducted and does not contain details about acceptance criteria, clinical study design, or performance metrics typically associated with AI/software-as-a-medical-device (SaMD) evaluations.
Therefore, many of the requested categories (2-9) are not applicable or cannot be answered from the provided text.
Here's an analysis of what can be extracted:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Criterion: The modified Lanx Posterior Cervicothoracic Spinal Fixation System must demonstrate substantial equivalence to the predicate device in terms of mechanical properties. |
Specific Test Requirements (Implied):
- Static axial compression bending per ASTM F1717
- Dynamic axial compression bending per ASTM F1717
- Static torsion tests per ASTM F1717 | Performance: The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device in static axial compression bending, dynamic axial compression bending, and static torsion tests in accordance with ASTM F1717. |
Study that Proves Device Meets Acceptance Criteria:
A non-clinical performance study was conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System.
- Type of Study: Non-clinical (mechanical) performance testing.
- Tests Performed: Static and dynamic axial compression bending and static torsion tests in accordance with ASTM F1717.
- Comparison: The results of the modified system were compared to those of the predicate systems (Lanx PCFS K092656 and Solanas K052201).
- Conclusion: The study found that the modified device functioned as intended and the observed test results demonstrated substantial equivalence to the predicate device. This conclusion serves as the proof that the device meets the acceptance criteria of mechanical equivalence.
Information Not Applicable or Not Provided:
The following information is not present in the provided 510(k) summary, as it is primarily a mechanical device submission and not related to AI/SaMD or clinical trial performance in the way the questions are framed:
- Sample size used for the test set and the data provenance: Not applicable for a mechanical performance study. The test "set" would refer to the number of components or constructs tested, but this detail is not provided, nor is data provenance in the context of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is based on objective measurements from standardized tests.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 study was conducted, as this is not an AI-enabled device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance against ASTM standards.
- The sample size for the training set: Not applicable as this is not a learning algorithm.
- How the ground truth for the training set was established: Not applicable as this is not a learning algorithm.
§ 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.