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TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) 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)
• Degenerative Spondylolisthesis with objective evidence of neurologic impairment
• Fractures
• Dislocation
• Scoliosis
• Kyphosis
• Spinal tumor
• Failed previous fusion (pseudarthrosis)

TREND II Spinal Fixation System- STEP Series includes cannulated screw, non-cannulated screw, rod, set screw, hook, and transverse link. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

This document is a 510(k) premarket notification from the FDA, focusing on the substantial equivalence of "TREND II Spinal Fixation System- STEP Series" to predicate devices. It does not describe an AI medical device or a study involving human-in-the-loop or standalone AI performance. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI device.

The document primarily discusses:

• Device Type: Thoracolumbosacral pedicle screw system (a traditional medical implant, not AI)
• Regulatory Class: Class II
• Product Code: NKB
• Indications for Use: Spinal immobilization and stabilization for various conditions (e.g., degenerative disc disease, fractures, scoliosis)
• Predicate Devices: Comparison to "Paonan" Armstrong Posterior Spinal Fixation System (K161225) and MYKRES Spinal System (K051704).
• Performance Data: Mechanical testing (static/dynamic axial compression bending, static torsion, pullout test) to demonstrate substantial equivalence, referring to ASTM F1717 and ASTM F543. These are engineering performance tests for physical implants, not AI algorithm performance.

Therefore, it is impossible to provide the requested information about acceptance criteria and an AI study from this document.

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