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The Y 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. 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 (FR 801.109(b)(1))

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the V Set device. The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It defines the device, its intended use, and regulatory information, but does not include any performance data or study details.

Therefore, I cannot provide the requested information in the specified format.

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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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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, study details, or performance metrics of the device as it pertains to AI or software algorithms.

Therefore, I cannot answer your request based on the provided input. The document
describes the regulatory approval process for the "Go Medical Patient Controlled Analgesia (PCA) Devices" and confirms its substantial equivalence to a legally marketed predicate device. It does not assess or report on any AI-driven performance or studies related to such.

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