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The Merit Centros and CentrosFLO Long-Term Hemodialysis Catheter for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. This catheter is indicated for > 30 days, (long-term) placement.

The Centros and CentrosFLO Long-Term Hemodialysis Catheters are dual lumen, 15FR catheters available in lengths ranging from 15 to 31 cm (cuff-to-tip). The catheter comes with a stiffening stylet that can be used for over-the-wire placement. The catheter lumens are D-shaped and made from radiopaque polyurethane. The distal end design is a fixed length pre-formed split-tip, with (CentrosFLO) or without (Centros) side-holes. The distal venous lumen extends past the arterial lumen, and includes a guide wire slit for insertion by the optional over-the-wire placement technique. The proximal device contains a fixed polyester cuff, an integrated bifurcation, suture wing, and extension legs with color coded occlusion clamps and Luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on ID tags within the occlusion clamps. The trade name and cuff-to-tip length are printed on the catheter bifurcation. The catheter is a single-use device provided sterile via ethylene oxide for long-term (> 30 days) use. The Centros and CentrosFLO Long-Term Hemodialysis Catheters are marketed with any of the following components, depending on the product configuration: stylet, introducer, dilator(s), tunneler with sheath, introducer needle, scalpel, guide wire, adhesive wound dressings,

I am sorry, but the provided text is a Formal document from the FDA (Food and Drug Administration) about a 510(k) premarket notification for a medical device. It does not provide information about acceptance criteria and how a study proves a device meets those criteria. The document mainly discusses the substantial equivalence of the "Merit Centros® and CentrosFLO® Long-Term Hemodialysis Catheter" to a predicate device and outlines the regulatory framework.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth, or training set details from the given text.

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