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The Spider® Cervical Plating System is intended for anterior fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following: degenerative disc disease (as identified by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal tumors, deformity (e.g., kyphosis, lordosis, scoliosis), pseudarthrosis, and/or failed previous fusion.

The Spider® Cervical Plating System consists of titanium alloy (Ti 6Al 4V ELI) anterior cervical plates and bone screws, allowing for fixation between one and four intervertebral segments. The plates attach to the anterior portion of the vertebral body of the cervical spine, levels C2 to C7. The titanium alloy conforms with ASTM F136, Standard Specification Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) alloy for Surgical Implant Applications (UNS R56401).

The system does not contain software/firmware.

The provided text is a 510(k) summary for the Spider® Cervical Plating System. This document describes a medical device, specifically an implant for spinal fixation, and compares it to previously cleared predicate devices to demonstrate substantial equivalence.

The content focuses on mechanical and material properties of the device (e.g., titanium alloy, screw lengths, pullout testing) to support its safety and effectiveness for its intended surgical purpose. It does not contain information related to AI/ML or software-based medical devices, nor does it describe clinical studies for such devices.

Therefore, I cannot extract the information requested about acceptance criteria and a study proving device performance in the context of AI/ML devices, including:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical test results for a physical implant, not performance metrics like sensitivity, specificity, or AUC for an AI/ML algorithm.
2. Sample sizes used for the test set and the data provenance: Not applicable, as there's no test set of image data or patient data referenced in the context of AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device would involve expert annotations or clinical outcomes, which are not described here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. The "ground truth" for this device's performance would be engineering specifications and biomechanical test results.
8. The sample size for the training set: Not applicable, as there is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML training set.

The document states: "The system does not contain software/firmware." This explicitly confirms that the device described is a purely mechanical implant and not a software/AI/ML device.

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