(105 days)
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.
| Acceptance Criteria (Quantitative - Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| Dynamic flexion-extension per ASTM F1798: (Specific load/displacement/cycles not provided) | Met or exceeded acceptance criteria |
| Torsional strength of screw/screwdriver interface: (Specific torque/failure limit not provided) | Met or exceeded acceptance criteria |
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)
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.