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The 5.5 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 5.5 Polaris Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The 5.5 Polaris Percutaneous Instruments when used with the 5.5 Polaris Spinal System 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), turnor, 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 5.5 Polaris Mini-Open Instruments, when used with the 5.5 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, 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 5.5 Helical Flange Spinal System to add new Polaris components, which may be used with the other 5.5mm components in order to build various types of spinal constructs.

This document describes a 510(k) premarket notification for a medical device, the 5.5 Polaris Spinal System. The provided text, however, focuses on the administrative details, indications for use, and a declaration of substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria and performance data.

Therefore, based solely on the provided text, I cannot extract concrete information for most of the requested categories. The document asserts that the device is "substantially equivalent" to predicate devices, implying that it meets the same implicit performance standards, but it does not present those standards or device performance in a quantifiable manner as would be found in a detailed study report.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The 510(k) summary focuses on establishing substantial equivalence rather than presenting a standalone performance study against pre-defined acceptance criteria. It mentions "mechanical testing" generally but does not detail the specific tests, their acceptance criteria, or the numerical results.

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

• Sample Size: Not specified. The document refers to "mechanical testing" but does not provide details on the number of devices or components tested.
• Data Provenance: Not specified. The country of origin of the data (if any physical testing was conducted) and whether it was retrospective or prospective is not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The study appears to be mechanical testing of the device itself, not clinical data requiring expert review for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable and not provided. This would typically be relevant for clinical studies involving expert interpretation, not mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not done. This type of study is relevant for imaging or diagnostic devices where human readers interpret results, often with and without AI assistance. The 5.5 Polaris Spinal System is a physical spinal fixation device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This concept is not applicable as the device is a physical spinal implant system, not a software algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied in AI/diagnostic studies is not relevant here. For a physical device like a spinal system, performance is assessed through mechanical testing against engineering specifications, and "effectiveness" is primarily linked to its mechanical properties and safety when implanted. The document implies that "mechanical testing" was performed to demonstrate performance. The "ground truth" would be the engineering standards and established performance ranges for similar predicate devices.

8. Sample Size for the Training Set

No training set information is provided. This is not a machine learning or AI-driven device that would typically involve training sets.

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

Not applicable, as there is no training set for this device type.

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