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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-6AI-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 Special 510(k) submission for the 4CIS® VANE Spine System, focusing on the addition of new screw sizes. The core of the submission revolves around demonstrating that these size additions do not introduce any new safety risks and therefore the device remains substantially equivalent to its predicate.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance metric with a specific threshold (e.g., accuracy > 90%). Instead, the performance demonstrated is based on mechanical testing to ensure the new screw sizes maintain equivalence in strength.

2. Sample Size Used for the Test Set and Data Provenance

The "test set" in this context refers to the physical samples of the device components (screws) that underwent mechanical testing.

• Sample size: Not explicitly stated. The document refers to "testing (static and dynamic compression, static torsion testing per ASTM F1717)" but does not specify the number of samples tested for each condition or screw size.
• Data provenance: The tests were conducted on the device components themselves (presumably new poly axial and poly reduction screw sizes). The country of origin for the device manufacturer is South Korea (Republic of Korea). The testing itself is implied to be laboratory-based mechanical testing, not retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to this submission. The "ground truth" for mechanical testing is established by the specified ASTM F1717 standards and the physical properties of the material and design, not by expert consensus.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data, not for objective mechanical testing against a standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This submission did not involve an MRMC study. These studies are relevant for evaluating the impact of AI or assisted technologies on human reader performance, which is not the subject of this 510(k). Biomechanical testing for spinal implants does not involve human readers in this manner.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical spinal implant system, not a software algorithm or AI. Therefore, standalone algorithm performance studies are not relevant.

7. Type of Ground Truth Used

The ground truth used for this submission is based on established engineering standards and biomechanical properties as defined by ASTM F1717 for static and dynamic compression and static torsion. The goal was to show that the new sizes conform to these standards and do not degrade the performance of the predicate device.

8. Sample Size for the Training Set

This is not applicable. The device is a physical implant, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for this type of device submission.

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