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The Savannah Technologies Spinal 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, the Savannah Technologies Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

The Savannah Technologies Spinal System has been developed with the objective of providing the surgeon with an adaptable fixation system in order to carry out dorsal stabilization of the spine simply, quickly and effectively.

The system consists of a variety of color coded top loading pedicle screws. The pedicle screws are available in various lengths and diameters. The screw is connected to the rod via a rod connector. The rods are available in multiple lengths. The system has cross linkage assemblies to supply torsional stability to the construct.

Materials:
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and ISO 5832-3.

Function:
The Savannah Technologies Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments until fusion takes place.

The Savannah Technologies Spinal System is a spinal fixation system that was reviewed under K113755.

1. Acceptance Criteria and Device Performance

The acceptance criteria for the Savannah Technologies Spinal System were based on equivalency to predicate devices through non-clinical mechanical testing, specifically static and dynamic compression, and static torsion. Since no clinical studies were performed, there are no reported device performances from clinical trials to present in this table.

2. Sample Size and Data Provenance

Given that no clinical studies were performed, there is no information regarding sample size for a test set or data provenance from patient studies. The evaluation relied solely on non-clinical mechanical testing.

3. Number of Experts and Qualifications for Ground Truth

No clinical studies were performed, therefore, no experts were used to establish ground truth for a clinical test set. The evaluation was based on engineering and materials testing.

4. Adjudication Method

As no clinical studies were performed and no human interpretation of data was required for the submission regarding patient outcomes, there was no adjudication method specified.

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

No MRMC comparative effectiveness study was done, as no clinical studies involving human readers or AI assistance were conducted.

6. Standalone Performance

No standalone performance data for an algorithm (i.e., AI without human-in-the-loop) was provided, as this device is a physical pedicle screw system, not an AI/software device.

7. Type of Ground Truth Used

The ground truth used for proving device performance was based on mechanical testing standards (ASTM F1717) and comparison to the mechanical properties of legally marketed predicate devices. No pathology or outcomes data from human subjects were used.

8. Sample Size for the Training Set

Not applicable. The device is a physical medical implant, not an AI/machine learning model, so there is no "training set" in the context of data used for algorithm development.

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

Not applicable. As noted above, there is no training set for this device. The "ground truth" for the non-clinical testing was established by following recognized ASTM standards for mechanical testing of spinal fixation devices.

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