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Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter inserted into a vein.

Universal Spikes are used to build Intravascular Administration Sets which are Single Use, sterile, non- pyrogenic device and provides access for the administration of fluids from a controliner to a patient's vascular system through the administration set's needle or catheter inserted into a ven. Each set will be manufactured to unique specifications using dimensions, components, and configurations specified by the customer. Standard sets will also be offered. Components used in the IV sets may be either manufactured by ICU medical or purchased from other manufacturers. Components will be assembled into configurations specified by the customer and packaged.

The provided text is a 510(k) summary for the ICU Medical Universal Single-Use Spikes. It states that the device is substantially equivalent to a predicate device (K964435 - IV Sets- ICU Medical, Inc.) based on having the same intended use and materials.

However, the document does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone).

The document focuses on establishing substantial equivalence for regulatory purposes rather than describing a detailed performance study with acceptance criteria. It mentions "Safety and Performance" and states that "ICU Medical Universal Single-Use Spikes conform to the requirements of published international standards as well as those FDA recognized standards and/or published guidelines prior to marketing the device." This implies adherence to general standards relevant to such medical devices, but it does not specify quantitative acceptance criteria or the studies used to demonstrate compliance to them in this document.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

This information is typically found in detailed testing reports, design validation documentation, or other sections of a 510(k) submission, but it is not present in the provided "Summary of Safety and Effectiveness."

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