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The Coligne GII Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion. The GII Spinal Fixation System is intended for use in the non-cervical posterior spine, in skeletally-mature patients, as an adjunct to fusion using autograft and/or allograft, the GII Spinal Fixation System is intended for use or more of the following; (1) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) spinal stenosis, (6) deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), (7) spinal tumor, and/or (8) failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Coligne GII Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis and fracture caused by tumor and/or trauma.

This system is intended to be used with autograft. Pediatic pedicle screw fixation is limited to a posterior approach.

The GII Spinal Fixation System is a top loading polyaxial pedicle screw, which, when used with rods and crosslinks, results in a multiple component, posterior system. All the components are available in a variety of sizes to match the patient's anatomy more closely.

This document outlines the FDA's 510(k) premarket notification clearance for the Coligne GII Spinal Fixation System. The focus of the 510(k) submission is to add flexStaas pedicle screws to the existing system.

Based on the provided text, the device in question is a Spinal Fixation System, and the "study" referred to is a non-clinical test summary to demonstrate that the new component (flexStaas pedicle screws) meets performance criteria compared to predicate devices. There were no clinical studies performed.

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

Acceptance Criteria and Reported Device Performance

The document states that the flexStaas pedicle screws of the GII Spinal Fixation System met or exceeded acceptance criteria for two specific non-clinical tests. However, the specific quantitative acceptance criteria values are not explicitly stated in this document. Only the types of tests and the outcome ("met or exceeded") are provided.

Note: The document only provides a qualitative summary of the non-clinical test results. The actual quantitative acceptance criteria and the measured performance values would be detailed in the full test reports, which are not included in this FDA clearance letter.

Study Information (Non-Clinical)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for the non-clinical tests. The number of samples for dynamic flexion-extension and torsional strength tests is typically specified in the test protocols, but not in this summary.
   • Data Provenance: The tests were performed "in support of this Special 510(k)". It is implied that these tests were conducted by the manufacturer, Coligne AG, or a contracted testing facility. The country of origin of the data is not specified beyond the company being located in Zurich, Switzerland. The tests are prospective in the sense that they were performed to support the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This was a non-clinical, mechanical testing study, not a study involving expert review of medical images or patient outcomes. The "ground truth" for mechanical tests is defined by established engineering standards (ASTM F1798) and material properties.

3. Adjudication method for the test set:

   • Not Applicable. This was a non-clinical, mechanical testing study. Adjudication methods like 2+1 or 3+1 are used for human reader studies or when establishing ground truth from multiple expert opinions.

4. 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:

   • No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted. This device is a mechanical implant, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a mechanical device, not an algorithm. Standalone performance refers to the accuracy or performance of an AI algorithm independent of human intervention.

6. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" is based on established engineering standards (specifically ASTM F1798 for dynamic testing) and material property specifications (e.g., strength requirements for medical implants). It's not a medical "ground truth" like pathology or clinical outcomes.

7. The sample size for the training set:

   • Not Applicable. The document describes a mechanical device requiring non-clinical testing, not a machine learning model that would have a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. As no training set was involved (this is a mechanical device), no ground truth for a training set needed to be established.

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