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The Powered PD-IO provides intraosseous access in the distal tibia of pediatric patients as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours.

The Humeral Head EZ-IO provides vascular access when standard venous access is not possible. Humeral head IO access is indicated in pediatrics in emergent, urgent, or medically necessary cases when intravenous access is difficult or impossible to obtain for up to 24 hours.

The Powered PD-IO Intraosseous Infusion System provides intraosseous access in the proximal tibia as an alternative to IV access in emergent, urgent, or medically necessary cases for up to 24 hours. The device is for use in pediatric patients (approximate weight range: 3kg-39kg).

This submission seeks to extend the indications for use for the Powered PD-IO Intraosseous Infusion System (K051992); EZ-IO Humeral Head (K052408) and Powered PD-IO (K063142) for emergent, urgent and medically necessary intraosseous vascular access for the delivery of drugs and fluids to pediatric patients. Vidacare manufactures all of these products. The expansion of indications for these products requires no new technology to facilitate the safe application of the product. There have been no changes to the design or components of the devices cleared under 510(k) K051992, K052408, K063142 and therefore the comparison of technological characteristics listed below are identical.

I am sorry, but the provided text is a 510(k) summary and FDA clearance letter for a medical device (Powered PD-IO Intraosseous Infusion System). This type of document describes the device, its intended use, and its substantial equivalence to previously cleared devices.

It does not contain information about acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, ground truth establishment, adjudication methods), multi-reader multi-case (MRMC) studies, or standalone algorithm performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is focused on regulatory clearance based on equivalence, not on detailed performance studies of the kind you are asking about.

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