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The OnSite-IV™ is a single use sterile device for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.

The OnSite-IV™ device is a sterile, single use device that, through the use of an integrated vial spike, facilitates creation of a sterile fluid path to transfer liquid from the syringe body to a standard pharmaceutical vial with a 20 mm cap containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the syringe body for delivery into an IV bag or elastomeric pump. The device is intended to be used by health care professionals (HCPs) such as physicians, nurses and pharmacists in a clinical setting.

This is a 510(k) premarket notification for a medical device (OnSite-IV™), not an AI/ML device. As such, the information typically requested regarding acceptance criteria and studies for AI/ML performance (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information) is not applicable here.

This document describes the equivalence of a physical medical device (Intravascular Administration Set) to existing predicate devices based on its design features, intended use, and non-clinical performance testing.

Here's a summary of the non-clinical testing performed and the general acceptance criteria inferred, as best as can be derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria values for each test, but rather confirms that the device "operates as specified" and "functions as intended." The "reported device performance" is a confirmation of passing these tests.

2. Sample size used for the test set and the data provenance
Not applicable as this is a physical device, not an AI/ML system evaluated on a dataset. The testing refers to physical samples of the device. The document does not specify the number of devices or components tested for each non-clinical performance test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert review are concepts for diagnostic performance evaluation of AI/ML systems. This document describes physical and biological performance tests.

4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for human interpretation disagreement in diagnostic performance studies.

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, and no human reader studies are mentioned.

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. The "ground truth" for this device's performance is adherence to established international standards (ISO, ASTM, USP) and internal specifications for physical and biological properties.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

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