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The 14.5 Fr Chronic Hemodialysis Catheter with Symmetrical Tip (Palindrome™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque polydiethane shalt with two large infost was to a symmetrical tip configuration. The proximal rne distall one of the catheter a polyurethane hub assembly and sillcone extension sets.

The provided text describes a 510(k) premarket notification for a medical device, specifically a hemodialysis catheter. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The document focuses on establishing substantial equivalence to a predicate device based on intended use, materials, physical characteristics, and performance characteristics, but it does not detail specific performance data or a study design.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent questions regarding sample sizes, ground truth, expert involvement, or adjudication methods, as this information is not present in the provided text.

The text mentions: "Performance Data: Performance data for the 14.5 Fr Chronic Hemodialysis Catheter r en offinance Data: P Chomars and for the Predicate device with Symmetrical Tip (Palindrome™) is compared to that of the predicate device identified in this 510(K) summary. the modified device is substantially equivalent to the legally marketed device." This statement indicates that performance data was considered in the submission, but the actual data, acceptance criteria, and study details are notably absent from this summary.

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