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The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.

The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.

The provided 510(k) summary for "The WAND™ MicroAccess Safety Introducer" does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered system. The document describes a traditional medical device (catheter introducer) and its premarket notification rather than an AI/ML diagnostic or assistive device.

Therefore, I cannot extract the requested information such as test set sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, or how ground truth for training was established, as these concepts are not relevant to the described device and its regulatory submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and in vitro bench testing. It does not involve AI or algorithms that would require evaluation against clinical performance metrics like sensitivity, specificity, or reader improvement.

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