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The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-weight bearing fixation. including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for a medical device (Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) which asserts "substantial equivalence" to previously marketed predicate devices.

The document states: "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." This indicates that the device's characteristics were compared to existing, approved devices, and no new studies demonstrating performance against specific acceptance criteria were necessary for this 510(k) clearance process.

Therefore, I cannot provide the requested information in the table or address points 2 through 9, as they pertain to a type of study that was not described or performed for this specific submission based on the provided text.

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