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510(k) Data Aggregation
(88 days)
Phoenix, Arizona 85020
Re: K181219
Trade/Device Name: OptiPillows EPAP Mask Regulation Number: 21 CFR 874.3900
Pillows Mask Classification name: Nasal Dilator Review Panel: Ear Nose and Throat Regulation Number: 874.3900
|
| Product Code | LWF | LWF |
| Regulation # | 874.3900
| 874.3900 |
| Safe | Yes | Yes
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.
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(99 days)
Common Name: | Nasal Dilator |
| Classification Name: | 21 CFR 874.3900
Hillsborough, CA 94010
Re: K120665
Trade/Device Name: InVent Snoring Device Regulation Number: 21 CFR 874.3900
The InVent Snoring Device is intended to reduce or eliminate snoring.
As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.
The provided text does not contain detailed acceptance criteria or a comprehensive study description with all the requested information categories. However, based on the available text, here's an attempt to answer your questions as much as possible:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states that "Bench testing of the subject device confirms that it meets pre-defined specifications" and "Clinical testing also supports that the device is safe and effective for its intended use." However, it does not provide specific quantitative acceptance criteria or detailed performance metrics. The primary claim for regulatory approval is substantial equivalence to a predicate device, not necessarily meeting a specific set of performance thresholds outlined in a table.
Therefore, a table of acceptance criteria and reported device performance cannot be generated with the given information as the specific criteria and corresponding performance values are not disclosed. The device is intended to "reduce or eliminate snoring."
Study Information (Based on available text)
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The text states "Clinical testing also supports that the device is safe and effective for its intended use." However, it does not provide any details about the sample size, the country of origin of the data, or whether the study was retrospective or prospective. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the text. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the text. -
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 is not an AI device. The InVent Snoring Device is a physical nasal dilator. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not an AI device. Therefore, a standalone algorithm performance study is not applicable and was not performed. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the device's function (reducing snoring), the "ground truth" for effectiveness in a clinical study would likely involve objective measurements of snoring (e.g., sound intensity, apnea-hypopnea index if linked to sleep-disordered breathing) or subjective patient/partner reports of snoring reduction. However, the text does not specify the type of ground truth used in their clinical testing. -
The sample size for the training set:
This is not an AI/algorithm-based device, so the concept of a "training set" in the context of machine learning is not applicable here. -
How the ground truth for the training set was established:
As above, the concept of a "training set" and its ground truth is not applicable for this physical device.
Summary of what can be gleaned from the text:
- Device Type: Nasal dilator for snoring.
- Approval Basis: Substantial equivalence to a predicate device (BR2 Nasal Dilator).
- Performance Evidence:
- Bench testing confirmed conformity to "pre-defined specifications" (details not provided).
- Clinical testing supported "safety and effectiveness for its intended use" (details not provided).
- Missing Information: Specific acceptance criteria, detailed performance metrics, sample sizes for any studies, data provenance, expert qualifications, ground truth establishment methods, and any AI/algorithm-related study details are absent because the device is not an AI product.
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(197 days)
Terrace Dacula, GA 30019
Re: K040491
Trade/Device Name: Chin-Up Strip® Regulation Number: 21 CFR 874.3900
The Chin-Up Strip promotes and enhances nasal breathing to help Breathe Right nasal strips to reduce or eliminate snoring.
The Chin-Up Strip supports the chin (mandible) during sleep, thereby promoting and reducing mouth breathing and oral venting.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a device called "Chin-Up Strip", indicating that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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