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The Life Spine Facet Screw Spinal System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spondylosis, fracture, degeneration of the facets with instability, pseudoarthrosis, and failed previous fusion.

The Life Spine Facet Screw System, when properly used, is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. The Life Spine Facet Screw System is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels, from L1 to S1.

The Life Spine Facet Screw Spinal System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), screw and washer system comprised of a variety of sizes of non-sterile, single use implantable components. The facet screw system consists of broad-headed, partially threaded screws designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability.

The provided document is a 510(k) summary for the Life Spine Facet Screw Spinal System. It details the device description, intended use, material, and substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The 510(k) process for devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria that report on performance metrics. The document explicitly states:

"The Life Spine Facet Screw Spinal System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used."

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies because the provided text does not contain that information. The document is primarily a regulatory submission demonstrating equivalence, not a clinical study report.

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