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The REVLOK™ Fenestrated Screw System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVLOK™ Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVLOK™ Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The REVLOK™ Fenestrated Screw System consists of monoaxial screws, uniplanar screws, polyaxial screws, dual-outer-diameter screws, reduction screws, rods and locking caps. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVLOK™ implants mate with 5.5mm diameter rods, and 6.35mm implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Locking caps are used to connect the screws to the rod.

The most common use of this screw and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws.

The most common use of this screw and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine.

The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F67, F1537 and F138. All other REVLOK™ implants are manufactured from titanium alloy or stainless steel, as specified in ASTM F136, F1295, F138 and F67. The REVLOK™ Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.

This is a 510(k) premarket notification for a medical device (Globus Medical, Inc.'s REVLOK™ Fenestrated Screw System), not an AI/ML device. Therefore, the provided information does not contain the specific acceptance criteria and study details outlined in your request.

The document discusses the substantial equivalence of the REVLOK™ Fenestrated Screw System to predicate devices based on mechanical testing, not clinical performance metrics related to AI or human reader improvement.

Here's why the requested information about AI/ML device acceptance criteria and studies cannot be extracted from this document:

• Device Type: The REVLOK™ Fenestrated Screw System is a spinal implant system (screws, rods, locking caps). It is a physical medical device, not a software algorithm or AI/ML diagnostic tool.
• Regulatory Pathway: A 510(k) submission generally demonstrates substantial equivalence to a legally marketed predicate device. This often involves comparing device design, materials, manufacturing processes, and performance (e.g., mechanical strength) to the predicate. It does not typically involve clinical studies with human readers, ground truth consensus, or AI performance metrics.
• Performance Data: The document states, "Mechanical testing (static and dynamic compression and static torsional) was conducted in accordance with ASTM F1717 and the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device." This refers to physical engineering tests, not AI-related performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer the questions about sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided 510(k) summary for this mechanical spinal implant system.

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