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The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.

The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. A manual resuscitator is a resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible unit of the device, the ventilation bag. The ventilation bag is self-inflating: the compressed bag will refill with ambient air via the bag inlet valve. The resuscitator provides positive pressure ventilation of the lungs (when used with a face mask). The resuscitator can be used to provide supplemental oxygen when used with the oxygen kit, the NeoNatalie Resuscitator Oxygen Kit. When a resuscitator fitted with an oxygen reservoir is used to provide supplemental oxygen, the ventilation bag will refill with oxygen from the oxygen reservoir. The NeoNatalie Resuscitator is made of polysulfone, silicone rubber and stainless steel. The NeoNatalie Resuscitator is reusable resuscitator which may be sterilized by autoclaving.

The provided text describes the regulatory clearance for the NeoNatalie Resuscitator and includes a comparison to a predicate device, as well as general information about testing performed. However, it does not contain the detailed clinical study information typically provided when discussing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device.

The NeoNatalie Resuscitator is a mechanical medical device (manual resuscitator), not an AI/ML device, and therefore the specific questions regarding test sets, training sets, ground truth, expert adjudication, and MRMC studies are not directly applicable in the way they would be for an AI/ML diagnostic or predictive tool.

Based on the provided text, here's an attempt to answer the questions, highlighting where the information is not directly available or applicable:

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

The document frames the "acceptance criteria" and "device performance" in terms of compliance with international standards and functional requirements for a manual resuscitator, rather than traditional clinical performance metrics like sensitivity or specificity for an AI algorithm.

Note: The document states "Design verification and design validation testing demonstrates that the NeoNatalie Resuscitator meets its functional requirements and performance specifications." The table above reflects specific quantitative metrics provided and general statements about compliance with standards.

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

This information is not provided in the document. For a mechanical device, "test set" typically refers to physical units or simulated environments rather than patient data. The testing mentioned appears to be laboratory-based design verification and validation.

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)

This information is not applicable and therefore not provided. The testing relates to engineering and material performance, not expert-derived ground truth for an interpretive task.

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

This information is not applicable and therefore not provided. Adjudication methods are relevant for subjective interpretations, often in clinical studies or AI ground truth establishment.

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

This information is not applicable and therefore not provided. MRMC studies are used to evaluate the performance of diagnostic systems, often AI-assisted, and are not relevant for a manual mechanical resuscitator.

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

This information is not applicable and therefore not provided. This device is a manual resuscitator and does not involve an algorithm. Its operation inherently involves a "human-in-the-loop" as it is "operator-powered."

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

The "ground truth" for this device's performance is compliance with established engineering standards (e.g., ISO 10651-4:2002 for lung ventilators, ISO 5356-1:2004 for conical connectors) and functional specifications (e.g., specific resistance values, dead space, biocompatibility). It is determined by objective physical measurements and established test protocols, not clinical outcomes data, pathology, or expert consensus in an interpretive sense.

8. The sample size for the training set

This information is not applicable and therefore not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable and therefore not provided. There is no "training set" for this device.

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