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When used as a cervical intervertebral body fusion device, the Republic Spine Restore Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms 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 autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Republic Spine Restore Cervical Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Republic Spine Restore cervical interbody fusion device, which is intended to be implanted as a single device via an anterior approach.

The provided text is a 510(k) premarket notification for a medical device (Republic Spine Restore Cervical Interbody Fusion System). It does not contain information related to an AI/ML-based medical device study, acceptance criteria, or performance data for such a study.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets these criteria based on the input provided. The document describes mechanical testing for an implantable device, not a study evaluating an AI system's performance.

To answer your request, I would need a document detailing the clinical performance study of an AI-powered medical device, including information on its acceptance criteria, study design, expert involvement, and ground truth establishment.

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