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The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy. The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries.

The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies or trauma fracture.

EIS Dynamic Memory Staples System

This is a 510(k) clearance letter for the EIS Dynamic Memory Staples System, a medical device. The letter states that the device is substantially equivalent to legally marketed predicate devices, and therefore, can be marketed.
However, this document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device. It only provides regulatory clearance for a physical medical device (staples system). Therefore, I cannot extract the requested information.

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The Groupe Lepine EIS threaded compression screw system is intended to be used as a fixation screw of the first metatarsal after a corrective osteotomy, or for fixation of small bones after trauma fractures.

The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or trauma fractures.

EIS Threaded Compression Screw System

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the EIS Threaded Screws for Metatarsal Fixation, which describes the device's intended use and market clearance, but does not include any details about acceptance criteria, a study validating the device's performance, or the specific information you've requested regarding AI or clinical studies.

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