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The Arisure™ Dry Spike allows for the addition of liquid medications to IV containers through a needle-free access port, and serves as a connector between an IV container and a standard IV set, while minimizing exposure to drug aerosols and spills.

The Arisure™ Dry Spike connects between IV containers and standard IV sets for the addition or removal of fluids. A needle-free valve on the side of the device provides a swab-able female access port for connection with ISO standard male luers. The needlefree valve provides an alternative fluid path to the IV container, which is normally accessed via a dedicated lumen within the spike. A pierceable septum distal to the device's spike, incorporates a redundant seal ring to minimize or eliminate fluid leakage that might otherwise occur during the spiking of IV containers. Fluid within the bag is then administered through a second, primary lumen within the spike. A third, vented lumen incorporates a check valve with hydrophobic vent media to equalize vacuum created within rigid containers and glass bottles during the administration of fluids.

The Arisure™ Dry Spike was designed to comply with ISO 8536-4:2010 as appropriate. The primary components of the Arisure Dry Spike include a vented lumen, handle, and needle-free valve, which are made of ABS, TPE, and PC/Silicone respectively. All materials were tested in accordance with ISO 10993-1.

The provided text describes the Arisure™ Dry Spike, an intravascular administration set, and its equivalence to a predicate device. However, it does not contain information about an AI/ML powered device, hence acceptance criteria for such a device, and the study proving it meets the criteria, cannot be extracted.

The document is a 510(k) premarket notification for a medical device (Arisure™ Dry Spike) to the FDA. The purpose of this document is to demonstrate substantial equivalence to a legally marketed predicate device (PhaSeal® Infusion Adapter).

While there is a "Performance Testing" section, it describes bench tests and biological/chemical compatibility tests for the physical device, not for an AI/ML algorithm.

Therefore, the specific information requested in your prompt (Table of acceptance criteria and device performance for an AI/ML device, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in the provided text.

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