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The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the patient, and waste handling. All drug transferring utilizes a patented double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) premarket notification summary for a medical device (PhaSeal Infusion Adapter). It describes the device, its intended use, and states its substantial equivalence to previously accepted PhaSeal devices. The letter from the FDA confirms the substantial equivalence determination and permits the device to proceed to market, subject to general controls and regulations.

The text does not include:

• A table of acceptance criteria or reported device performance.
• Details about a sample size, test set, data provenance, or ground truth establishment.
• Information regarding expert involvement, adjudication methods, or MRMC studies.
• Any standalone algorithm performance data.
• Details about a training set or its ground truth.

Therefore, I cannot fulfill your request for this specific information using the provided document.

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