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The Arthrex RetroButton™ for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.

The Arthrex RetroButton™ is a pre-threaded button construct.

The provided text is a 510(k) summary for the Arthrex RetroButton™, a medical device used for fixation of bone to bone or soft tissue to bone, specifically for Anterior Cruciate Ligament (ACL) Repair.

The document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Arthrex FiberWire® Button Repair Kit K031666).

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth establishment for training set" are typically associated with performance studies conducted for medical devices, often when a new technology is introduced or significant changes are made.

In this 510(k) submission, the primary method of demonstrating safety and effectiveness is through substantial equivalence to an already legally marketed device. This means the manufacturer argues that the new device is as safe and effective as the predicate device because it shares similar technological characteristics and intended uses, without necessarily requiring new clinical performance data or studies against specific acceptance criteria.

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