(100 days)
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The FaSet Screw Systems is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posterior through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for any or all of the following:
· Spondylolisthesis
· Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity
· Spondylolysis
· Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability
· Trauma including spinal fractures and/or dislocations
The FaSet Fixation System consist of permanent implant devices manufactured from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, and F136. Various sizes and lengths of these implants are available to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved.
This document is a 510(k) premarket notification from the FDA for the FaSet Fixation System, a medical device used for spinal fusion. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical testing and does not contain information about software or AI-based performance criteria, clinical study results with human readers, or ground truth establishment relevant to AI/ML device evaluations.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device. The provided text is solely about a physical implant device and its mechanical performance.
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