(88 days)
OptiPillows EPAP Mask is intended for use during sleep to alleviate snoring. It is intended for the adult population with snoring only.
OptiPillows EPAP mask is a nasal dilator device for alleviation of snoring. The EPAP mask is a reusable device. The EPAP mask has nasal pillows that fit against the nostrils similar to the ones used in several nasal pillow CPAP masks. The EPAP mask has a one-way valve attached to it that allows air to flow freely without resistance during inspiration. The mask is held in place with adjustable head straps connected to the sides of the mask. During expiration, the air is redirected through a narrow opening, on the side of the expiratory opening creates resistance to airflow, thus increasing the back pressure in the nose, mouth, and upper airways. The increase in back pressure during expiration prevents the collapse of the upper airways, alleviating airway obstruction. The level of back pressure can be adjusted to the patient comfort by turning a rotating sleeve/collar to open or close the expiratory opening on the side of the valve. The adjustable expiratory resistance improves the comfort and safety for the user and facilitates adaptation to the EPAP mask.
The EPAP mask is a small device and is used like a CPAP mask, but does not require using a power supply, a CPAP machine or tubing that restricts movement of the patient during sleep.
The provided text is a 510(k) summary for the OptiPillows EPAP Mask, which is a nasal dilator device intended for use during sleep to alleviate snoring. However, the document does not contain specific acceptance criteria tables or a detailed study plan that measures performance against predefined quantitative metrics suitable for a typical AI/ML medical device submission.
Instead, this submission is for a physical medical device (a nasal dilator) and focuses on demonstrating substantial equivalence to a predicate device (InVent Snoring Device) based on intended use, principle of operation, material biocompatibility, and general safety. The "clinical study" described is more of a user feedback and usability assessment rather than a traditional clinical trial with a defined test set, ground truth experts, and statistical performance metrics.
Therefore, many of the requested details about acceptance criteria, test set specifics, expert qualifications, and comparison with AI/ML-based studies cannot be extracted directly from this document.
However, I will extract what information is available and indicate when information is not present in the document.
Description of Device and Purpose of Study
The OptiPillows EPAP Mask is a reusable nasal dilator device intended for use during sleep to alleviate snoring in adults. It works by creating positive pressure during expiration through a resistance valve, preventing the collapse of upper airways. The "study" described is primarily a user feedback and usability assessment to support the device's safety and effectiveness claim through substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a formal table of quantitative acceptance criteria with corresponding performance metrics like those typically seen for AI/ML device submissions (e.g., sensitivity, specificity, AUC). The "acceptance" here primarily relies on qualitative user feedback, observed usability, and demonstration of comparable mechanism of action to a predicate device.
| Aspect of Performance/Criteria | Reported Device Performance (Summary from clinical questionnaire feedback) |
|---|---|
| User Friendliness | "The EPAP mask is user friendly, easy to use, and safe." |
| Snoring Improvement | "Users, with the help of their bed partners, also reported feeling an improvement in their snoring." |
| Safety/Adverse Events | "There were no concerns expressed by the users about the safety of the EPAP mask and there were no reports of any adverse events among the patients who responded to the survey other than having difficulty falling asleep during the first week of using the EPAP mask." |
| Patient Adaptation | "The EPAP mask is well liked by many patients after an initial one week orientation period, but may not be ideal for every user; some just cannot get used to it and refuse to use it." |
| Daytime Functioning (ESS Score) | "The device also helped to some extent in improving daytime functioning after 1-2 months use, as seen by the slight decrease in daytime sleepiness score as measured using the Epworth Sleepiness Scale (8.7±0.7 to 6.2±1.2)." (Note: Minimal clinically important difference for ESS is -2 to -3). |
| Biocompatibility | No concern in terms of material safety, toxicity, or risks. Materials are standard medical grade and have been time tested. |
| Shelf Life/Reuse | Supported 6-month shelf life. No significant visual or material degradation; performance not affected after accelerated aging. Can be cleaned daily without degradation. |
| Expiratory Resistance | Performance testing showed pressure generated is "substantially equivalent" to predicate device over available range. Adjustable resistance allows patient comfort and adaptation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Questionnaire/User Feedback):
- Group 1 (Existing Users): 39 questionnaires provided, 29 responded (21 men, 8 women).
- Group 2 (New Users): 18 patients, 13 responded and completed questionnaires (4 females, 9 males).
- Total Responded: 29 + 13 = 42 patients.
- Data Provenance: The document does not explicitly state the country of origin. Given the "Phoenix, Arizona" address for the submitter, it is implied the users were likely from the US.
- Retrospective or Prospective:
- Group 1: Retrospective (patients already using the mask for >6 months).
- Group 2: Prospective (new patients trying the mask, followed for 30-60 days).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable (N/A) in the context of an AI/ML device.
This submission is for a physical mechanical device. The "ground truth" for snoring alleviation and usability was primarily based on self-reported user feedback and bed-partner observations, documented via questionnaires. There were no "experts" in the sense of radiologists adjudicating images or clinicians diagnosing conditions for a test set. The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire.
4. Adjudication Method for the Test Set
N/A in the context of an AI/ML device.
There was no adjudication process involving multiple expert readers or diagnosticians as would be seen for image-based AI/ML devices. The "clinical study" was a collection of user feedback.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done.
This is an application for a physical device, not an AI/ML diagnostic or assistive tool. Therefore, there was no comparison of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
N/A.
This applies to AI/ML algorithms. The device is a physical mask used by a human. Its performance is inherent in its physical function and user experience.
7. Type of Ground Truth Used
The "ground truth" for the effectiveness of the device in alleviating snoring and improving sleep quality was established through:
- Self-reported user feedback: From the clinical questionnaire regarding usability, benefits, and overall experience.
- Bed-partner observations: Users reported that their bed partners noticed improvement in snoring.
- Epworth Sleepiness Scale (ESS) scores: Self-administered questionnaire to assess daytime sleepiness before and after using the mask in new users (Group 2) and after use in existing users (Group 1). This is an outcomes-based measure for symptoms.
8. Sample Size for the Training Set
N/A.
This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
N/A.
As there is no AI/ML algorithm, there is no training set or ground truth establishment for a training set.
§ 874.3900 Nasal dilator.
(a)
Identification. A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.