(246 days)
The Provent™ Professional 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 describes a 510(k) submission for the Provent™ Professional Sleep Apnea Therapy device. While it mentions that "Bench and clinical performance data were submitted to support the 510(k) Notification" and that "The bench and clinical testing demonstrated that the device is safe and effective for its intended use," it does not provide specific acceptance criteria or details of the study that proves the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use, product codes, mechanism of action, and other general characteristics.
Therefore, I cannot populate the requested table and information based on the provided text.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance thresholds are mentioned.
- Sample sized used for the test set and the data provenance: No details on the number of patients/subjects, their demographics, or where the data came from (e.g., country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of expert involvement or ground truth establishment for a test set.
- Adjudication method: Not applicable as no expert review process is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a therapeutic device, not an AI-powered diagnostic tool, so an MRMC study is not relevant in this context.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical therapeutic device.
- The type of ground truth used: No ground truth is mentioned.
- The sample size for the training set: This refers to a machine learning context, which is not applicable here.
- How the ground truth for the training set was established: Not applicable.
§ 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.”