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Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.

Synthes 3.5 mm Low Profile Pelvic Reconstruction Plates consist of curved plates and straight plates that are contourable in three planes. The plates have a smooth, rounded profile. Plate holes are slightly oval, allowing 30 degrees of angulation in all directions. The 3.5 mm Low Profile Reconstruction Plate accepts Synthes 3.5 mm Cortex Screws and Synthes 3.5 mm Pelvic Screws.

I am sorry, but the provided text describes a medical device (Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate) and its regulatory clearance (510(k) summary). There is no information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/ML algorithm or its performance.

The document discusses:

• Sponsor, contact, device name, classification, and predicate device.
• Device description, intended use, and materials.
• Regulatory review process by the FDA for substantial equivalence to a predicate device.
• Indications for use statement for the surgical plate.

Therefore, I cannot extract the information you requested regarding acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies because this information is not present in the provided text.

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