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The EUROPA™ Posterior Cervical Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):

• · Traumatic spinal fractures and/or traumatic dislocations
• · Instability or deformity
• · Failed previous fusions (e.g. pseudarthrosis)
• · Tumors involving the cervical/thoracic spine
• · Degenerative disease, including intractable radiculopathy and/or myelopathy
• · Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
• · Degenerative disease of the facets with instability

The EUROPA™ Posterior Cervical Fusion System is also intended to restore the intearity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the EUROPA™ Posterior Cervical Fusion System may be connected to the EUROPA™ Pedicle Screw System via the rod to rod connectors.

The EUROPA™ Posterior Cervical Fusion System is a posterior cervical screw system intended to provide structural stability and mechanical support to the cervical spine following posterior cervical fusion.
The EUROPA™ Posterior Cervical Fusion System consists of rods manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, pedicle screws and connectors manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The EUROPA™ Posterior Cervical Fusion System implants are offered in multiple configurations and different sizes to accommodate various patient anatomical requirements.
The rods are provided sterile packed and are intended for single use only. The pedicle screws and connectors must be steam sterilized prior to use.

The provided text is related to the FDA 510(k) clearance for the EUROPA™ Posterior Cervical Fusion System. It details the device's intended use, indications, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices.

However, the request asks for information about the acceptance criteria and the study that proves an AI/software device meets the acceptance criteria, including details like sample size, ground truth establishment, expert qualifications, and MRMC studies.

The EUROPA™ Posterior Cervical Fusion System is a physical medical device (a posterior cervical screw system), not an AI or software device. The provided document does not contain any information about AI/software performance, nor does it describe studies with human readers, radiologists, or ground truth established by experts for an AI system.

Therefore, I cannot extract the requested information regarding AI/software device acceptance criteria and study details from the provided text. The document focuses on demonstrating the mechanical performance and material equivalence of a physical implant system.

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