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The Mercury® Spinal System is intended to provide immobilization of the spine in skeletally mature patients as an adjunct to fusion for procedures of the thoracic, lumbar, and sacral spine (T1-S1). Screws may be placed from the thoracic spine through the sacral spine and into the ilium. This system is intended for anterior/ateral nonpedicle fixation, posterior non-pedicle fixation pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

This system is intended to be used with bone graft.

Spinal Elements' Mercury Spinal System is comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine (the thoracic spine through the sacrum and into the ilium). A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient. Rods span the distance between screws and hooks and achieve fixation by the mechanical joining of the rods with the screws or hooks. Connectors are used to mechanically join one rod to another. Staples (when used) are placed under the screws to help distribute loads placed against the bone. Screws, hooks, rods, connectors, and staples are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136, ASTM F 1472 or ISO 5832-3. Additionally, some rods may be manufactured from cobalt chromium alloy (Co-Cr) conforming to ASTM F 1537 and ISO 5832-12.

This document describes the Mercury® Spinal System, a medical device, and its regulatory clearance. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical image analysis. Therefore, I cannot provide an answer that addresses the requested points regarding acceptance criteria, study details, expert involvement, or AI performance metrics.

The provided text details the following:

• Device Name: Mercury® Spinal System
• Manufacturer: Spinal Elements Inc.
• Regulatory Clearance: K172967
• Device Type: Thoracolumbosacral pedicle screw system
• Intended Use: Immobilization and stabilization of the spine as an adjunct to fusion for various spinal conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, failed previous fusion).
• Materials: Titanium alloy (Ti-6Al-4V) and Cobalt Chromium alloy (Co-Cr).
• Substantial Equivalence: Claimed to be substantially equivalent to previously cleared Mercury Spinal System predicate devices (K071914, K082353, K083230, K091587, K141372, K151215).
• Performance Data: States that performance testing included Static Axial Grip and Torsional Grip Interconnection Testing per ASTM F 1717 and ASTM F 1798, and Static and Dynamic Flexion/Extension Testing per ASTM F 1798. It concludes that "All data indicates that the device will perform as intended."

To reiterate, the original text does not contain the information required to answer your specific questions related to AI device performance evaluation.

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