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510(k) Data Aggregation
(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.
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(112 days)
The Swift™ Air channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The Swift Air is:
- to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed
- intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
The Swift™ Air provides an interface such that air flow from a positive pressure source is directed to the patient's nasal nares. The mask is held in place with adjustable headgear that straps the mask to the face.
Swift™ Air is a prescription device supplied non-sterile.
This document describes the premarket notification for the ResMed Swift™ Air nasal mask. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Predicate Device(s) | Acceptance Criteria | Reported Device Performance (Swift™ Air) |
|---|---|---|---|
| Intended Use | Mirage FX (K102746) | Identical intended use as the predicate device, for use with Positive Air Pressure therapy equipment and the same patient population. | Identical intended uses: Channels airflow noninvasively to a patient from a PAP device (CPAP or bilevel), for patients > 66 lb/30 kg, single-patient re-use in home, multi-patient re-use in hospital/institutional environment. |
| Biocompatibility | Swift™ FX (K090244) | All materials used in the construction must be deemed as safe as those of the predicate devices, in accordance with FDA Guidance #G95-1 and ISO 10993-1. Specific tests for heated humidified gas pathway (ISO 10993-3, -5, -6, -10) and skin contact (ISO 10993-5, -10). | All materials used in the construction of the new mask are deemed as safe as those of the predicate devices. Appropriate biological tests (ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, ISO 10993-10 Sensitization for heated gas pathway; ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation for skin contact) were conducted and passed. |
| CO2 Performance (Venting) | Ultra Mirage II (K050359) | Adequate venting to flush out expired CO2, satisfying predefined pass/fail criteria and being substantially equivalent to the predicate device. | CO2 performance of the new device (both vent types) was tested, including physical and functional dead-space measurements. The device satisfied all predefined pass/fail criteria and was shown to be substantially equivalent to the predicate Ultra Mirage II. |
| Pressure-Flow Characteristics & Flow Impedance | Swift™ FX (K090244) | Identical pressure-flow characteristics and flow impedance to the predicate device, operating on the same ResMed flow generator settings. | Pressure-flow and through impedance bench test results of the new mask were substantially equivalent to the predicate Swift FX. |
| Mechanical Integrity & Performance | (General Safety) | Withstand simulated normal use and reasonable abuse scenarios, and the effects of storage temperature, humidity, and transportation shock & vibration. | Mechanical integrity and performance were tested to simulated normal use and reasonable abuse scenarios. The device was tested to demonstrate it can withstand storage temperature, humidity, and transportation shock & vibration. Device development complies with ISO 14971:2007 (risk management). |
| Cleaning and Reuse | (General Safety) | Device can be safely reused (single-patient home, multi-patient hospital) following validated disinfection protocols, and function as intended after specified cleaning/disinfection cycles. | Validation of cleaning and reuse was completed. After 20 cycles of cleaning/disinfection in accordance with described methods, the device was shown to function as intended. The device satisfied pass/fail criteria and was shown to be substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The review document does not specify a "test set" in the context of clinical data for performance evaluation of the Swift™ Air mask. The evaluation relied heavily on bench testing and comparison to predicate devices to demonstrate substantial equivalence.
- Clinical Data: "Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate substantial equivalence to the predicate devices." This indicates no new clinical studies with a specific patient "test set" were conducted for the Swift™ Air for this submission.
- Bench Testing: The sample sizes for the various bench tests (CO2 performance, pressure-flow, mechanical integrity, cleaning/reuse) are not explicitly stated in the provided text. The data provenance is presumed to be internal laboratory testing conducted by ResMed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, the evaluation was based on bench testing and comparison to predicate devices, not on expert-adjudicated clinical patient data or specific "ground truth" established by experts for a test set.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical "test set" requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study was not performed. This device is a medical accessory, and its effectiveness is determined by its physical and functional characteristics in delivering CPAP/Bilevel therapy, rather than diagnostic interpretation requiring human readers.
6. Standalone Performance Study (Algorithm only without Human-in-the-Loop Performance)
Yes, implicitly. The performance data presented (CO2, pressure-flow, mechanical integrity, cleaning/reuse) represents the "standalone" performance of the device itself, under bench test conditions. This is the equivalent of "algorithm only" in the context of a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the Swift™ Air device in this submission was established by:
- Predicate Device Performance: The primary "ground truth" was the established performance and safety profiles of the predicate devices (Mirage FX, Swift™ FX, Ultra Mirage II) that have already been cleared by the FDA.
- Industry and Regulatory Standards: Adherence to standards such as FDA Guidance #G95-1, ISO 10993-1 (Biocompatibility), ISO 14971:2007 (Risk Management), and ISO 5356-1:2004 (Conical Connectors) served as additional "ground truth" for safety and performance requirements.
- Predefined Pass/Fail Criteria: For the bench tests (e.g., CO2 performance, mechanical integrity), "predefined pass/fail criteria" were used as the immediate ground truth, though these criteria would have been derived from relevant standards and predicate performance.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" in the context of this device. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
Not applicable. As there was no training set, there was no ground truth for a training set to be established.
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