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The Arisure™ Neutral Valve is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for the administration or withdrawal of fluids from a patient through a cannula placed in the vein or artery. The Arisure™ Neutral Valve may be used with low-pressure power injectors up to 300 psi.

The Arisure™ Neutral Valve is a sterile, single-use, swab-able, normally closed, luer-activated, valved connector. The Arisure™ Neutral Valve consists of five primary components: lower housing, upper housing, retention ring, pre-slit silicone piston, and lubricating silicone oil. The lower housing, made of polycarbonate, consists of a male luer and a long feature that provides support for the silicone piston to move upon. The pre-slit silicone piston attaches to the lower housing. A series of round protrusions on the inside of the silicone piston provides sliding seals over the long feature on the lower housing. These sliding seals allow fluid to travel through the silicone piston when the piston is accessed with a male luer. The retention ring, made of polycarbonate, fits over the silicone piston and provides extra rigidity. The silicone piston and top housing together comprise the female end of the needle-free valve. The top housing, made of polycarbonate, fits over the top of the piston and is permanently affixed to the bottom housing. When pressed downward by a male luer, the slit in the piston opens, and the sliding seal on the inside of the piston opens a fluid pathway through the device. Silicone oil is used to lubricate the silicone piston. The Arisure™ Neutral Valve does not contain any natural rubber latex.

The provide text is a 510(k) summary for the Arisure™ Neutral Valve. As such, it describes the device's intended use, comparison to predicate devices, and a list of non-clinical tests conducted. The document demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with the detailed parameters requested in the prompt. While non-clinical tests are mentioned, the document does not provide the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert-related details required in the prompt.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document lists non-clinical tests performed (e.g., Microbial Ingress Testing, Liquid Leak, Flow Rate) but does not provide the specific acceptance criteria for each test or the reported performance values. It only states that the testing met "pre-determined acceptance criteria."
• Sample sizes used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a medical device, not an AI/diagnostic study with a "ground truth" derived from expert consensus.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device, not an AI system being evaluated for diagnostic accuracy or human-in-the-loop performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the device, "ground truth" would relate to its physical performance meeting specifications, rather than a diagnostic accuracy truth. The document mentions "hemolytic testing" where "hemolytic percentages below 2% are considered nonhemolytic (ASTM F 756-00)" as a general threshold, but this is a standard, not internally established ground truth from experts.
• The sample size for the training set: Not applicable; this device does not use a training set as it is not an AI/machine learning product.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence to an existing predicate device (MicroCLAVE® Connector and CLAVE® Connector) by comparing technical and performance characteristics and conducting non-clinical tests to ensure safety and effectiveness.

The only specific performance data mentioned related to criteria is about hemolysis:

• Acceptance Criteria for Hemolysis (General Threshold): Hemolytic percentages below 2% are considered nonhemolytic (ASTM F 756-00).
• Reported Device Performance (Hemolysis): Both the 21GA needle (comparator) and the Arisure™ Neutral Valve had hemolytic percentages below 2%. The Arisure™ Neutral Valve had less hemolysis compared to blood withdrawn using a 21GA needle.
• Study Details for Hemolysis (Limited): It was an "additional testing" conducted on the Arisure™ Neutral Valve. Compared to blood withdrawn using a 21GA needle. No sample size, data provenance, ground truth establishment, or expert involvement details are provided for this specific test, beyond the standard mentioned.

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