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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 (T1-73) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The 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 Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136 and cobalt chrome alloy per ASTM F1537. 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 Lanx Posterior Cervicothoracic Spinal Fixation System is a medical device for spinal fixation.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The study was non-clinical (mechanical testing), so concepts like "test set" in the context of patient data or "data provenance" (country of origin, retrospective/prospective) are not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study was non-clinical (mechanical testing). Ground truth in this context would refer to established engineering standards (ASTM F1717), not expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the study was non-clinical mechanical testing, not a clinical study involving human assessment or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not performed. The study was non-clinical mechanical testing comparing the modified device to a predicate device.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense of a laboratory-based mechanical test of the device itself. The "algorithm only" aspect of the question is not relevant here as this is a physical medical device. The study characterized the modified Lanx Posterior Cervicothoracic Spinal Fixation System's mechanical performance.

7. Type of Ground Truth Used

The "ground truth" for this non-clinical study was the established mechanical testing standard, ASTM F1717. The performance of the modified device was compared against the performance of the predicate device under these standardized conditions to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable as there was no "training set" in the context of an algorithm or machine learning. The study involved mechanical testing of the physical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

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