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The NIO is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

The NIO is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required, and intravenous access is not possible. The device is for use in adult patients only.

The Adult NIO permits intraosseous access through the Proximal Tibia and the Humeral Head.

The NIO device is comprised of a trocar needle, spring, piston and housing and it resembles a syringe. When activated, a loaded spring is released, and the device injects the needle to a predetermined depth into the bone marrow cavity.

This document is a 510(k) Premarket Notification from the FDA regarding an "Adult Intraosseous infusion device" (K182770). It explicitly states that no performance testing (clinical or non-clinical) was required or submitted to prove the device meets acceptance criteria.

The basis for substantial equivalence is that the Einstein Works, L.L.C. Adult Intraosseous infusion device (NIO) is identical to the legally marketed predicate device, WaisMed LTD NIO-A Intraosseous Infusion Device (K142086), in terms of intended use, technological characteristics, design, components, and safety mechanisms.

Therefore, your request for acceptance criteria and study details cannot be fully answered from the provided text, as such information was not part of this 510(k) submission.

Here's what can be extracted based on the document's content:

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

The document states:

• "Performance data were not required to determine substantial equivalence."
• "There are no clinical data submitted with this Notification."

Therefore, no acceptance criteria or reported device performance are provided in this document as they were not a requirement for this specific 510(k) clearance due to the device being identical to a previously cleared predicate. The "performance" in this context refers to the device being functionally identical to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No test set data of this nature were submitted or required for this 510(k) notification. The substantial equivalence was based on direct comparison to an existing device rather than new performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No test set requiring expert ground truth was performed or submitted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring adjudication was performed or submitted.

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

• Not applicable. This is a medical device (intraosseous infusion device), not an AI-assisted diagnostic tool. No MRMC studies were conducted or relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was the established characteristics and performance of the legally marketed predicate device (WaisMed LTD NIO-A Intraosseous Infusion Device, K142086). The applicant asserted and the FDA confirmed that their device was identical to this predicate.

8. The sample size for the training set

• Not applicable. No training set was used as no new algorithm development or clinical performance testing was conducted.

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

• Not applicable. No training set was used.

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