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The titanium alloy Mini plate is provided non-sterile. The device is intended to treat fractures of various bones, including the clavicle, scapula, pelvis, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and plialanges).

The Mini plate is device, which is fastened to bone for purpose of providing fixation. The device is principally differentiated by its function. Thus there is various types and sizes of bone fixation plates. The Mini plate is geometry shape as follows: Straight, L-shaped, T-shaped, H-shaped, Condylar, Cloverleaf, Calcaneal, and Straight Reconstruction. The plate must be used for various sizes of screw onto bone fixation. The device range in thickness from 0.9 to 2.8 mm, width from 3.8 to 15.2 mm, length from 17 to 262 mm, and hole number from 3 to 22 holes.

I am sorry, but the provided text only contains regulatory information and a description of the device (Syntec-Taichung Non-sterile Titanium Alloy Mini Plate). It does not include any information regarding acceptance criteria, study details, performance data, or ground truth establishment for the device.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets the acceptance criteria. The document is primarily a 510(k) clearance letter from the FDA, confirming substantial equivalence to a predicate device.

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