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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, kyphosis, 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, kyphosis), 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.

This submission is a line extension to the EBI Helical Flange System to add new 5.5 and 6.35 Polaris components in order to build various types of spinal constructs. The new components include various types of bone screws, bone hooks, plugs, rods, connectors and accessories in stainless steel.

The provided document is a 510(k) summary for the Polaris Spinal System and does not contain information regarding acceptance criteria for a device's performance based on a study, nor does it describe such a study.

This document is a regulatory submission to the FDA for a medical device (a spinal fixation system). It focuses on demonstrating "substantial equivalence" to previously approved predicate devices, primarily through technological characteristics (material, design, sizing) and principles of operation, rather than detailed performance studies with specific acceptance criteria and outcome metrics for a novel device.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the document states:

• "Based upon the mechanical testing, the Polaris Spinal System is substantially equivalent for its intended use to other spinal systems currently on the market." (page 2)

This indicates that some "mechanical testing" was performed to support the claim of substantial equivalence, but it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of 510(k) submission generally relies on comparing a new device's design and materials to existing devices and often includes bench testing (mechanical testing) to show that the new device performs at least as well as the predicates in specific mechanical properties (e.g., strength, fatigue life), but these results are typically summarized as meeting "substantial equivalence" rather than being presented as detailed clinical or algorithm performance studies.

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