(133 days)
The OPAP ® device is an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea. This device is indicated for use with CPAP and Bilevel systems. The OPAP Of facilitated delivery of or CPAP and Bilevel is similar to nasal mask CPAP and Bilevel. Individual patients and specific problems may or may not be treated more effectively with the OPAP C. Consult your sleep physician or dentist.
an individually molded mandibular repositioner mouthpiece / appliance that has an airway lumen and an integral oral chamber and exhaust port which facilitates application of positive airway pressure to treat obstructive sleep apnea.
This document is a 510(k) clearance letter from the FDA for a medical device called OPAP®. It does not contain information about acceptance criteria or a study proving device performance in the context of the requested details (AI/ML performance, ground truth, sample sizes, etc.). The letter primarily states that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is regulatory correspondence, not a study report or clinical trial documentation.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).