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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 sacrabiliac 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 Polaris Spinal System to add new uniplanar screws fabricated from titanium.

Based on the provided text, the Polaris Spinal System is a medical device, and its acceptance criteria and the study proving it meets these criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly mention a "test set" in the context of clinical data for the uniplanar screws. Instead, the evaluation focuses on mechanical testing.

• Sample Size: Not specified for the mechanical tests, beyond the implication that multiple tests were performed per ASTM standards.
• Data Provenance: The mechanical testing was "conducted in accordance to ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model." This refers to laboratory-based mechanical testing, not human or animal study data.

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

This information is not applicable to this submission, as the evaluation was based on mechanical testing, not clinical expert review or diagnostic performance.

4. Adjudication Method for the Test Set

This is not applicable, as there was no test set involving human assessment or adjudication.

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

No MRMC comparative effectiveness study was mentioned. The submission is for a line extension of a spinal fixation system, focusing on mechanical equivalence.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical spinal implant system, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the mechanical testing was the specifications and performance characteristics set forth by the ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model, and the performance of predicate devices. The goal was to demonstrate substantial equivalence to these established standards and predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is a physical surgical implant, not an AI/ML algorithm that requires a training set.

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

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

Study Proving Device Meets Acceptance Criteria

The study that proves the device meets the acceptance criteria is mechanical testing performed in accordance with ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model.

The document states:
"Mechanical testing (conducted in accordance to ASTM 1717-04 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Vertebrectomy Model) included static compression bending, static torsion and dynamic compression bending fatigue. Based upon the mechanical testing, these screws are substantially equivalent for their intended use to other spinal systems currently on the market."

The "acceptance criteria" here are implicitly defined by achieving performance that is "substantially equivalent" to predicate devices and consistent with the established ASTM standards for the mechanical properties tested (static compression bending, static torsion, and dynamic compression bending fatigue). The study concluded that the new uniplanar screws met this "substantial equivalence" based on the mechanical test results.

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