(45 days)
The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).
The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.
The provided 510(k) summary for K090398, "PROVENT™ Professional Sleep Apnea Therapy – 50 cm H2O sec/liter", does not contain the detailed information requested regarding acceptance criteria, study design for device performance, or human-in-the-loop studies.
Instead, the summary states:
"Non-clinical and clinical testing demonstrated substantial equivalence of the PROVENT 50 device to the predicate device when used according to its intended use."
This indicates that the submission relied on demonstrating the new device (PROVENT 50) was substantially equivalent to a previously cleared predicate device (Provent™ Professional Sleep Apnea Therapy, K071560), rather than presenting new, detailed performance study data against specific quantitative acceptance criteria or evaluating AI components. Since this device is not an AI/ML powered device, the questions regarding multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for AI models are not applicable.
Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically provides a high-level overview and does not always include the exhaustive details of performance studies that would be found in the full 510(k) submission.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”