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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 Accu Vision 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 the combination of the multiaxial and fixed titanium screws (Ø4.0mm) with the CoCr rods in the system and to update the indications for use for the system.

This 510(k) submission describes a line extension for the Polaris Spinal System and does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of AI/algorithm performance.

The document discusses:

• Device Description: The Polaris Spinal System, a non-cervical spinal fixation device, and its indications for use.
• Line Extension: The submission is for adding a combination of multiaxial and fixed titanium screws (Ø4.0mm) with CoCr rods to the existing Polaris Spinal System and updating its indications for use.
• Performance Data: An "engineering analysis" was conducted to determine if a new worst-case construct was created by the new component combination. It concluded that no new worst-case construct was created, and therefore, "additional testing was not required to demonstrate substantial equivalence."
• Substantial Equivalence: The key determination is that the new components are substantially equivalent to previously cleared components within the Polaris Spinal System (K0902033, K091067, and K100220).

Therefore, I cannot provide the requested information regarding acceptance criteria and studies demonstrating device performance, as this document is a 510(k) for a hardware modification and marketing clearance, not a study evaluating an AI or algorithm's performance. The "performance data" mentioned is an engineering analysis to confirm that new mechanical testing was not needed due to the substantial equivalence of the new components to existing ones.

To answer your specific questions in the context of an AI/algorithm device, I would need a different type of document that describes a clinical or technical study designed to evaluate the performance of such a device.

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