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The Nasal Comfort Freedom provides a conduit such that airflow from a positive pressure source is directed to a patient's nose. The device is intended for adult patients (>66 lb/30kg) for whom positive airway pressure has been prescribed. The device is single-patient re-use, and is intended for use in a clinical or home-use environment.

The Nasal Comfort Freedom is a medical device that is capable of connection to a positive pressure source, and provides a conduit for delivery of an air flow to a patient's nose. The device is a single-patient re-use device supplied non-sterile by prescription. The Nasal Comfort Freedom interfaces with the patient by way of nasal pillows assembled into a breathing chamber. The nasal pillows and breathing chamber are soft and flexible to conform to the patient's nose. A rotating elbow is connected to the breathing chamber and incorporates a passive vent for exhaled gases to escape the device. The elbow is permanently connected at its distal end to a rotating connector. The Rotating Connector provides a means by which air supply may be connected and disconnected from the breathing mask via two clips incorporated into the Tubing Connector. The supplied tubing uses a standard conical fitting for connection to currently marketed 22mm fittings for use with CPAP ventilators and accessories. The Nasal Comfort Freedom is secured to the patient during use by way of a disposable adhesive strip that is fitted over the bridge of the patient's nose. The adhesive on the underside of the Nose Strip provides attachment to the patient's skin, while the outward facing layer of the strip features the loop side of a hook-and-loop fabric. The Breathing Chamber of the mask incorporates two hook fabric strips to be mated with the loop fabric of the Nose Strip. The patient may fit the nasal pillows into the nostrils, and then secure the hook strips over the loop strip on the nose to provide a snug fit of the device. Following each use, the Nose Strip may be removed and discarded by the patient.

The Lakeview Sleep Center, Nasal Comfort Freedom device underwent several non-clinical tests to establish substantial equivalence to predicate devices. These tests assessed device characteristics related to airflow, pressure, gas exhaustion, patient attachment, and material biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nasal Comfort Freedom are implicitly set by matching or demonstrating comparable performance to the predicate devices, ResMed Swift FX (K090244) and Respironics GoLife Nasal Mask (K102502). The table below summarizes key performance attributes and how the Nasal Comfort Freedom's performance compares to these predicates.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical tests summarized under "Summary of Testing" in the 510(k) submission. These tests include:

1. Conical Fitting Testing, ISO 5356-1:2004 (Drop Test, Engagement, Disengagement, Leakage)
2. Resistance to Flow
3. Exhaust Flow
4. Inspiratory and Expiratory Resistance
5. Dead Space Volume
6. CO2 Rebreathing
7. Patient Disengagement
8. Biocompatibility Testing, ISO 10993-1:2009

The "results of performance testing of the Nasal Comfort Freedom demonstrate that it is substantially equivalent to the performance, safety, and effectiveness of the predicate device."

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample size for individual tests (e.g., number of masks tested for resistance to flow). However, the testing appears to be conducted on the device itself and its components in a laboratory setting, rather than through human or animal trials. Therefore, "test set" in this context refers to the manufactured units of the Nasal Comfort Freedom device or its components subjected to the physical and chemical performance evaluations.

• Data Provenance: The data is generated from non-clinical bench testing rather than from clinical studies involving human subjects. The country of origin of the data is not specified beyond the Lakeview Sleep Center being based in Chicago, IL, USA, implying the testing likely occurred in the USA or through US-based contract labs. The nature of the testing is prospective in the sense that the device was manufactured and then subjected to these specific tests to gather performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Not Applicable. For non-clinical bench testing of a device's physical and performance characteristics, ground truth is established by objective measurements against established engineering standards (e.g., ISO, ASTM) or performance characteristics of legally marketed predicate devices, not by expert consensus or interpretation of images/clinical data. The "ground truth" is typically the measured value compared to a defined limit or a predicate's performance.

4. Adjudication Method for the Test Set:

• Not Applicable. Since the "test set" involves physical device measurements against objective standards and predicate device performance, there is no need for an adjudication method in the context of expert review for ambiguous cases. The outcomes are quantitative measurements.

5. 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:

• Not Applicable. This device is a medical device (nasal mask for CPAP) and not an AI/imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The ground truth used for validating the device's performance is based on established engineering standards (e.g., ISO 5356-1:2004, ISO 10993-1:2009) and performance characteristics of legally marketed predicate devices. For example, for "Resistance to Flow," the ground truth is the measured value compared to known values for predicates. For "Conical Fittings," the ground truth is compliance with ISO 5356-1:2004.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device. There is no concept of a "training set" in the context of machine learning for this type of device. The device itself is manufactured to specifications.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no training set for this physical medical device, there is no ground truth to be established for it.

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