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The Southern Spine C Fuse™ Cervical Intervertebral Body Fusion System is intended for single level spinal fusion procedures in skeletally mature patients with degenerative disc disease ("DDD") of the cervical spine. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The C-Fuse device is to be implanted via an anterior approach at the C3 to C7 disk levels using autogenous bone graft and is to be combined with supplemental fixation. Patients should have had at least six weeks of non-operative treatment prior to treatment with the device.

The C.Fuse Cervical Intervertebral Body Fusion System is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an adjunct to spinal fixation. The device is trapezoidal in shape, with machined grooves on the superior and inferior surfaces, along with a hollow center core to accept autogenous bone graft. There are two materials used in the manufacture of the Southern Spine C-Fuse Cervical Intervertebral Body Fusion System devices which are the Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560. There is instrumentation for implantation and a sterilization trav for steam sterilization. The implants are non-sterile and single use. The instrumentation is non-sterile and reusable.

The provided text describes the C-Fuse™ Cervical Intervertebral Body Fusion System, a cervical interbody fusion device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria in a clinical study.

Therefore, the information you requested regarding acceptance criteria and a study proving device performance in the context of AI/machine learning is not applicable to this document. This device is a physical medical implant, and its performance is evaluated through material testing and mechanical standards.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance (Table): This document does not establish specific performance metrics (like accuracy, sensitivity, or specificity) that would be relevant for an AI/ML device. Instead, it refers to compliance with material and mechanical testing standards.
• Sample Size for Test Set and Data Provenance: This information is relevant for studies involving data analysis, typically in AI/ML. The C-Fuse system is a physical implant; its evaluation involves mechanical testing, which does not use "test sets" in the AI sense.
• Number of Experts and Qualifications: Experts might be involved in evaluating the design or clinical outcomes, but not in establishing ground truth for a "test set" as understood in AI/ML validation.
• Adjudication Method: Not applicable for mechanical and material testing.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is specific to diagnostic imaging or AI applications where human readers' performance is compared with and without AI assistance. This is not relevant to a physical spinal implant.
• Standalone Performance: While the device has standalone performance in terms of its mechanical properties, it's not "standalone" in the AI sense of an algorithm.
• Type of Ground Truth Used: For a physical implant, "ground truth" relates to its material specifications, mechanical integrity, and biological compatibility, not classifications derived from data.
• Sample Size for Training Set and How Ground Truth was Established for Training: These concepts are entirely specific to AI/ML model development and are not relevant to the regulatory submission for a physical medical device.

Instead, the document details the following studies and compliance:

• Study Type: Mechanical and material testing to demonstrate substantial equivalence to predicate devices.
• Acceptance Criteria/Standards Met:
  • ASTM F2077 (Standard Test Methods for Intervertebral Body Fusion Devices)
  • ASTM F2267 (Standard Test Method for Measuring Load-Displacement Properties of Spine Implants in a Corpectomy Model)
  • Compliance with 2007 "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" which identifies the above standards.
• Tests Performed:
  • Static axial testing
  • Static compression shear testing
  • Dynamic axial testing
  • Dynamic compression shear testing
  • Static torsion testing
  • Dynamic torsion testing
  • Static subsidence testing
  • Static expulsion testing
• Materials Tested: Zeniva® ZA-500 (PEEK) under ASTM F2026 and Tantalum Wire Type R05400 under ASTM F560.
• Conclusion: "Testing results support the determination of substantial equivalence for the C-Fuse Cervical Intervertebral Body Fusion System against the predicate devices." This means the device met the mechanical and material performance requirements to be considered sufficiently similar to existing approved devices, implying it passed the tests according to the established standards and guidance.

In summary, this document is for a physical medical device, not an AI/ML-driven device, so the requested information about acceptance criteria and studies for AI/ML is not present.

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