(444 days)
The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.
The iNAP One Sleep Therapy System consists of six (6) main components. The components include a console (Model R07-A), a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), soft polymer oral interfaces (iNAP Oral Interface), a Muffler (Optional) and a software application for mobile devices (iNAP Lab+). One additional accessory set (102C) is included, which is a combination of the iNAP Oral Interface and iNAP Tubing Set. The function of iNAP One Sleep Therapy System (Console Model: R07-A) is to develop a negative pressure gradient in user's oral cavity which can be adjusted between -20 to -90 mmHg (-27 to -122 cmH2O) via the App (iNAP Lab+) to achieve or maintain proper vacuum pressure for users.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the iNAP One Sleep Therapy System are primarily focused on its pressure setting range, accuracy, and clinical performance in treating Obstructive Sleep Apnea (OSA). The reported device performance is based on the clinical study described.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adjustable Pressure Range | -20 to -90 mmHg (-27 to -122 cmH2O) |
| Pressure Accuracy | ±5 mmHg (±6.8 cmH2O) |
| Clinical Efficacy for OSA | In a subgroup of 18 subjects treated within the intended pressure range (-20mmHg to -90mmHg): |
- 72.2% (13 subjects) achieved a successful response (treated AHI 50% from baseline and treated AHI 5), baseline AHI, and post-treatment AHI after 28 days of therapy. While PSG is the gold standard for diagnosing OSA and establishing AHI, the document does not specify the number of experts (e.g., sleep specialists, polysomnographic technologists) used to interpret these PSG studies or their specific qualifications.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth from the PSG results. It can be inferred that the PSG interpretations likely followed standard clinical protocols for sleep studies, which inherently involve expert interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any evaluation of human readers improving with AI assistance. The device is a "Sleep Therapy System" that generates negative pressure for OSA treatment, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a physical therapy system, not an algorithm. Therefore, a "standalone algorithm only" performance evaluation, as might be done for an AI diagnostic tool, is not applicable in this context. The clinical study evaluates the performance of the device in use by patients.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's efficacy was established using Polysomnogram (PSG), which is considered the gold standard for diagnosing and quantifying Obstructive Sleep Apnea (OSA). The key metric used was the Apnea-Hypopnea Index (AHI).
8. The Sample Size for the Training Set
The document does not mention the existence of a "training set" in the context of machine learning. The clinical study described is an evaluation of the device's performance after its development, not a study to train an algorithm.
9. How the Ground Truth for the Training Set was Established
As no training set (in the machine learning sense) is mentioned, this question is not applicable. The clinical study serves to demonstrate the safety and effectiveness of the device itself.
§ 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.”