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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent or medically necessary cases for up to 24 hours.

Insertion sites:

ADULTS (≥22 years old)

• Proximal humerus
• Proximal tibia
• Distal tibia

PEDIATRICS (≤21 years old)

• Proximal humerus
• Proximal tibia
• Distal tibia
• Distal femur

For patients ≥12 years old, use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established.

The EZ-IO Intraosseous Vascular Access System previously cleared with K180395 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

The provided text describes a 510(k) submission for the EZ-IO Intraosseous Vascular Access System. This submission is for a device that already has a predicate (K180395) and the only change is to its MR Safety Status labeling, from "MR Unsafe" to "MR Conditional."

The document does not describe a study involving "AI assistance" or "human readers" or "ground truth established by experts" in the context of diagnostic performance, as the device is a medical access system, not an imaging or diagnostic AI. Therefore, many of the requested points regarding AI/MRMC study details are not applicable to this submission.

However, I can extract information related to the non-clinical testing performed to justify the change in MR safety status.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific update, as the change is primarily about MR compatibility, not a functional performance metric beyond its existing predicate. The "performance" being evaluated is its behavior in an MRI environment.

2. Sample size used for the test set and the data provenance

• Test Article Sample Size: The tests were conducted on the "45 mm needle" as the test article. It's common in such engineering studies to test a representative sample rather than a large clinical cohort. The exact number of 45mm needles tested is not specified, but it's implied to be a sufficient and representative sample for engineering testing.
• Data Provenance: The testing was conducted by "Exponent, 2020," which is a consulting firm specializing in engineering and scientific consulting. The location is not specified, but this is a laboratory/engineering study rather than a clinical data set. It is a prospective test specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is a physical device MR compatibility test, not a diagnostic study requiring human expert interpretation or ground truth establishment in the typical clinical sense. The "ground truth" here is determined by the physical measurements and compliance with engineering standards.

4. Adjudication method for the test set

• Not applicable. This is a physical device test, not a study requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI-assisted diagnostic device study. It is a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an algorithm.

7. The type of ground truth used

• Engineering/Physical Measurements against established safety standards. The "ground truth" for MR compatibility is determined by the quantitative measurements of parameters like RF-induced heating (as per ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 standards) and ensuring these measurements fall within safe limits for MRI environments.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set was involved.

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