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The OsseoScrew™ System (for use with the Zodiac™ Spinal Fixation System and Illico™ MIS Posterior Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The OsseoScrew is a pedicle screw system that consists of pedicle screws and associated general instruments. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient.

The subject cannulated polyaxial pedicle screws are in diameters of 6.5mm and 7.5mm with lengths ranging from 40 to 55mm. The OsseoScrew is designed to connect to 5.5mm diameter rods and the associated components contained within the Zodiac Spinal Fixation System and the Illico MIS Posterior Spinal Fixation Systems.

The Alphatec Spine OsseoScrew System is an implantable pedicle screw device whose core is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and the expandable screw shank is manufactured from CP2 Titanium conforming to ASTM F67 which are both industry recognized standards.

The provided text is a 510(k) summary for the Alphatec Spine, Inc. OsseoScrew System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance data and engineering analysis. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information related to human performance, ground truth establishment, or sample sizes beyond the general statement that "Clinical data on the subject device has been provided to support a substantial equivalence determination."

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes for training/test sets, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document.

The document focuses on demonstrating substantial equivalence through:

• Technological Comparison: Comparing intended use, indications for use, design, function, and technology to predicate devices.
• Performance Data and Engineering Analysis: Mentioning static shank torsion, static shank tensile, dynamic shank bending, dynamic construct compression, and static construct compression testing.
• Clinical Data: Stating that clinical data was provided to support substantial equivalence.

Without further information about the specific "Clinical data" and "Performance data" mentioned, it's impossible to
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