(45 days)
When intended for stabilization as an adjunct to fusion of the cervical spine and occipito-cervicothoracic junction (occiput -T3), the Nextgen Altius OCT System is intended for use with allograft or autograft and indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); pseudoarthrosis; spinal stenosis; trauma, (i.e., fracture or dislocation); atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
The occipital bone screws are limited to occipital fixation only.
The use of pedicle screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Nextgen Altius OCT System can also be linked to the Biomet Polaris Systems via transitional rods or using Altius Rod Connectors or Polaris Dominoes. Please refer to the individual system's package insert for a list of indications for use for each system.
The Nextgen Altius OCT System is an occipito-cervico-thoracic spinal fixation system. The titanium alloy (Ti-6Al-4V) components in the system includes screws, locking plugs, various types and styles of rods, hooks, lateral connectors, set screws, occipital plates, rod connectors/dominos and various cross connectors. The system also includes CoCr rods fabricated from Co-28Cr-6Mo alloy. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with plugs. Cross connectors can be added to the construct for additional stability. This submission is a line extension to Nextgen Altius OCT System to add alternate styles of occipital plates, occipital screws and occipital locking plugs to the system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static compression bending requirements (ASTM F2706) | Met |
| Static torsion fatigue requirements (ASTM F2706) | Met |
| Compression bending fatigue requirements (ASTM F2706) | Met |
| Interconnection fatigue test of plate and rod assembly | Met |
| Substantial equivalence with predicate devices (intended use, indications, technological characteristics, operational principles, safety, efficacy) | Demonstrated substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The study does not explicitly mention a "test set" in the context of clinical data or human evaluation. The performance data presented are based on mechanical testing of the device components.
- Sample Size for Mechanical Testing: Not explicitly stated as a numerical count of individual components. The testing was conducted on "worst-case construct testing" to represent the system.
- Data Provenance: Not applicable in the context of human data. The data originates from laboratory mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. The "ground truth" for this device's performance is established through adherence to recognized mechanical testing standards (FDA Guidance and ASTM F2706) and comparison to predicate devices, rather than expert interpretation of clinical data.
4. Adjudication Method for the Test Set
Not applicable. This was a mechanical engineering study, not a clinical study involving human assessment and adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes mechanical testing for a spinal fixation system, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Mechanical Testing Standards: Adherence to established industry standards like ASTM F2706 for various force and fatigue tests, as well as FDA's Guidance for Spinal System 510(k)s.
- Predicate Device Performance: Comparison to the known performance and safety profiles of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning model, no ground truth needed to be established in that context.
§ 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.