(47 days)
The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg).
Not Found
This document is a 510(k) premarket notification from the FDA for a medical device called the "Ambu® SPUR® II Adult Single Patient Use Resuscitator." This type of document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. This substantial equivalence is assessed based on design, materials, and intended use, rather than a detailed performance study with acceptance criteria and ground truth as would be reported for an AI/ML diagnostic device.
Therefore, I cannot provide the requested table and information based on the provided text.
§ 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).