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The Vial2Bag Advanced™ 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient.

The Vial2Bag Advanced [M 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced1™ 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device is limited to a single device configuration. Users should not attach a Vial2Bag Advanced™ 20 mm Admixture Device to another Vial2Bag Advanced™ 20mm Admixture Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced™ 20mm Admixture Device for the device to meet its intended purpose.

The provided text is a 510(k) summary for a medical device (Vial2Bag Advanced™ 20mm Admixture Device) and does not describe a study involving an AI/Machine Learning diagnostic device. Therefore, I cannot extract information related to acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details as these concepts are not applicable to the information provided.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Indications for Use: The device is indicated to serve as a connection between an IV bag, vial, and an external IV administration set for reconstituting and/or admixing drugs.
• Performance Testing: Bench tests were conducted to ensure the device met design and performance requirements, conformity to standards (ISO 8536-42010/ Amd.1:2013), and internal specifications (e.g., tensile detachment force, leakage).
• Biocompatibility Testing: Tests were performed according to ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, systemic (subacute) toxicity, ASTM hemolysis, and particulate testing.
• Sterilization: The device relies on Ethylene Oxide sterilization, validated to ISO 11135:2014, achieving a sterility assurance level (SAL) of 10-6.
• No Clinical Data: The document explicitly states, "No clinical trial was performed for Vial2Bag Advanced™ 20mm Admixture Device."

The acceptance criteria for this type of device would primarily be related to its physical performance, safety (biocompatibility), and sterility, rather than diagnostic accuracy or human reader improvement, as it is a fluid transfer device, not an AI-powered diagnostic tool.

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