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The FlexWing Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine(C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The FlexWing Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The FlexWing Anterior Cervical Plate System is made of Titanium Alloy (Ti-6AL-4V) and Nickel-Titanium Alloy, which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI(Extra Low Interstitial) Alloy for Surgical Implant Applications, and ASTM F2063, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. The Anterior Cervical Plates consist of 1 to 3 levels which have different lengths. The bone screws are 3.5 and 4.0mm in diameter with self-tapping and selfdrilling threads and provided in lengths from 10.0 to 26.0mm.

The provided text is a 510(k) summary for the Jeil Medical Corporation's FlexWing Anterior Cervical Plate System. It describes the device, its indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance or AI model evaluation.

The document states: "No clinical studies were considered necessary and performed." This indicates that the regulatory clearance was based on non-clinical testing (mechanical and material tests) and substantial equivalence to existing predicate devices, rather than a study evaluating diagnostic performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets them because such information is not present in the provided text. The device described is a physical implant (Anterior Cervical Plate System), not a diagnostic or AI-powered medical device.

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