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The Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.

The Synthes Elastic Intramedullary Nail (EIN) End Cap is used with the Synthes Elastic Intramedullary Nail (EIN) System. The end cap is inserted over the external portion of the nail and threaded into the cancellous bone in an oblique orientation.

The provided text describes a 510(k) summary for a medical device, the "Synthes (USA) Elastic Intramedullary Nail (EIN) End Cap, Line Extension". This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics in the way a novel AI/software device would.

Therefore, the document does not contain the information typically required to fill out a table of acceptance criteria and reported device performance for an AI/software device, nor does it describe a study like those requested in questions 2 through 9.

Here's why and what information is available:

• Type of Device: This is an implantable medical device (intramedullary nail end cap), not an AI or software device. Substantial equivalence for such devices often relies on comparison of design, materials, manufacturing processes, and intended use to a predicate device, rather than performance metrics from a clinical study with ground truth.
• Regulatory Pathway: The 510(k) pathway (K082148) for this device is focused on showing substantial equivalence to existing predicate devices (Synthes Stainless Steel Elastic Intramedullary Nail (EIN) System - K081452 and Synthes Elastic Intramedullary Nail (EIN) End Cap - K053105).
• Lack of Performance Data: The 510(k) summary explicitly states "Information presented supports substantial equivalence" but provides no information about acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, F-score), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details. These are all concepts relevant to the evaluation of AI/software as a medical device (SaMD) or AI-assisted devices, which this product is not.

In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a traditional medical device undergoing a 510(k) substantial equivalence review, not an AI/software device with performance criteria and a study as typically outlined for such technologies.

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