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The nasal CPAP unit is intended for treatment of adult Obstructive Sleep Apnea (OSA). Obstructive sleep apnea is defined as the absence of air movement for ten seconds during sleep. Obstructive sleep apnea is usually diagnosed by a sleep study. The study obtains the optimum level of pressure required to maintain an unobstructed airway, the positive pressure allows the is ve or prosuropen. The nasal CPAP unit is intended only for spontaneously breathing adult patients.

The SoftAire Nasal CPAP System is intended to provide continuous positive airway pressure for the care and treatment of individuals suffering from obstructive sleep apnea. The positive pressure is clinician adjustable within the designated operating range and a clinician adjustable timer will allow timed rise to pressure ("Ramp" mode). The user controls will be limited to an on/off switch and option of using the timed pressure rise. This product is designed to be used with a 22 millimeter (smooth bore) tube air delivery system and user selected nasal mask. This mask is not marketed by Bird. Power will be provided by AC to DC adapter s which accommodate a variety of input voltages and frequencies. This adapter will plug into a 12 VDC connector on the side of the unit. The SoftAire Nasal CPAP System does not utilize an actively controlled exhalation valve. The patient circuit consists of two essential parts: a large-bore tube from the ventilator to the patient and a required exhaust port. The exhaust is an orifice which may be part of the adapter between the tubing an the patient mask, or may be an orifice which is part of the patient mask.

Acceptance Criteria and Device Performance for SoftAire Nasal CPAP System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

The document does not provide details on specific sample sizes used for the test set or the data provenance. It states, "Performance testing was conducted in the laboratory to confirm operation compliance to the device specifications." This implies that the testing was likely conducted in a controlled lab environment and not necessarily with patient data from a specific country, nor does it specify if it was retrospective or prospective.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

The document does not mention the use of experts or their qualifications for establishing ground truth for the test set. The performance testing appears to be based on engineering and regulatory standards rather than clinical expert evaluation.

4. Adjudication Method (Test Set)

There is no mention of an adjudication method in the provided text. The performance was confirmed against predefined specifications.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document describes a medical device clearance process, not a study comparing human readers with and without AI assistance.

6. Standalone Algorithm Performance

This section is not applicable as the device is a physical medical device (CPAP system), not an algorithm or AI system for diagnostic or interpretive purposes. The performance assessment is for the device's functional specifications.

7. Type of Ground Truth Used

The "ground truth" for the performance testing was based on pre-defined engineering and regulatory specifications and requirements (e.g., pressure accuracy, noise level, safety standards). It did not utilize expert consensus, pathology, or outcomes data in the context of clinical performance, but rather compliance with technical specifications.

8. Sample Size for the Training Set

This question is not applicable. The SoftAire Nasal CPAP System is a hardware device, not a machine learning model, and therefore does not have a "training set" in the context of AI/ML development.

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

This question is not applicable for the same reason as point 8.

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