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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.

AI/ML Overview

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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K Number

K172335

Device Name

Bleep DreamPort

Manufacturer

snapCPAP

Date Cleared

2018-03-30

(240 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K112404,K102502

Predicate For

N/A

Intended Use

The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg, for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.

Device Description

The Bleep™ DreamPort nasal adhesive mask is similar to standard nasal pillow CPAP mask for use with patients using CPAP and bi-level equipment for the treat of OSA. The Bleep™ DreamPort nasal adhesive mask is comprised of 2 sub-assemblies: Nasal Port assembly and Airflow management assembly. The device uses single use foam tape to create the seal at the nostrils. This allows the interface to be used without head gear. There is a reusable interface which connects the nasal adhesive to the circuit of the CPAP equipment. It includes integrated exhalation ports.

AI/ML Overview

The provided text describes the Bleep™ DreamPort nasal adhesive mask and its acceptance criteria for FDA clearance, comparing it to a predicate device (Resmed Swift LT). The study primarily focuses on non-clinical performance testing and a limited user study to demonstrate substantial equivalence, rather than a typical multi-reader multi-case (MRMC) or standalone AI performance study. Therefore, some of the requested information, particularly regarding AI-specific criteria, human reader improvement, and extensive expert ground truth establishment, is not applicable to this device's clearance process as described.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device (Resmed Swift LT, K073638) and compliance with international standards like ISO 17510-2:2015 and ISO 10993-1.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (Bleep™ DreamPort)	Assessment
Indications for Use	Intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system for adult patients (≥66 lbs. / 30 kg) for whom positive airway pressure has been prescribed. For single-patient reuse in home, hospital/institutional environment.	The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg.) for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.	Met: Identical Indications for Use to predicate.
Patient Population	Adults > 66 lbs. / > 30 kg.	Adults > 66 lbs. / > 30 kg.	Met: Identical Patient Population to predicate.
Environment of Use	Single-patient reuse in the home, hospital/institutional environment.	Single-patient reuse in the home, hospital/institutional environment.	Met: Identical Environment of Use to predicate.
Therapy Pressures & Compatibility	Used with equipment providing therapy pressures within a defined range.	4 to 15 cm H2O. Used with equipment which provide pressures within the defined therapy pressure range.	Met: Compatible within a defined range. While the predicate is 4-20 cm H2O, the Bleep still operates within a common CPAP range.
CO2 Washout Profile (ISO 17510-2)	< 20% increase from baseline (compared to the predicate, though the predicate's data wasn't explicitly tested here).	Pressure ETCO2% at mask: 4 cm H2O 5.3 (2%), 5 cm H2O 5.3 (1%), 10 cm H2O 5.15 (-2%).	Met: Values within acceptable range (minimal increase/decrease).
Exhaust Flow (ISO 17510-2)	Performance comparable to predicate at various pressure settings.	4 - 20.4 Lpm, 8 – 29.2 Lpm, 12 - 35.7 Lpm, 16 - 41.3 Lpm, 20 - 46.0 Lpm.	Met: Values are comparable to (and slightly higher than, implying efficient exhaust) the predicate.
Pressure Drop (ISO 17510-2)	Performance comparable to predicate at various flow rates.	50 Lpm - 0.9 cmH2O, 100 Lpm – 4.4 cmH2O.	Met: Values are lower than the predicate, indicating better flow efficiency.
Dead Space	Comparable to predicate.	16 mL (Predicate: 22 mL).	Met: Smaller dead space than the predicate, which is a positive attribute.
Drop Test	No visual damage.	No visual damage.	Met.
Cleaning of Reusable Components	Performance differences between pre- and post-conditioning < 10% after 90 cycles.	Differences in performance testing between pre- and post-conditioning was < 10%.	Met: Sustained performance after cleaning cycles.
Effects of Aging	Performance differences between pre- and post-conditioning < 10%.	Differences in performance testing between pre- and post-conditioning was < 10%.	Met: Sustained performance after aging simulation.
Shelf-life	Not explicitly stated as a comparative criterion for predicate, but tested for the device.	6 months.	Met: Shelf-life defined.
Biocompatibility (ISO 10993-1, -5, -10)	Non-cytotoxic, non-sensitizing, non-irritating, with Margin of Safety (MOS) > 1 for leachable/extractable components for permanent contact with intact skin.	Non-cytotoxic, non-irritating, non-sensitizing. MOS > 1 for leachable/extractable. Risk-based assessment.	Met: Passed all required biocompatibility tests.
User Study (Clinical Testing)	Demonstrate effectiveness of seal under different CPAP pressure settings and compare leak rates and mean AHI (Apnea-Hypopnea Index).	Found to be substantially equivalent in performance (seal effectiveness, leak rates, mean AHI) over 2 nights.	Met: "Substantially equivalent in performance" is the stated finding.

Study Information:

Sample size used for the test set and the data provenance:
- User study (Clinical Testing): The document states a "user study was performed," but does not explicitly mention the sample size (number of participants/patients).
- Non-clinical performance testing (Bench Tests): This refers to the physical device being tested against standards (e.g., CO2 washout, exhaust flow). No "test set" in the sense of patient data is applicable here; tests are performed on the device itself.
- Data Provenance: Not explicitly stated for the user study (e.g., country of origin, specific clinics). The user study was conducted over "2 nights" for each participant. It's implicitly prospective as it's a "user study" where performance was compared.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- User Study (Clinical Testing): The document does not specify the number or qualifications of experts involved in establishing ground truth (e.g., reading sleep study data). It mentions "mean AHI during use" was compared, implying that existing clinical methods for AHI calculation would be the "ground truth." This is not an AI-specific ground truth establishment (like image annotation by multiple radiologists).
- Non-clinical performance testing: Ground truth here are the engineering standards and measurements, not expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- User Study (Clinical Testing): The document does not specify any adjudication method for the clinical/user study results (e.g., for AHI measurements or leak rates). The comparison was seemingly direct or averaged.
- Non-clinical performance testing: Not applicable.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a medical accessory (mask) and not an AI-powered diagnostic tool, so such a study is not relevant to its clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This is a physical medical device, not an algorithm. Bench testing is the "standalone" performance for the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- User Study: The "ground truth" for the user study appears to be clinical measurements such as leak rates and AHI, which are standard metrics in sleep apnea therapy. This would typically be derived from objective CPAP machine data and sleep study results, often interpreted by sleep physicians. It is not described as involving extensive expert consensus or pathology data.
- Non-clinical performance testing: The ground truth is engineering measurements against established ISO standards.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense. It's a manufactured product whose performance is demonstrated through physical and limited user testing.
How the ground truth for the training set was established:
- Not applicable. See point 7.

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