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The Dream Wear Silicone Pillows Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

The DreamWear Silicone Pillows Mask consists of a nasal pillows cushion, a silicone mask frame, an elbow with swivel and exhalation ports, headgear with arm extenders, and optional fabric sleeves. The nasal pillows cushion tips seal at the entrance to the nillows cushion base sits under the nares, and comes in four sizes (small, medium, medium wide, large).

Exhalation ports are incorporated into the mask. The built-in exhalation ports are molded into the front of the cushion as well as the top of the elbow. The mask exhalation ports for the DreamWear Silicone Pillows Mask were incorporated in both components, rather than only one of these components, to optimize diffusion, noise, comfort of breathing and CO2 inside the mask. The exhalation openings are used to flush exhaled CO2 out of the circuit. The fabric headgear is attached through the slots on the left and right headgear arms, which in turn are inserted into the slots on the sides of the frame to support the mask fit. The headgear can be adjusted with the hook and loop tabs. The elbow is inserted to the top of the frame. The fabric headgear goes over the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. Fabric sleeves (optional) are also provided to provide additional comfort if desired.

The mask design is intended to remove movement restrictions during sleep with the air inlet on the top of the head and air movement through both sides of the frame and cushion for therapy delivery to the patient's nose. The tubing frame is intentionally designed such that one side can collapse when the patient is lying on their side, while therapy is delivered to the cushion through the open side of the frame. The frame is available in three sizes (small, medium, and large) The mask was tested and verified to ensure performance is maintained according to its specifications.

The mask elbow can rotate freely through 360 degrees and has a 22mm quick disconnect swivel that is used to connect the conventional air delivery hose between the mask and pressure source. The 22mm quick disconnect swivel can also rotate freely through 360 degrees and be easily removed from the elbow.

The mask is designed in such a way that they can be easily disassembled for cleaning or replacement purposes. The mask components may be cleaned by the patient in the home (single patient use) or disinfected by the professional in the hospital/institutional environment (multi-patient use).

The key benefits of this device to the patient are:

• Ease of use ●
• . Comfort
• Fewer movement restrictions ●
• Easy disassemblv .

The provided text describes the regulatory clearance for a medical device, the DreamWear Silicone Pillows Mask, and compares it to a predicate device, the TI Nasal Mask. However, it does not describe an AI model or a study proving that an AI-driven device meets acceptance criteria.

The document details the device's design, intended use, and various performance characteristics through non-clinical laboratory testing, not a clinical study involving human readers or AI.

Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device based on this input. The document explicitly states:

• Clinical Tests: "Clinical tests were not required to demonstrate the safety and effectiveness of the DreamWear Silicone Pillows Mask. All risks have been sufficiently mitigated and product functionality has been adequately assessed by non-clinical tests." (page 13)

This product is a physical medical device (a CPAP mask), not an AI-powered diagnostic tool. The performance metrics discussed (e.g., pressure drop, sound levels, CO2 rebreathing, leaks) are physical or mechanical properties of the mask itself, verified through laboratory tests (non-clinical tests), not cognitive performance metrics of an AI.

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