(97 days)
The AERO MIS Facet Fusion System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
- Spondylolisthesis,
- Spondylolysis,
- Pseudoarthrosis or failed previous fusions which are symptomatic, or
- Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability.
The system is intended for use with bone graft material.
The AERO MIS Facet Fusion System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.
I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "AERO MIS Facet Fusion System." This document discusses the regulatory approval process and states that the device is "substantially equivalent" to a previously cleared predicate device based on its indications for use, design, function, materials, and performance.
However, the text does not contain any information about acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria, as the necessary information is not present in the provided document.
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