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The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (

The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.

The provided text describes a medical device, the "Mini-Midline™ Extended Dwell Safety Catheter," and its substantial equivalence to predicate devices, but does not include acceptance criteria for a study demonstrating AI/algorithm performance. The document focuses on regulatory approval (510(k) submission) for a physical medical device, not a software algorithm.

Therefore, most of the requested information regarding AI/algorithm performance (acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, MRMC studies, standalone performance) cannot be extracted from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not present for an AI/algorithm-based device. The document lists "Technical Characteristics" and "Performance Data" for the physical catheter.

However, the document does list technical characteristics and performance data for the physical device:

Technical Characteristics and Performance Data (for the physical catheter):

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