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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 anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft. 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, and lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

The Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista cannulated screws and percutaneous rods. are indicated 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, and lordosis), tumor. stenosis, pseudarthrosis, and 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.

The AccuVision Instruments, when used with the Polaris Spinal System implants are indicated to provide the surgeon with a minimally invasive 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 lordosis), tumor, stenosis, pseudarthrosis, and 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.

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 the Polaris Spinal System to add new stainless steel dominoes and washers to the system.

This 510(k) summary describes a line extension to the Polaris Spinal System, specifically adding new stainless steel dominoes and washers. The submission focuses on demonstrating substantial equivalence to existing predicate devices through mechanical testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Transverse Rotation (per ASTM 1798-97, reapproved 2003)
• Static Axial Slip (per ASTM 1798-97, reapproved 2003)
• Dynamic Axial Compression Bending-Fatigue (per ASTM 1717-04).
  The study verifies that the subject device is substantially equivalent to other spinal systems currently on the market and has met all mechanical test requirements based on the worst-case construct testing. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (number of devices/components tested) for each mechanical test. It refers to "worst-case construct testing" without quantifying the number of constructs or replicates.

Data provenance is not specified beyond indicating that the testing was performed, implying it was conducted by the applicant or a contracted lab. The country of origin is not mentioned, and the testing is prospective as it was performed for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for this type of device (spinal implants) is established through adherence to recognized international and national standards for mechanical testing, not expert interpretation of derived data. The "experts" are the engineers and technicians performing the tests according to the specified ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against established criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or imaging devices where human interpretation plays a role. This submission pertains to a mechanical medical device, and its evaluation relies on physical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established mechanical engineering standards, specifically ASTM 1798-97 (reapproved 2003) for static testing and ASTM 1717-04 for dynamic fatigue testing. These standards define the test methodologies and acceptance criteria for spinal systems.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this mechanical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no training set. The "ground truth" for showing safety and effectiveness in this context relies on meeting the performance specifications of the referenced ASTM standards, which are developed and validated by experts in materials science and biomechanics.

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