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The Willow™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow ™ is:
(1) to be used by adult patients (> 66lb / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed.
(2) to be used for single-patient reuse in the home environment.

The 3B Willow™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
The 3B WillowTM is a prescription device supplied non-sterile.

This document describes the 3B Willow™ Nasal Mask and its substantial equivalence to predicate devices, focusing on technological characteristics and performance bench testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ResMed Mirage Swift II), rather than establishing novel acceptance criteria for a new device type. The "acceptance criteria" are implicitly defined by the reported performance of the predicate device.

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

The document explicitly states: "To verify the substantial equivalence claim, the Willow™ was performance bench tested against the ResMed Mirage Swift (K042043)."

• Sample Size for Test Set: The document does not specify a numerical sample size for the bench testing. It refers to general "performance bench testing." For this type of device (nasal mask), this typically involves testing a small number of production units.
• Data Provenance: The data is generated from bench testing performed on the 3B Willow™ Nasal Mask and compared against the specifications of the ResMed Mirage Swift II. There is no indication of human subject data, country of origin, or retrospective/prospective nature as this is a physical device performance comparison.

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

Not applicable. This is a bench test comparing physical performance characteristics of a medical device against a predicate device's specifications. It does not involve expert review or ground truth establishment in the clinical diagnostic sense. The "ground truth" here is the established and publicly available performance specifications of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable. As this is bench testing of physical properties against technical specifications, there is no need for adjudication by experts. The measurements are objective.

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 is a physical medical device (nasal mask) and not an AI/software as a medical device (SaMD) that would involve human readers or AI in diagnostic interpretation.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

The ground truth used for comparison is the published performance specifications and characteristics of the predicate device, ResMed Mirage Swift II (K042403), derived from its 510(k) submission and/or product documentation.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment for a training set.

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