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The 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters greater than 40 cm implant length are indicated for femoral placement.

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip configuration. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets.

The provided text is a 510(k) Premarket Notification for a medical device (Palindrome 14.5Fr Chronic Hemodialysis Catheter with slotted symmetrical tip). It asserts substantial equivalence to a predicate device and includes details about its description, intended use, and regulatory classification.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes for testing/training, expert involvement, or comparative effectiveness studies. The "Performance Data" section simply states that verification/validation results demonstrate substantial equivalence to the predicate device based on comparison, but offers no specific data or methodology.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about study details regarding AI or human reader improvement, as this information is not present in the provided text.

The document primarily focuses on regulatory approval and substantial equivalence with a predicate device, rather than a detailed performance study against specific acceptance criteria.

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