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The 4CIS® VANE Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the 4CIS® VANE Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

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 510(k) submission for the "4CIS® VANE Spine System," a pedicle screw spinal fixation system. It details the device's description, indications for use, and a statement on performance data.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based only on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Mechanical testing" but does not specify a sample size or data provenance (country of origin, retrospective/prospective). It refers to "APPENDIX 10" for details, which is not provided in the input.

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)

This information is not applicable or provided. The "ground truth" for this device's performance appears to be based on adherence to a standard (ASTM F1717) for mechanical properties, not expert clinical assessment of images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or provided. The performance evaluation is based on mechanical testing against a standard, not on subjective assessment requiring adjudication.

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

No MRMC comparative effectiveness study was done. This device is a medical implant (pedicle screw system), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable or provided. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" used for this device's performance is adherence to the mechanical testing standards outlined in ASTM F1717, which implies objective physical and material properties.

8. The sample size for the training set

This information is not applicable or provided. This is a hardware device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable or provided. As above, this is a hardware device, not a machine learning model.

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