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The Seattle-PAP is intended to provide continuous positive airway pressure (CPAP) to spontaneously breathing neonates and infants, up to weights of 10 kg, requiring respiratory support due to conditions associated with prematurity, such as Respiratory Distress Syndrome, or other conditions where CPAP is required or desired and prescribed by a physician. It is for use only by trained medical personnel in hospital clinical environment, such as the Neonatal Intensive Care Unit (NICU) and Pediatric Intensive Care Unit (PICU).

Seattle-PAP is a bubble continuous positive airway pressure (CPAP) device. Seattle-PAP is installed at the end of an expiratory limb, distal to the patient, in a continuous gas flow breathing system. Seattle-PAP is intended to assist spontaneous breathing in neonates and infants, up to weights of 10 kg. Seattle-PAP is comprised of two key elements; a water container and a tube inserted into the water. The Water Reservoir contains the water and has a Lid permanently attached to help prevent splashing and spillages. The Lid has an integrated Water Level Adjustment Port, so a clinician can adjust the water level in the Reservoir, if necessary, without disconnecting the breathing circuit. The tube is comprised of a Funnel-Swivel that is permanently attached to Bubble Tube. The Funnel-Swivel helps prevent spillages when filling the Water Reservoir initially and can rotate to help reduce tension that may build up in the expiratory limb of the breathing circuit. The expiratory end of the patient's breathing circuit, distal to the patient, is inserted into the center of the Funnel-Swivel. A Bubble Tube Lock mechanism is used to ensure the depth of the tube in the water does not change unintentionally. The gas bubbling out of the end of the Tube creates air pressure oscillations in the breathing circuit. These pressure oscillations do not adversely affect the performance of the Seattle-PAP device, i.e. the ability to deliver the desired CPAP pressure accurately.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Seattle-PAP device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical performance testing. The testing summary lists various tests performed but does not delve into the specifics of how many devices were tested or under what conditions beyond the environmental parameters.

3. Number of Experts Used and Qualifications:

The document does not mention using experts to establish ground truth for a test set, expert qualifications, or any process involving expert review for determining device performance. The testing described is non-clinical performance testing of the device itself.

4. Adjudication Method:

Since there's no mention of expert involvement or ground truth establishment based on human review, there is no adjudication method described.

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

The document does not describe an MRMC comparative effectiveness study. The "Comparison of MAP control Seattle-PAP vs. Predicate Fisher & Paykel (K100011)" is a non-clinical, device-to-device comparison based on physical measurements, not human reader performance.

6. Standalone (Algorithm Only) Performance:

The Seattle-PAP is a physical bubble CPAP device, not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The testing described is for the physical device's performance characteristics.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical performance testing of the Seattle-PAP device is based on instrumental measurements and engineering specifications. For example, pressure accuracy is measured against a known standard, and flow rates are controlled and measured. It's not based on expert consensus, pathology, or outcomes data, as this is a physical medical device.

8. Sample Size for the Training Set:

The Seattle-PAP is a physical medical device and does not have a "training set" in the context of an AI/ML algorithm. Therefore, this information is not applicable and not provided in the document.

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

As the device is not an AI/ML algorithm, the concept of a "training set" and establishing "ground truth for the training set" is not applicable. The device's design and operation are based on established physiological principles and engineering.

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