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The PROVENT® Sleep Apnea Therapy Device is indicated for use in 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 text is a 510(k) summary for the PROVENT® Sleep Apnea Therapy device. It contains regulatory information, device description, and indications for use, but it does not contain any performance data, acceptance criteria, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested information in the format requested. The document explicitly states:

"Non-clinical and clinical testing demonstrated substantial equivalence of the modified devices to the predicate devices when used according to the intended use."

However, it does not present the results of these tests, define "acceptance criteria," or elaborate on the study design (sample size, ground truth, expert qualifications, etc.).

To answer your request, I would need a different document that details the specific performance data and the study conducted to demonstrate that the PROVENT® Sleep Apnea Therapy device meets its acceptance criteria.

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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.

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