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JMS Extension Set with Planecta™, Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor are accessories and to be used with a primary vascular access device for fluid administration and blood sampling. Planecta™ with a luer slip syringe or male luer connector to allow needle-less access to the vascular path for injection or withdrawal of fluids or blood. Planecta™ Lock / Adaptor will be used as an adaptor for connection with luer lock syringe or other lock-connecting devices. These device accessories are intended for single use only.

JMS Extension Set with Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor will reduce the risk of accidental needle stick injury as a needle will not be used or required throughout the procedure for injection or withdrawal of fluid.

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The provided text is a 510(k) premarket notification letter from the FDA regarding an intravascular administration set. It discusses regulatory information, classification, and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval letter and does not delve into the specific details of the technical studies underpinning the device's substantial equivalence.

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