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The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista instruments are intended to be used with Ballista/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft.

The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

This submission is a line extension to Polaris Spinal System to add longer Ballista rods to the system.

The provided document is a 510(k) summary for a medical device (Polaris Spinal System), not a study report detailing acceptance criteria and performance of an AI/ML powered device. Therefore, much of the requested information is not applicable.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria or reported device performance in the manner typically found for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of device components based on an engineering analysis and validation testing.

2. Sample size used for the test set and the data provenance:

• Sample size: Not explicitly stated as a numerical sample size. The "cadaver" testing for validation implies a very small sample, but no number is given. The engineering analysis is not based on a "test set" in the sense of patient data.
• Data provenance: The cadaver validation testing would be considered prospective, as it was conducted specifically for this submission. The engineering analysis is theoretical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The assessment primarily relied on engineering analysis and cadaver testing, not on expert interpretation of medical images or data from a "test set." The "ground truth" here is the physical performance and safety of the device components, validated by engineering principles and practical demonstration, rather than expert consensus on a diagnosis.

4. Adjudication method for the test set:

Not applicable. There was no "test set" requiring adjudication by multiple experts in the context of diagnostic interpretation.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Engineering analysis: Based on established biomechanical principles and design specifications.
• Cadaver validation: Direct observation of the device's ability to be contoured and implanted.
• Substantial equivalence: Comparison to predicate devices with established safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set in the typical machine learning sense.

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

Not applicable. There is no training set.

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