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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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The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
2. Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
3. Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.

The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Mini TightRope is designed as either two metal buttons with a pre-threaded FiberWire suture or as one metal button, one bioabsorbable suture anchor with one pre-threaded FiberWire suture.

The provided text is a 510(k) summary for the Arthrex Mini TightRope device. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and does not contain information about acceptance criteria or specific study results to prove device performance in the context of AI/machine learning.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study results, as this type of data is not present in the provided document. The document describes a medical device, its intended use, and its substantial equivalence to other devices, which is a regulatory and functional description rather than a performance evaluation with quantifiable metrics against acceptance criteria.

The information you are asking for, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are characteristic of studies evaluating AI/machine learning medical devices, which this document does not describe.

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