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EZ-MIO and EZ-IO: The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia of adults when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

Vidaport Intraosseous Infusion System: The VidaPort provides intraosseous access in the proximal tibia, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in adult patients only.

EZ-IO Humeral Head: The Humeral Head EZ-IO provides intraosseous access in the Humeral Head, when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.

The EZ-MIO manual driver and EZ-IO power driver provide intraosseous access in the distal tibia. The VidaPort provides intraosseous access in the proximal tibia. The EZ-IO Humeral Head provides intraosseous access in the Humeral Head. These devices are used when intravenous access is difficult or impossible to obtain.

The provided text is a 510(k) summary for the Vidacare® Needle for EZ-MIO and EZ-IO, Vidaport Intraosseous Infusion System, and EZ-IO Humeral Head. This document does not contain information about acceptance criteria or a study proving device performance in the manner requested. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.

The key points from the document are:

• Device: Intraosseous infusion systems (needles and drivers) for providing access in the distal tibia, proximal tibia, or humeral head.
• Purpose of Submission: Extends the indications for use to include usage for up to 24 hours.
• Method of Equivalence: The submission states, "There have been no changes to the design or components of the devices cleared under 510(k) K062956, K032885 and K052408, and therefore the comparison of technological characteristics listed below are identical." This means the product's performance is assumed to be equivalent to the predicate devices because its design and components are unchanged.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies because the provided text does not contain that information. The document is a regulatory submission focused on substantial equivalence, not a detailed performance study report.

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