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This system is indicated for intervertebral fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with the autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Cervical Interbody Fusion System consists of instruments and VESTAKEEP PEEK (per ASTM F2026) and tantalum (per ASTM F560) implants which are designed for implantation via an anterior cervical approach. The Cervical Interbody Fusion System is comprised of various sizes to accommodate individual patient anatomy. The implants are single use and the system is provided non-sterile.

I am sorry, but the provided text describes a Cervical Interbody Fusion System, which is a medical device used for spinal fusion. The text details its regulatory classification, indications for use, materials, and non-clinical performance testing (e.g., static and dynamic axial compression, subsidence, expulsion).

The text does not contain any information about an AI-powered diagnostic device or a study involving human readers, ground truth establishment by experts, or any data provenance related to AI model testing. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI device, as the provided document is not relevant to that type of information.

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