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TriMed Posterior Malleolus Fixation System is indicated for fractures, osteotomies, and non-unions of the distal tibia.

TriMed Posterior Malleolus Fixation System plates and screws are manufactured from medical grade stainless steel. Posterior Malleolar L-Plates and T-Plates accept 2.7mm and 3.2mm locking and non-locking screws.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "TriMed Posterior Malleolus Fixation System," which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on specific performance acceptance criteria and a study to meet them.

The relevant sections describe:

• The FDA's decision to clear the device.
• The device's indications for use.
• A comparison of the device to its predicate in terms of materials, design, principles of operation, packaging, and labeling.
• Mention of static and endurance testing for the plates and screw testing as per FDA guidance, indicating that the new device performed "superior" in static testing compared to the predicate. However, it does not provide specific acceptance criteria (e.g., "device must withstand X Newtons of force to be considered acceptable") or detailed results against such criteria.
• A clear statement that "Clinical studies were not conducted for the subject devices."

Therefore, I cannot extract the requested information to populate the table or answer the specific questions about sample size, ground truth, expert involvement, or MRMC studies.

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