(102 days)
The ZYFUSE™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from L1 to S1. For transfacet fixation, the screws are inserted posteriorly 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 lamina, through the superior side of the facet, across the facet joint, and into the pedicle.
The ZYFUSE™ Facet Fixation System is indicated for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations.
The ZYFUSE™ Facet Fixation System consists of screws designed to compact juxtaposed facet articular processes to enhance spinal fusion. The cannulated, partially threaded screws are available with or without a washer, and in various diameters and lengths to accommodate patient anatomy. The ZYFUSE™ Facet Fixation System implants are fabricated from medical grade titanium alloy as specified in ASTM F136, F1295 and HA coated as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, titanium alloy implants should not be used in the same construct as stainless steel implants.
The provided text is related to a 510(k) premarket notification for the ZYFUSE™ Facet Fixation System. It describes the device, its intended use, and its basis for substantial equivalence to legally marketed predicate devices.
However, the provided text does NOT contain information regarding:
- Acceptance criteria and reported device performance in a table.
- A study that proves the device meets specific acceptance criteria.
- Sample size for test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory submission for a medical device (a facet fixation system, which is an implantable mechanical device) and not for an AI algorithm or a diagnostic imaging device. Therefore, the types of studies and performance metrics typically associated with AI/software devices (like those you've listed) are not relevant or present in this context.
In summary, based on the provided text, it is not possible to answer the questions about acceptance criteria, study details, expert involvement, and ground truth establishment, as these concepts are not applicable to the type of device and submission described. The 510(k) submission for the ZYFUSE™ Facet Fixation System relies on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use as opposed to performance studies against specific acceptance criteria for AI-based outcomes.
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