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The NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use is indicated for use in attaining long term vascular access for chronic hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein which should only be used when no other upper extremity or chest wall options are available. Catheters greater than 40cm are indicated for femoral vein insertion.

The NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use (19 cm, 23 cm, 37 cm, 31 cm, 35 cm and 55 cm (tip to cuff lengths) is a dual lumen, symmetric tip radiopaque polyurethane catheter which contains a Dacron biomaterial cuff and two female luer connectors. The DISC (Dermal Ingrowth Support Collar) assists with the direction of the catheter and consists of a biomaterial tissue ingrowth scaffold. The biomaterial scaffolds on the catheter shaft and DISC are aligned and facilitate tissue ingrowth, which is considered important in reducing the source of extraluminal infection in patients requiring long term catheterisation. The Catheter, DISC and the following ancillary components required for the procedure (0.038" guidewire, Stainless Steel Tunneler and Sleeve, 16Fr Introducer / Dilator and Luer Caps) are provided in a tray, sealed with a Tyvek lid and placed in a second sterile pouch so that the tray can be delivered to the sterile field.

The provided text is a 510(k) summary for the Marvao NexSite™ HD, Hemodialysis Symmetric Tip Catheter for long term use. This document describes the device, its intended use, and argues for its substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US.

However, the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is typically found in detailed clinical trial reports or performance study reports, which are not present in this 510(k) summary.

A 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with acceptance criteria for a novel device. The document states that clinical studies were not deemed necessary because in vivo and in vitro testing were sufficient to demonstrate safety and effectiveness by comparison to a legally marketed predicate device.

Therefore,Based on the provided text, I cannot extract the specific information requested about acceptance criteria and a study proving the device meets those criteria.

Here's why and what can be inferred:

• No specific acceptance criteria or study proving they are met are explicitly detailed. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving a novel device meets specific acceptance criteria through a full-scale clinical trial.
• The document states: "In vitro testing was performed on the NexSite HD, Hemodialysis Symmetric Tip Catheter to assure reliable design and performance in accordance with ISO 10555-1:2013." and "The non-clinical tests performed include visual and dimensional of the catheter, DISC and stylet, stylet joint strength, priming volume, catheter leakage, catheter pressure, catheter flow rate testing, catheter recirculation testing and mechanical hemolysis. The test results demonstrate that the NexSite™ HD, Hemodialysis Symmetric Tip Catheter meets the requirements in the applicable standards and specifications, and is substantially equivalent to legally marketed predicate devices."
• It also mentions: "In vivo implantation studies were also performed to demonstrate that the device would perform as intended."
• Crucially, it states: "Clinical studies were not deemed necessary since in vivo and in vitro testing were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device."

This means that while performance testing and in vivo implantation studies were conducted, they were done primarily to establish substantial equivalence to existing devices, usually by showing the new device performs at least as well as the predicate device on the relevant metrics, rather than proving it meets pre-defined acceptance criteria for a novel functionality.

Therefore, I cannot populate the table or answer most of your questions as the document does not contain this level of detail about a dedicated study proving specific acceptance criteria.

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