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The V Set is suitable for intravenous infusion of drug solutions and fluids and has been designed to connect multiple infusion lines, functioning in the administration of intravenous fluids from a number of sources into one cannula.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance, or any of the other specific details requested in your prompt.

The document is a letter from the FDA to Henning Enterprises Europe S.R.L. regarding their "V Set" device. It is a 510(k) premarket notification letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It also includes an "Indications for Use Statement" for the V Set.

This type of document typically confirms regulatory clearance but does not contain detailed study results, acceptance criteria, or performance metrics.

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Go Medical Patient Controlled Analgesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))

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This document is a 510(k) clearance letter from the FDA for a medical device, specifically "Go Medical Patient Controlled Analgesia Devices (PCA) Devices." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It outlines regulatory requirements that the manufacturer must adhere to, such as registration, listing, good manufacturing practices, and labeling.

Therefore, I cannot provide the requested information based on the content of this document.

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