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The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surqical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery include a variety of plate configurations for different anatomical applications. Unalloyed commercial pure Grade 1, 2 and 4 titanium, titanium alloy plates as well as titanium alloy screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial tissues.

The provided document does not contain information about acceptance criteria or a study proving the device meets them. It's a 510(k) premarket notification for a medical device (bone fixation plates for craniomaxillofacial surgery), and the FDA letter indicates that the device has been found substantially equivalent to predicate devices.

Therefore, I cannot provide the requested table and study details.

Here's why the information isn't present in this document:

• 510(k) Substantial Equivalence: This regulatory pathway (510(k)) primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use, not necessarily providing new performance studies against specific acceptance criteria.
• Lack of Clinical Study Details: The document focuses on regulatory classification, intended use, and comparison to predicate devices, not on detailed clinical trial results or performance against quantitative acceptance criteria for a novel technology like an AI device would require.
• Device Type: The device described is a physical medical implant (bone fixation plates), not an AI/software as a medical device (SaMD). Performance for such physical devices is often evaluated through bench testing, material properties, and sometimes animal studies, rather than the types of clinical or reader studies described in your prompt for AI.

If you are looking for information regarding acceptance criteria and performance studies for an AI/SaMD, you would typically find that in a much more detailed clinical study report or a different section of a regulatory submission.

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