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LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, LineSider™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, LineSider™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft and/or allograff. Pediatric pedicle screw fixation is limited to a posterior approach.

The LineSider™ Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.

The provided text describes the LineSider™ Spinal System, a thoracolumbosacral pedicle screw system, and its FDA 510(k) clearance. However, it does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML device performance.

The document is a traditional 510(k) clearance letter for a physical medical device (spinal system), which focuses on mechanical performance and substantial equivalence to predicate devices, rather than AI/ML algorithm performance.

Therefore, I cannot extract the requested information regarding AI/ML device performance, as it is not present in the provided text.

Here's why and what information is available:

• Acceptance Criteria & Reported Device Performance (AI/ML): Not applicable. The document discusses mechanical testing criteria for a physical spinal implant, such as static axial compression, static torsion, and dynamic axial compression bending fatigue. It states: "The results of this non-clinical testing show that the strength of the LineSider™ Spinal System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." No specific quantitative acceptance criteria or reported performance metrics for an AI/ML component are provided because there isn't one.
• Sample size and data provenance (AI/ML): Not applicable.
• Number of experts and qualifications (AI/ML): Not applicable.
• Adjudication method (AI/ML): Not applicable.
• MRMC comparative effectiveness study (AI/ML): Not applicable.
• Standalone (algorithm only) performance (AI/ML): Not applicable.
• Type of ground truth (AI/ML): Not applicable.
• Training set sample size (AI/ML): Not applicable.
• How ground truth for training set was established (AI/ML): Not applicable.

Summary of what is available in the document regarding traditional device testing:

• Device Name: LineSider™ Spinal System
• Regulatory Class: Class II
• Product Code: NKB, KWP
• Predicate Devices: K170126 (NuVasive® Reline® 4.5-5.0 System) and K041449 (Synergy VLS)
• Performance Tests Conducted:
  • Static axial compression bending per ASTM F1717-18
  • Static torsion per ASTM F1717-18
  • Dynamic axial compression bending fatigue per ASTM F1717-18
• Conclusion: "The overall technology characteristics and mechanical performance data lead to the conclusion that the LineSider™ Spinal System is substantially equivalent to the predicate devices."

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