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ARTFX SPINAL FIXATION SYSTEM is intended for use in the noncervical spine. When used as an anterior anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the ARTFX SPINAL FIXATION SYSTEM is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

-Degenerative dise disease (DDD) (defined as back pain of discogenic origin with degeneration of the dise confirmed by history and radiographic studies): .

-Spondylolisthesis;

• Trauma (i.e. fi acture or dislocation);
  -Spinal stenosis:

• -Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)

• Tumor:

• -Pseudoarthrosis; and Failed previous fusion

The Proposed system is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, monoaxial pedicle screws, cannulated screws , rods (Straight and pre-bent) , connectors , hooks and setscrews. The Artfx Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

ARTFX SPINAL FIXATION SYSTEM is supplied non-sterile, single use and fabricated from titanium alloy (Ti6Al4V-ELI) that conforms to ASTM F136.

The provided text describes the 510(k) premarket notification for the ArtFX Spinal Fixation System. It details the device's design, materials, indications for use, and performance testing relative to predicate devices. However, this document does not contain any information about an AI/ML-driven device, nor does it present any studies that involve acceptance criteria, performance metrics, ground truth establishment, or human reader studies typically associated with AI/ML medical devices.

The document primarily focuses on demonstrating substantial equivalence for a physical medical device (spinal fixation system) based on material properties, mechanical testing (ASTM F1717, F1798), and similarity in design and intended use to existing predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them for an AI/ML context using the provided text. The information required for your request (AI/ML performance, ground truth, sample sizes for AI training/testing, expert review, human-in-the-loop studies) is not present in this FDA clearance letter for a spinal implant.

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