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The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization 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 for use with autograft. The Polaris Spinal System is indicated for the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, Scheuerman's disease, and/or lordosis,), tumor, stenosis, pseudarthrosis, or failed previous fusion.

The Ballista and Cypher MIS instruments are intended to be used with Ballista/Cypher MIS/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.

For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolisthesis/spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.

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 dominoes in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine 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.

The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. Various instruments are also available for use by the surgeon to facilitate implantation of the device. The purpose of this Premarket Notification is to add modified Ø4.75mm multi-axial screws.

The provided document describes the clearance of the Biomet Spine Polaris Spinal System (K151974) by the FDA. It is a 510(k) premarket notification, which means the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information typically found in a study proving acceptance criteria for a novel device (like specific performance metrics, sample sizes for test sets, expert consensus for ground truth, etc.) is generally not present in this type of submission.

Instead, the submission focuses on demonstrating that the new device (modified Ø4.75mm multi-axial screws for the Polaris Spinal System) is as safe and effective as its predicate device (Polaris Spinal System – K133746). This is primarily achieved through mechanical testing to verify that the modified components meet established standards for spinal implants.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Guidance and Standards): The device must meet the mechanical test requirements based on the worst-case construct testing according to "FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s" dated May 3, 2004, and ASTM standards. This implies demonstrating sufficient strength, durability, and resistance to wear for safe use as a spinal implant.

Reported Device Performance:

Note: The document explicitly states: "The mechanical testing verifies that the subject components are substantially equivalent to other spinal systems currently on the market for its intended use and has met all mechanical test requirements based on the worst-case construct testing." Specific numerical acceptance values or pass/fail thresholds for each test are not detailed in this summary, as is common for 510(k) summaries where the focus is on meeting recognized standards.

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

• Sample Size for Test Set: Not explicitly stated in the 510(k) summary. Mechanical testing is typically conducted on a representative sample of devices, but the exact number of units tested per configuration is not disclosed.
• Data Provenance: The mechanical testing was conducted by the applicant, Biomet Spine, to demonstrate compliance with FDA guidance and ASTM standards. This data is part of their submission to the FDA. It is not patient or clinical data, but rather engineering test data.

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

This question is not applicable to this type of submission. "Ground truth" in the context of mechanical testing refers to the physical properties and performance of the device under specific loads, as measured by standardized testing procedures. It does not involve human expert consensus in the way clinical diagnostic or image interpretation studies do. The "truth" is established by the test setup and measurement equipment's accuracy and precision, adhering to established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or image interpretation studies where there might be disagreement among human evaluators. Mechanical testing results are objective measurements derived from physical tests following defined protocols, not subject to human subjective interpretation requiring adjudication.

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 device is a mechanical spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to its evaluation.

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

Not applicable. This device is a mechanical spinal implant, not an algorithm or software. Its performance is evaluated through physical mechanical testing.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical testing is defined by the objective performance parameters as measured against the specified ASTM standards and FDA guidance. These standards dictate acceptable loads, deformation, and fatigue life for spinal implants. The "truth" is whether the device physically withstands these tests as required by the standards, not a diagnostic or pathological determination.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of device development or evaluation.

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

Not applicable, as there is no training set for a mechanical spinal implant.

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