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The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (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.

The EUROPA™ Pedicle Screw System is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements.

The pedicle screws are manufactured from Ti-6Al-4V ELI alloy (ASTM F136). The rods are manufactured from Molybdenum-47.5Rhenium alloy (ASTM F3273) or cobalt chromium alloy (ASTM F1537).

The system also includes adjustable-length transverse rod cross connectors manufactured from Ti-6Al-4V ELI alloy (ASTM F136-13) that may be used in EUROPA™ systems with cobalt chromium rods where increased structural rigidity of the construct is needed.

The purpose of this 510(k) submission is to obtain market clearance for additional EUROPA™ Pedicle Screw System rod to rod connectors manufactured from Ti-6AI-4V ELI alloy (ASTM F136-13) which may be used to connect or extend constructs in an in-line or parallel fashion.

This document, a 510(k) summary for the Europa Pedicle Screw System, describes a medical device, specifically a pedicle screw system for spinal fixation, and its substantial equivalence to previously marketed devices. It does not contain any information about an AI/ML powered device, acceptance criteria, or a study that proves the device meets acceptance criteria.

Therefore, I cannot fulfill your request as the provided text does not contain the necessary information regarding:

• Acceptance criteria for an AI/ML device.
• Reported device performance against such criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Expert involvement in ground truth establishment or adjudication.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Ground truth methodology.

The supplied text is a standard FDA 510(k) clearance letter and summary for a physical medical implant (pedicle screw system), focusing on its mechanical performance and substantial equivalence to predicates, not on AI/ML diagnostic or assistive technology.

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