Search Results

Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS (Respiratory Distress Syndrome). May or may not include humidification capabilities.

The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients

The provided text describes the "Guardian Neonatal CPAP / Humidification System" and confirms its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it include details typically found in performance studies for medical devices like sample sizes, ground truth establishment, or expert involvement.

The document is a "Summary of Safety and Effectiveness" (510(k) summary) and an FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting raw performance data or detailed study results against specific acceptance criteria. The "Measured Data" section lists ranges for various parameters but doesn't present them as acceptance criteria or performance results from a study.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. I can only report on what is explicitly stated.

Ask a specific question about this device

The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.

The Infant Flow Plus System is a factory-installed modification to the Infant Flow Plus System. It uses the existing manually operated air / oxygen mixer and CPAP flow control. An ancillary manual flow control with electronic control solenoid valve allows timed delivery of augmented flow and pressure. The modification is housed in a robust enclosure that is designed to "piggy back" on to the existing Infant Flow Driver Unit.

The provided text describes a 510(k) premarket notification for the Infant Flow Plus System. This is a medical device and the performance data presented is related to its compliance with safety and electrical standards, not the clinical performance of an AI/ML algorithm.

Therefore, many of the requested categories in the prompt (e.g., acceptance criteria for an AI algorithm, sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth for AI, etc.) are not applicable to this document. This document outlines the regulatory approval for a physical medical device.

However, I can extract the information relevant to the device's performance based on the standards it complies with.

Here's a summary of the available information:

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

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

• Not applicable. This document describes compliance with device safety and functional standards, not a clinical study involving a test set of patient data.

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

• Not applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for these standards would be the specifications and requirements defined by the standards themselves, validated through engineering tests.

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

• Not applicable. No adjudication method for a test set of patient data is mentioned as it's not a clinical study. Compliance with standards is typically verified through documented testing and review processes by qualified engineers and regulatory bodies.

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 device is an Infant Flow Plus System, a bi-level CPAP system, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.

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

• Not applicable. This refers to an AI/ML algorithm's performance. The Infant Flow Plus System is a physical medical device.

7. The type of ground truth used:

• Not applicable in the AI/ML sense. For the device itself, the "ground truth" for its performance is its adherence to the technical specifications and safety requirements outlined in the cited IEC and UL standards.

8. The sample size for the training set:

• Not applicable. There is no AI/ML training set mentioned in this document.

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

• Not applicable. There is no AI/ML training set mentioned in this document.

Ask a specific question about this device