Search Results

The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb). The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.

The Puffin Lite Infant Resuscitation System underwent bench testing to demonstrate conformance to performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual bench test. The testing was described as "bench testing," which typically involves laboratory-controlled environments and simulated conditions rather than real patient data. The data provenance is from this bench testing, not from human subjects or real-world clinical data. Therefore, there is no information on country of origin or whether the data was retrospective or prospective.

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

This information is not applicable. The study involved bench testing of a medical device, where acceptance criteria were based on engineering and performance specifications (e.g., pressure, flow, FIO2 accuracy) rather than expert interpretation of medical images or data. Ground truth was established by measuring the physical performance parameters of the device against predefined technical requirements.

4. Adjudication method for the test set:

Not applicable. As the study was bench testing against predefined technical specifications, there was no need for an adjudication method by human experts for the "ground truth." The "passing" or "failing" of a test was determined by whether the device's measured performance fell within the specified limits.

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 510(k) submission for a physical medical device (infant resuscitator) and not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This device is not an algorithm or an AI system. It is a physical medical device (infant resuscitator) that is intended for use by trained medical professionals.

7. The type of ground truth used:

The ground truth used for this study was the engineering and performance specifications outlined in the acceptance criteria. The device's performance was measured against these objective, predefined technical requirements. There was no reliance on expert consensus, pathology, or outcomes data in the context of this bench testing.

8. The sample size for the training set:

Not applicable. This device is not an AI or machine learning system that requires a "training set" of data.

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

Not applicable, as there was no training set for this device.

Ask a specific question about this device