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510(k) Data Aggregation
(226 days)
The 4CIS VANE Spine System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumour, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
The 4CIS® VANE Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) linking mechanism. The 4CIS® VANE Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. 4CIS® VANE Spine System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136. Various sizes of these implants are available. Specialized instruments are available for the application and removal of the 4CIS® VANE Spine System.
The provided text describes a spinal fixation system, not an AI/ML powered device, thus the acceptance criteria and study details relevant to AI/ML performance metrics are not available in this document.
The document discusses the substantial equivalence of the 4CIS® VANE Spine System to predicate devices based on mechanical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional testing (e.g., static and dynamic compression, static torsion) | Demonstrated comparable mechanical & functional properties to predicate devices (Optima K031585; 4CIS Vane Spine Systems cleared earlier under K060702 & K081145) |
| Compliance with ASTM F1717 | Demonstrated equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The study involved mechanical testing of the device, not a test set of data for an AI/ML algorithm.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Ground truth for AI/ML is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and measurements.
4. Adjudication Method:
Not applicable. Mechanical testing does not involve adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI/ML device.
6. Standalone Performance Study:
The "Performance Data" section indicates that "Mechanical testing... was conducted in accordance with ASTM F1717" to demonstrate equivalence to predicate devices. This represents a standalone evaluation of the device's mechanical properties against established standards and comparisons to existing devices.
7. Type of Ground Truth Used:
The ground truth for this device's performance is based on established engineering standards (ASTM F1717) and the mechanical properties of legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/ML device.
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