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The SmartSite® Stopcock is indicated for fluid flow, directional control and for providing access port(s) for administration of solutions and blood products. Typical uses include pressure monitoring, intravenous fluid administration and transfusion. The SmartSite® valve port allows the user to access the primary line without the use of a needle.

The SmartSite® Stopcock is a single use 4-way stopcock with an integrated SmartSite® needle free valve on the side port. Arrows on the handle point to the direction of flow. The side port consists of a SmartSite® needle free valve that provides closed, needle-free access that seals upon removal and does not require re-capping between uses. The SmartSite® Stopcock share similar characteristics and will operate the same as currently marketed stopcocks, as an accessory to an IV administration set that regulates the directional flow to a patient's vascular system and provides an access port(s) for the administration of solutions.

This document is a 510(k) summary for the Cardinal Health, Alaris® Products® SMARTSITE® STOPCOCK. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed performance data or study results typically found in an academic paper or a more comprehensive technical report that would directly answer your questions about acceptance criteria and how a study proves those criteria are met for an AI/ML device.

This submission is for a medical device (a stopcock) used in intravenous administration, not for an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and effect sizes of AI assistance, are not applicable to this document. The "performance data" section in {3} merely states that the device "meets specified requirements" and is "substantially equivalent to the predicate devices" without detailing the specific criteria or the studies conducted.

To directly answer your request based on the provided text, the following information is available:

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

The document does not explicitly list acceptance criteria in a quantitative table format or detailed performance results. Instead, it makes a general statement:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable or not provided. This is a traditional medical device submission, not an AI/ML device, and no specific test set sample size or data provenance details are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable or not provided. This is a traditional medical device submission, not an AI/ML device, and no expert ground truth establishment is described.

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

Not applicable or not provided.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable or not provided. The substantial equivalence is based on technological characteristics and functional performance compared to predicate devices, rather than a "ground truth" in the AI/ML sense.

8. The sample size for the training set

Not applicable or not provided. This is not an AI/ML device.

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

Not applicable or not provided. This is not an AI/ML device.

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