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Synthes Ti Alloy VDRP is intended for fixation of fractures and osteotomies of the distal radius, applied to the volar aspect.

The plate is T-shaped (with the head 10° from perpendicular to the shaft), pre-contoured, and available in right and left versions. The head can be cut to size, and has up to six threaded holes that accept either 2.4 mm cortex screws or 1.8 mm buttress pins. The shaft can also be cut to size, has up to five compression holes (two being elongated shaft holes to facilitate positioning), and accepts 2.7 mm cortex screws. As is stated in its name, the plate is manufactured from a Ti Alloy. Synthes Ti Alloy will be provided both sterile and non-sterile.

The provided text is a summary of safety and effectiveness information for a medical device (Synthes Ti Alloy VDRP), comparing it to existing Synthes VDRP and Synthes STP products. However, it does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria in the context of AI/ML or diagnostic accuracy. Instead, it describes:

• Device Description: Details about the Synthes Ti Alloy VDRP, its design, materials (Ti Alloy), and intended use (fixation of fractures and osteotomies of the distal radius).
• Comparison to Other Devices: Mentions that it's compared to existing Synthes VDRP (made of CP Titanium) and Synthes STP (made of 316L stainless steel).
• Sterilization Information: Specifies sterile and non-sterile options and recommended sterilization methods.
• Mechanical Testing: States that mechanical testing was performed and, based on its results, the Ti Alloy VDRP and CP Titanium VDRP are at least equivalent to the Synthes STP.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study design for performance, sample sizes, expert ground truth, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The text pertains to a traditional medical device (a plate for bone fixation) and its mechanical equivalence to other similar plates, not to a diagnostic or AI/ML device performance study as implied by your detailed list of requested information.

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