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The CytoGuard™ Closed Luer Connector is a bi-directional flow, needle-free, swabable luer access device used as an accessory to an IV Administration Set. It is intended for the administration of parenteral fluids, medication (including hazardous drugs), blood and blood products. With the CytoGuard attached to the standard male luer of a dosing device or container, the CytoGuard valve is in a closed position. Upon connection of its male luer fitting to the female luer fitting of a patient's administration set or catheter, the valve opens to allow medication delivery to the patient. The fluid path then closes, upon disconnect.

CytoGuard is a needle-free, bi-directional flow, luer connector that is swabable, MRI Safe and does not contain PVC, DEHP, or natural rubber latex. The CytoGuard™ Closed Luer Connector is designed to be used by healthcare professionals during medication preparation, admixture, fluid transfer, administration or disposal. Using CytoGuard's female luer end CytoGuard is attached to a dosing device's male luer connector, creating a luer locking connection. With the CytoGuard attached, the dosing device is provided with a closed fluid path due to the presence of the CytoGuard's internal valve. The closed valve helps to reduce inadvertent fluid exposure to patients, clinicians and healthcare personnel.

When the CytoGuard's male luer nut is connected to a standard female luer, the fluid path is opened and allows for the movement of fluid. When the female luer is disconnected from the proposed device, the valve and fluid path closes, preventing the flow of fluid through the CytoGuard.

The female luer end of the CytoGuard possesses a spinning locking feature which will not allow the device to be easily removed, further aiding the reduction of fluid exposure. This feature helps to reduce the risk that the female luer end may inadvertently become disconnected or be removed from the male luer of the dosing device.

To further assist in the appropriate use of the device, the male luer nut has been colored a translucent orange to alert users which end of the device that connections and disconnections can be made. The Instructions for Use references an "orange end" to aid in the easy identification of this part of the device.

The CytoGuard will be available for sale as an individually packaged item and a non luer-activating dust cover cap to prevent touch contamination is provided as a separately sold accessory for the CytoGuard for use during transport.

The provided text describes a medical device submission (K112636) for the CytoGuard™ Closed Luer Connector, not an AI/ML powered device. Therefore, a direct comparison of acceptance criteria and reported device performance in the context of AI is not applicable. The document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices through various performance tests.

However, I can extract the information related to the device's performance testing and intended functionalities, which can be interpreted as fulfilling certain "acceptance criteria" for a medical device.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

Since this is a non-AI/ML device, the concept of "acceptance criteria" is more about demonstrating functional equivalence and safety rather than a performance metric like accuracy or AUC.

Study Proving Acceptance Criteria:

The document states:

"Therefore, performance testing has been conducted. In addition, testing was performed to support an expanded variety of usage conditions of the CytoGuard. Several different fluids were evaluated for compatibility, including blood, general IV fluids, and chemicals identified on the "NIOSH Alert" drugs list, publication number 2004-165 dated September 2004 which is provided within this submission."

"Functional performance testing, a simulated clinical use study, and testing of the locking feature and colored design features of the proposed device, have each demonstrated that the CytoGuard Closed Luer Connector does not raise new issues of safety or effectiveness."

2. Sample sized used for the test set and the data provenance:

The document mentions "performance testing" and a "simulated clinical use study," but does not specify the sample sizes for these tests or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical medical device, not an AI/ML system requiring human expert ground truth for image or data interpretation. The "ground truth" for its performance is derived from physical testing against established standards and predicate device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This device is a physical medical device and does not involve subjective interpretations requiring adjudication of expert opinions.

5. 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. This device is a physical medical device and is not an AI-assisted diagnostic or decision-support tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The ground truth for this device's performance is established through physical and functional testing against predefined engineering and medical device standards, comparative testing with predicate devices, and potentially some in-vitro or simulated clinical environment performance verification. The document mentions compatibility with various fluids, implying testing against the physical properties and interaction of these fluids with the device components.

8. The sample size for the training set:

Not applicable. This is a manufactured physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set for an AI/ML model is involved.

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