(168 days)
The Caspian Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
- Atlantoaxial fracture with instability
- Occipitocervical dislocation
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
The Caspian Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, rod connectors, and occipital components.
Materials: The devices are manufactured from Ti6Al4V (ASTM F1472), Ti6Al4V Eli (ASTM F136), and CP Titanium (ASTM F67).
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior cervical and thoracic spine.
The Caspian Spinal System is a medical device intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction. The device's performance was evaluated through mechanical testing, with the acceptance criterion being that it performed "equally to or better than" predicate devices.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance in static compression | Performed equally to or better than predicate devices |
| Performance in static torsion | Performed equally to or better than predicate devices |
| Performance in dynamic compression | Performed equally to or better than predicate devices |
| Design features and sizing of components | Substantially the same as predicate devices |
Study Details
- Sample Size for Test Set: This information is not explicitly provided. The document states that the system was "mechanically tested," implying a set of samples were used for these tests, but the specific number is not given.
- Data Provenance: Not applicable. The study involved mechanical testing of the device itself, not human data.
- Number of Experts Used to Establish Ground Truth: Not applicable. Mechanical testing relies on established engineering standards (ASTM F2706) rather than expert consensus on individual cases.
- Qualifications of Experts: Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is relevant for diagnostic or image-interpretation devices involving human readers, which is not the case for a spinal fixation system.
- Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.
- Type of Ground Truth Used: The "ground truth" for this device's performance is defined by the established mechanical testing standards, specifically ASTM F2706, and the performance of legally marketed predicate devices. The system was deemed acceptable if its mechanical performance met or exceeded that of these established devices.
- Sample Size for Training Set: Not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
§ 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.