(72 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 (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.
Materials: The devices are manufactured from Ti6AI4V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization of the posterior cervical and thoracic spine.
The provided text is a 510(k) summary for the Caspian Spinal System, a medical device. It focuses on demonstrating substantial equivalence to previously marketed devices based on mechanical testing and design comparisons, rather than clinical efficacy studies with acceptance criteria, human readers, or ground truth.
Therefore, most of the requested information cannot be extracted from this document as it does not describe a study involving an AI device or a device whose performance is measured against acceptance criteria in a clinical context.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria in the context of clinical performance metrics. | "The Caspian Spinal System performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717." |
| "The design features and sizing of the components were also compared and the Caspian Spinal System was found to be substantially the same as these systems." | |
| "There are no significant differences between the Caspian Spinal System and other systems currently being marketed which would adversely affect the use of the product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study described is mechanical testing, not a clinical study with a test set of data.
3. 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. There was no ground truth based on expert review for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication for a test set was mentioned.
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
Not applicable. This document describes a spinal implant, not an AI device or a device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical spinal fixation system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The 'ground truth' for this mechanical testing would be the measured physical properties and performance of the device and its predicates, compared to established ASTM standards.
8. The sample size for the training set
Not applicable. There is no training set for an AI algorithm mentioned in this document.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI algorithm mentioned in this document.
§ 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.