(213 days)
The ReddyPort NIV Access Elbow is intended to provide an interface for application of CPAP or bi-level therapy. The elbow is for single patient use in the hospital/institutional environment. The elbow is to be used on patients 7 years or older (>40lbs/18.2kg) for whom CPAP or bi-level therapy has been prescribed.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to SMD Manufacturing, LLC, regarding the ReddyPort NIV Access Elbow. This document is a regulatory communication for a medical device and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for AI/algorithm-based devices.
Therefore, I cannot extract the requested information as it is not present in the provided text. The device described, the "ReddyPort NIV Access Elbow," is a physical medical device (an elbow interface for CPAP/bi-level therapy), not an AI or algorithm-based device that would typically undergo the kind of performance studies you're asking about with specific acceptance criteria, test sets, ground truth, and expert adjudication.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory classification for certain medical devices, and outlines general controls and regulations it is subject to.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).