(182 days)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks, rods, and cross connectors are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, cross connectors and locking breakaways.
Here's a breakdown of the acceptance criteria and study information for the SOLSTICE OCT System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Must demonstrate substantial equivalency to predicate devices in terms of mechanical stability and robustness for spinal fixation. Specific criteria were for dynamic testing in accordance with ASTM F1717. | Dynamic testing in accordance with ASTM F1717 was presented to demonstrate the substantial equivalency of the SOLSTICE OCT System. |
| Material Composition: Must be manufactured from medical grade titanium alloy (6AL-4V-ELI). | The SOLSTICE OCT System is manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6Al-4V-ELI) implant grade titanium alloy. |
| Indications for Use: Must align with the intended use of predicate devices for promotion of spinal fusion in the cervical spine and occipito-cervico-thoracic junction. | The indication/intended use of the modified device as described in its labeling has not changed from predicate devices. The system is intended for degenerative disc disease, spondylolisthesis, spinal stenosis, fracture/dislocation, Atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance data refers to a dynamic testing study, which typically involves mechanical testing rigs rather than human or animal subjects that would generate "data" in the conventional sense of clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study presented is a dynamic mechanical test (ASTM F1717) and not a study that requires human interpretation or expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the study presented is a dynamic mechanical test (ASTM F1717) and does not involve subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information focuses on mechanical performance testing and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This is not applicable. The device is a physical spinal fixation system, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for this device's performance is established by technical specifications and standards, specifically:
- ASTM F1717: Standard mechanical test method for spinal implant constructs. The "ground truth" is that the device must meet or exceed the performance parameters defined by this standard, or demonstrate comparable performance to predicate devices tested under the same standard.
- ASTM F136: Standard specification for implantable titanium alloy. The "ground truth" is the material composition meeting this standard.
8. Sample Size for the Training Set
This is not applicable as the device is a physical spinal implant system and does not involve AI or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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.