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The Suture Button Repair System is intended for fixation of bone and soft tissue in upper extremity orthopedic procedures requiring ligament or tendon reconstruction in the hand, wrist, forearm, elbow and shoulder.

The Suture Button Repair System is comprised of the following Suture Button configurations in conjunction with accessories: (1) Distal Bicep Suture Button Repair configuration, (2) IOL Suture Button-Repair configuration and (3) CMC Suture Button Repair configuration. The implants are provided sterile for single use. The instruments are provided non-sterile and shall be sterilized by the end user.

The provided FDA 510(k) summary for the "Suture Button Repair System" does not describe a study involving an AI/Machine Learning device or a diagnostic device that requires establishment of ground truth by experts or a multi-reader multi-case (MRMC) comparative effectiveness study.

Instead, this document is a 510(k) submission for a surgical implant (Suture Button Repair System) and focuses on demonstrating substantial equivalence to a predicate device. The performance testing described is primarily bench-top mechanical testing and standard regulatory tests for medical devices (sterilization, biocompatibility, stability).

Therefore, I cannot extract the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device and submission described in the input document.

The document states:

• "Non-clinical performance testing for the Suture Button Repair System included sterilization validation... biocompatibility testing... stability testing... The Suture Button Repair System was also evaluated for strength and elongation during cyclic loading and ultimate load to failure conditions." (Page 4)
• "Bench top performance testing demonstrated substantially equivalent mechanical performance as the predicate device." (Page 5)

This indicates that the "study" proving the device meets acceptance criteria was a series of engineering/mechanical tests, not a clinical study involving interpretation of images or data by human readers or AI.

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