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The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions:

· Degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

• · Trauma (i.e., fracture or dislocation)
• · Spondylolisthesis

• Tumor

The VIATM Spinous Process Fixation System is not intended for stand-alone use.

The VIA™ Spinous Process Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion, and it is not intended for stand-alone use. When the VIA™ Spinous Process Fixation System is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1). The VIA Spinous Process Fixation System consists of a three-piece design. The larger male piece (plate) is comprised of a plate with teeth and a spacer in the middle. The two other additional pieces are plates (with teeth) that contain the female ends of the connection with the male spacer. The two female plates engage with the larger plate independently to accommodate variations in the spinal anatomy. The components are locked together with a set screw after assembly. The spinous process contact areas (with the teeth sections) on both the male and female plates do not vary in size. The central spacer on the male plate varies in height (cephalo-caudad), thus providing the different sizes of the device. All components are composed of titanium alloy (Ti-6A1-4V-ELI ASTM F136). Associated accessories include surgical instruments to facilitate implantation.

This document is a 510(k) premarket notification for the VIA™ Spinous Process Fixation System, a medical device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device. Instead, it describes a medical device, its intended use, and performance data from engineering verification tests.

Therefore, I cannot provide the requested table and information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are concepts relevant to the evaluation of AI/ML software.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Engineering Verification Tests:
  • Insertion Testing
  • Grip Strength Testing (using a modified ASTM F543-13 setup)
  • Dynamic Compression Bending (per ASTM F1717-13)

The document states that "The results met applicable acceptance criteria and verified the design features," but it does not specify what those acceptance criteria were, nor does it provide detailed study protocols, results, or statistical analyses that would be present in a study report for an AI/ML device.

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