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The NIO-I is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.

The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age. The NIO-I provides haptic feedback via the steppedneedle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.

The provided text is a 510(k) summary for the NIO-I intraosseous device, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate, often without the need for new clinical trials if technological characteristics and indications for use are substantially similar.

The document explicitly states: "No clinical Study is included in this submission." This means that the information typically found in a clinical study report (such as sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance) for a new device's performance against acceptance criteria in a clinical setting will not be present in this document.

Instead, the submission relies on:

• Comparison to a predicate device: The core argument for substantial equivalence is that the NIO-I is technologically identical and shares the same indications for use as the previously cleared Waismed LTD's NIO-I (K190538).
• Non-clinical performance testing: This includes biocompatibility testing, mechanical property tests, and compliance with various international standards. These tests demonstrate the device's physical and biological safety and performance characteristics, but not its clinical effectiveness in human subjects or its performance in an AI/imaging context.

Therefore, I cannot extract the requested information (acceptance criteria for clinical performance, details of a study proving device meets acceptance criteria, sample sizes, ground truth adjudication, MRMC studies, standalone performance, training set details) from this document because it explicitly states that no clinical study was performed or included in the submission.

The acceptance criteria described in this document are primarily for non-clinical performance and biocompatibility, demonstrating that the device meets engineering specifications and safety standards for the materials and design, aligning with the predicate device.

Here's the information that can be extracted from the provided text, primarily related to the device comparison and non-clinical testing:

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

Based on the document, the "acceptance criteria" are implied by compliance with specific standards and successful completion of internal V&V tests, aiming to demonstrate substantial equivalence to the predicate. No explicit numerical acceptance criteria (e.g., "accuracy > X%") for clinical performance are stated, as no clinical study was performed.

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 for clinical data. The submission explicitly states, "No clinical Study is included in this submission."
• For non-clinical tests (e.g., mechanical tests, biocompatibility), the document refers to "internal V&V tests plan" and compliance with standards, which would imply a number of samples tested per the specific standard requirements and validation protocols. However, the exact sample sizes for each non-clinical test are not specified in this summary. Data provenance for non-clinical tests is generally from the manufacturer's lab or contracted testing facilities.

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

• Not applicable. No clinical study was performed or included where expert human review would be establishing ground truth for a test set. This device is not an AI/imaging device requiring expert interpretation.

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

• Not applicable. No clinical study was performed or included.

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 needle), not an AI-assisted diagnostic imaging product. No MRMC study was conducted or is 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 clinical ground truth. For non-clinical performance, "ground truth" is defined by compliance with established engineering and biocompatibility standards (e.g., ISO, ASTM), and the device's characteristics being identical to the predicate.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.

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

• Not applicable. This is a physical medical device.

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