(147 days)
The Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors) amplifier is intented for use with Pro-Tech G inchrony or the censure during steep directed ing, belancing, summing and an effort 5%
Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors)
The provided document is a 510(k) clearance letter from the FDA for a medical device (Quantum-Synchrony Respiratory Effort System). This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and grants permission to market it. It typically does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria, such as performance metrics, sample sizes, expert qualifications, or ground truth establishment. These details are usually found in the 510(k) submission itself, which is not provided here.
Therefore,Based on the provided text, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them. The document is an FDA clearance letter and does not contain the detailed technical specifications or study results you are asking for. It confirms the device's substantial equivalence to a predicate device but does not elaborate on the performance data or methodology from the original submission.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).