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The Acumed Small Bone IM Nail System is intended for fixation of fractures of the fibula, and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.

The Acumed Small Bone IM Nail is a titanium alloy (Ti-6Al-4V) intramedullary rod/nail manufactured in multiple lengths (110mm to 270mm) and diameters (2.6mm to 4.0mm). The nails have openings used in conjunction with titanium alloy cortical screws, which lock them in place. The nails are compatible with an optional far-end locking (FEL) bushing and set screw that provide a locking option at the distal end of the nail. The nails are also compatible with optional end caps that thread into the proximal portion of the nail to provide additional length if desired. All implants are provided both sterile and non-sterile.

The provided text describes a 510(k) premarket notification for the "Acumed Small Bone IM Nail System," which is an intramedullary fixation rod. The document details the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria, specific device performance metrics, detailed study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.

The non-clinical testing section only states that:

"Comparative testing between the Acumed Small Bone IM Nailing system and a predicate device was conducted as per ASTM F1264-03. The test data showed the Acumed Small Bone IM Nail was substantially equivalent to the predicate device in a static four-point bend test, static torsion test, and bending fatigue test as described herein."

This statement confirms that testing was done to demonstrate substantial equivalence, but it does not provide the quantitative acceptance criteria or the specific performance results in a way that allows for the creation of the requested table. It also lacks all other requested information about sample sizes, ground truth, experts, and study types.

Therefore, I cannot fulfill the request to provide the table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The document focuses on regulatory approval through substantial equivalence, which often relies on demonstrating similar physical and mechanical properties to existing devices rather than extensive clinical performance studies with acceptance criteria in the manner requested for AI or diagnostic devices.

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