(106 days)
The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.
This is a prescription device.
The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
This document is a 510(k) summary for the NeoPEEP Neonatal Resuscitation Circuit with PEEP. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device evaluation is not explicitly available in this document.
However, based on the provided text, we can infer some information relevant to the device's functional performance:
- Device Description: The NeoPEEP Neonatal Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
- Intended Use: The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.
- Predicate Device: The substantial equivalence claim is based on comparison to the Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP. This suggests that the performance characteristics of the NeoPEEP would be expected to be similar to this predicate device.
Given that this is a 510(k) submission for a non-AI medical device, the typical "study" proving acceptance criteria involves demonstrating that the device meets established safety and performance standards for its class and is substantially equivalent to a legally marketed predicate device. This usually involves engineering testing, biocompatibility assessments, and performance verification to ensure it functions as intended and safely. The document does not describe a clinical trial or a study with a test set, ground truth, or expert review in the manner one would for an AI diagnostic device.
Here's an attempt to answer the questions based on the available information, noting where the information is not provided:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria and reported device performance is present in the provided text. The document's primary purpose is to establish substantial equivalence to a predicate device based on "intended use, design, operational and technological characteristics, and principles of operation." This implies that the device is expected to perform comparably to the predicate device in delivering positive end expiratory pressure during neonatal resuscitation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document pertains to a hardware medical device (resuscitation circuit) and does not describe a clinical study with a test set of data (e.g., images, patient records) or data provenance in the context of an AI algorithm.
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. Ground truth and expert review in this context would typically refer to the validation of a diagnostic AI device, which is not what this submission is about.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in this document.
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 not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" might refer to engineering specifications or regulatory standards for pressure delivery and safety, but it's not discussed in terms of clinical outcomes or expert review in the text.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).