(183 days)
The manual resuscitator is intended for use on patients requiring total or intermittent airway support. Provides positive pressure ventilation and allows spontaneous breathing either with a 22mm inner diameter face mask port or through an artificial airway having a 15mm outer diameter connection.
The Rusch Manual Resuscitator is intended for manual ventilation of patients with air or air enriched oxygen The resuscitator is manufactured as either an adult, pediatric, or infant model, intended to treat an adult child, or infant respectively
The product consists of a face mask, bag, valve, reservoir bag, and tubing with connector for introduction of oxygen enriched air. The valve is made from K-Resin and the other main components mentioned above are made from PVC. The cushion mask is clear to permit easy patient monitoring and is mounted on a 360° swivel for convenience. The bag is textured to give a positive grip.
This document is a 510(k) summary for a medical device (Rusch Manual Resuscitator Bag), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert reviews.
Therefore, many of the requested elements regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted from the provided text. The document is essentially a regulatory submission, not a scientific study report.
Here's an analysis based on the information provided in the extract:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission aims to prove substantial equivalence based on design, construction, and intended use, rather than quantitative performance against specific criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No performance study or test set data is described. The submission focuses on device description and comparison to a predicate.
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)
No experts were used to establish ground truth for a test set, as no such test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is mentioned as there is no described test set or expert review process.
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
No MRMC study was done, nor is there any mention of AI assistance. This device is a manual resuscitator bag.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No ground truth data (in the context of a performance study) is mentioned. The ground for substantial equivalence is based on comparison to a legally marketed predicate device.
8. The sample size for the training set
No training set is mentioned.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).