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The Synthes 3.5mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.

The Synthes 3.5mm Spring Plate is a variation of the Synthes one-third tubular plate with collar which utilizes two sharp spikes at the bottom surface and a pre-bent convex shape to aid in the reduction of small bone fragments while conforming to bony uneven surfaces. The plate incorporates a 1 - 10 hole design in lengths ranging from 19.5mm - 132mm and accepts either 3.5mm cortex or pelvic screws. In addition the plates are manufactured from Stainless Steel and Commercially Pure Titanium and provided STERILE and NON STERILE.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for the Synthes 3.5mm Spring Plate, outlining its device name, classification, predicate device, description, intended use, and a claim of substantial equivalence to the predicate device. It also includes the FDA's clearance letter.

Therefore, I cannot provide the requested information, as there is no mention of:

• Acceptance criteria table or reported device performance against such criteria.
• Details about a study, including sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth type, or training set information.

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