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Leaderflex catheters are indicated for:

• Arterial catheterization in adults
• Central venous catheterization (jugular, subclavian) in children
• Peripheral venous catheterization (Midline) in any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure

Leaderflex is a radiopaque biostable polyurethane catheter suitable for a variety of venous and arterial applications. Leaderflex is inserted via Seldinger technique.

The provided text is a 510(k) Premarket Notification submission for the Leaderflex catheter. The document does not describe an acceptance criteria table, a study proving device performance against such criteria, or any of the detailed study parameters requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that the manufacturer is asserting their device is as safe and effective as devices already legally marketed, rather than presenting new clinical study data to prove performance against specific acceptance criteria.

The key points from the provided text are:

• Device: Leaderflex intravascular catheter
• Intended Use: Arterial catheterization in adults, central venous catheterization in children, peripheral venous catheterization (Midline) in any patient population.
• Predicate Devices: Vygon Leaderflex (K052564), Bard Powerglide Midline Catheter (K121073), Bard Poly Per-Q-Cath Midline (K001901).
• Demonstration of Equivalence: The submission states, "Leaderflex is identical to the legally marketed Vygon predicate device. The subject device shares the midline indication with both the Bard Powerglide and Poly Per-Q-Cath Midline catheters. A risk analysis has been completed to show that the safety and effectiveness of the device has not been altered with the addition of the midline indication." This is the core of their argument for substantial equivalence.

Therefore, I cannot populate the requested table or provide information on the study parameters because the document does not contain this type of performance data or study design. The FDA's 510(k) clearance in this case is based on the claim of substantial equivalence to existing devices, not on new clinical performance data meeting specific criteria.

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