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The Fountain Infusion Catheter and Occluding Guide Wire will be used for the infusion of various therapeutic drugs into the peripheral vasculature of a patient.

The Fountain 104 Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

The Fountain™ Infusion Catheter has infusion holes at the distal end. The infusion holes are located at many locations around the catheter. The infusion segment of the catheter is indicated by two radiopaque marker bands.

The Occluding Guide Wire occludes the distal end of the Fountain Infusion Catheter. The proximal end of the occluding wire has a marker for verification of proper placement.

The provided FDA 510(k) summary for the "Fountain Infusion Catheter and Occluding Guide Wire" does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/algorithm-based devices.

This document is a 510(k) premarket notification for a physical medical device (a catheter and guide wire). The content focuses on demonstrating substantial equivalence to a predicate device based on device description, intended use, and general characteristics, rather than on performance metrics of an AI algorithm.

Therefore, I cannot fulfill the request to provide:

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

These elements are relevant for the evaluation of AI/Machine Learning-enabled medical devices, where performance is often measured by diagnostic accuracy, sensitivity, specificity, etc., against a ground truth established by experts or pathology. The document provided describes a catheter and guide wire, for which performance would typically be evaluated through bench testing (e.g., flow rates, material compatibility), animal studies, and potentially human clinical trials for safety and efficacy in delivering therapeutic agents, but not in the format requested for AI device validation.

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