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The Pioncer Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.

The Pioneer Anterior Cervical Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

This document is a 510(k) summary for the Pioneer Anterior Cervical Plate System, a medical device for spinal intervertebral body fixation. The content provided does not describe an AI/ML powered device, and therefore does not contain information about acceptance criteria or specific studies to prove performance in the context of an AI/ML device.

The document discusses the device description, intended use, and comparison to predicate devices for a determination of substantial equivalence to already legally marketed devices. It also includes the FDA's decision letter regarding market clearance.

Therefore, I cannot fulfill the request as the provided text does not contain the pertinent information for an AI/ML device.

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