Search Results

The NeoPIP Infant Resuscitator with Flow Meter is a manually operated, gas powered device with integrated flow meter intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.

The NeoPIP Infant Resuscitator with Flow Meter is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.

The provided text is a 510(k) summary for the NeoPIP Infant Resuscitator with Flow Meter. The document focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving specific acceptance criteria for device performance as would be expected for an AI/ML powered device.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not available in the provided text. The document primarily describes the device, its intended use, classification, and asserts substantial equivalence to existing devices.

Here's an analysis based on the information provided, highlighting what is implicitly or explicitly stated and what is missing:

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

The document does not explicitly state acceptance criteria or a detailed performance report in the format of a table. The "Performance Standards" section explicitly states "None applicable." The premise of the 510(k) summary is to demonstrate substantial equivalence, meaning its performance should be comparable to the predicate devices, rather than meeting specific quantifiable performance metrics.

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

The document does not describe a test set, sample size, or data provenance as it would for an AI/ML powered device. The 510(k) is a marketing clearance application for a medical device (a resuscitator), and the "study" demonstrating its safety and effectiveness relies on comparison to predicate devices, not on a data-driven performance study.

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. The document does not describe a test set or the establishment of a ground truth by experts. Substantial equivalence relies on engineering and functional comparisons, not expert-adjudicated datasets.

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

Not applicable. There is no test set or adjudication process described.

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. The device is a "manual emergency ventilator" (resuscitator), not an AI/ML-powered diagnostic or assistive tool for human readers. There would be no MRMC study in this context.

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

Not applicable. The device is a physical, manually-operated medical device, not an algorithm.

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

Not applicable. The concept of "ground truth" as used in AI/ML performance evaluation is not relevant for this device. The safety and effectiveness are established through design, manufacturing controls, and comparison to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.

In summary: The provided 510(k) summary is for a traditional mechanical medical device, not an AI/ML-powered one. Therefore, the questions related to acceptance criteria for AI performance, test sets, experts, and ground truth are not addressed in this type of document. The entire document serves as a demonstration of "substantial equivalence" of the NeoPIP Infant Resuscitator with Flow Meter to legally marketed predicate devices in terms of intended use, safety, and effectiveness.

Ask a specific question about this device