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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 fusion for the 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, LineSider™ is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft. 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 LineSider™ Spinal System subject to this 510(k) adds non-modular screws to the line offered under K190360.

This document is a 510(k) summary for the LineSider™ Spinal System, which is a thoracolumbosacral pedicle screw system. It describes an expansion of an already cleared device to include non-modular screws.

Based on the provided text, the device itself is a spinal implant system, not an AI or imaging device with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested categories for AI/imaging device studies (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies) are not applicable.

The "acceptance criteria" and "device performance" instead refer to mechanical strength and substantial equivalence to predicate devices, rather than diagnostic accuracy.

Here's a breakdown of the applicable information:

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

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

• Test Set Sample Size: Not applicable. This refers to mechanical testing of physical parts, not a data-driven test set for an algorithm. The testing involves physical samples of the spinal system components.
• Data Provenance: Not applicable in the context of clinical or image data. The data provenance is from laboratory mechanical testing performed by Empirical Testing Corp. (Colorado Springs, Colorado).

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)

• Not applicable. Ground truth in this context refers to the physical properties of the spinal implants, which are assessed through standardized mechanical testing according to ASTM F1717. The "ground truth" is adherence to established engineering standards rather than expert clinical consensus.

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

• Not applicable. Adjudication methods are typically for reconciling discrepancies in human expert evaluations. Mechanical testing results are objective measurements.

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

• Not applicable. This is a medical device (spinal implant) clearance, not an AI diagnostic or assistance tool.

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

• Not applicable. This is for a physical medical device, not an algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance is compliance with pre-defined mechanical performance standards (ASTM F1717), which ensure the device's structural integrity and equivalence to predicate devices under specified loads and conditions.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of mechanical testing for a spinal implant.

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

• Not applicable. There is no "training set" for this type of device submission.

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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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