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The Proficient™ Facet Screw Spine System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, without bone graft, at single or multiple levels, from C2 to S1. The Proficient™ Facet Screw Spine System is intended for transfacet fixation, in which the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. The Proficient™ Facet Screw Spine 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
• · Trauma including spinal fractures and/or dislocations

The Proficient™ Facet Screw Spine System consists of a selection of non-sterile, single use screws manufactured from titanium alloy conforming to ASTM F136. The screws are provided in multiple diameters and various lengths to accommodate variations in patient anatomy.

This document describes a 510(k) premarket notification for a medical device called the "Proficient™ Facet Screw Spine System". The document is a clearance letter from the FDA to Spine Wave, Incorporated, confirming that their device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, or algorithm-only performance. This device is a physical implant (facet screw system) and the "performance data" refers to mechanical testing of the implant itself, not a diagnostic or AI-driven system.

Therefore, I cannot populate the table or answer the specific questions about AI/diagnostic device performance because such information is not present in the provided FDA 510(k) clearance letter for a mechanical implant. The performance data mentioned (Static and dynamic three-point bending, Axial pullout, Torque to failure) are mechanical tests to demonstrate the structural integrity and functionality of the physical screws, not a clinical study to evaluate software performance or diagnostic accuracy.

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