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AirLife Adult Heated Wire BiPAP/NIV Circuit is intended for use with adult population that requires mechanical ventilation. The AirLife Adult Heated Wire BiPAP/NIV Circuit is used with spontaneously breathing individuals that benefit from high flow therapy.

The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinicians. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to work with noninvasive ventilators and compatible to the Fisher & Paykel MR850 humidifier.

The AirLife Adult Heated Wire BiPAP/NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated wire circuit is intended for use for adult population that requires non-invasive (NIV) mechanical ventilation. It is intended for spontaneously breathing individuals who require mechanical ventilation. The duration of use is up to 7 days in a hospital environment. The aim is to maintain adequate ventilation and minimize the effort of breathing.

The AirLife Adult Heated Wire BiPAP/NIV Circuit is a corrugated plastic tube with a spiral resistance wires within the tubing that generate heat to maintain temperatures and humidity. It is intended to warm gases before they enter a patient's airway. The device delivers humidity to patients requiring active non-invasive humidification, acting as a conduit transporting gases between ventilators, humidifiers and the patient. The AirLife Adult Heated Wire BiPAP/NIV Circuit is designed to operate at a minimum flow rate of 3 LPM and a maximum flow rate of 60 LPM.

The AirLife Adult Heated Wire BiPAP/NIV Circuit is a medical device designed to warm and deliver breathing gases to adult patients requiring non-invasive mechanical ventilation. The device was tested against several industry standards to ensure its safety and effectiveness.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were defined by compliance with various international standards related to breathing system heaters, anesthetic and respiratory equipment, and biocompatibility. The reported device performance uniformly indicated "Pass" for all tested characteristics, demonstrating that the device meets these established standards.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size for individual tests conducted to prove compliance. However, the tests are a series of non-clinical performance and biocompatibility assessments performed on the device itself (e.g., inspiratory limb, extension line, dry line, system leak, resistance to flow). These typically involve a sufficient number of units to ensure statistical confidence and representativeness of the manufacturing process, as per the requirements of the standards cited.

The data provenance is from laboratory testing (non-clinical) of the device. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these are not relevant for non-clinical device performance studies.

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

For non-clinical performance and biocompatibility testing as described, the "ground truth" is established by the specified parameters and methodologies outlined in the referenced international standards (e.g., ISO, AAMI/ANSI/IEC standards). The experts would be the engineers, scientists, and technicians who are trained and qualified to conduct these tests according to the standard operating procedures derived from these international standards. Their qualifications would typically include degrees in relevant engineering or scientific fields, experience in medical device testing, and specific training on the standards being applied. The document does not specify the number of individual experts, as it is a standard part of a manufacturer's quality system to have qualified personnel perform such testing.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data by multiple human readers (e.g., radiologists reading images). This is a non-clinical performance and biocompatibility study. The "adjudication method" in this context is the comparison of the test results against the acceptance criteria defined by the relevant standards. A simple "Pass" or "Fail" determination is made based on whether the device's performance meets or exceeds the specified thresholds in the standards.

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

No. An MRMC comparative effectiveness study was not conducted, nor is it applicable to this type of device. MRMC studies are used to evaluate human reader performance, often with and without AI assistance, usually in diagnostic imaging. This device is a heated breathing circuit, and its performance is assessed through objective physical and biological tests, not by human interpretation or AI assistance in a clinical setting related to diagnosis.

6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)

Yes, in a sense. The document describes the standalone (algorithm equivalent) performance of the device. The entire set of tests detailed under "Performance Testing" and "Biocompatibility" (e.g., System Leak Test, Resistance to Flow, Humidity Output, Cytotoxicity) measures the intrinsic performance characteristics of the device itself without direct human intervention in its operation during the test, beyond setting up and initiating the test. There is no "algorithm" in the conventional sense of AI, but rather the physical and chemical properties and functionality of the device are evaluated.

7. Type of Ground Truth Used

The ground truth used is based on established objective technical standards and regulatory requirements. This includes:

• Engineering/Performance Specifications: Derived from standards like ISO 5367, ISO 8185, ISO 5356-1, IEC 60601-1, and IEC 60601-1-2. These standards define acceptable ranges and limits for physical performance characteristics.
• Biocompatibility Standards: Derived from ISO 10993 series, which define acceptable levels of biological response for medical devices in contact with the body.

8. Sample Size for the Training Set

This is a non-clinical study for a medical device's physical and biological properties, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The device itself is the product being tested, not an algorithm being developed. The manufacturing process of the heated breathing circuits would have undergone internal validation and development which may involve iterative testing, but this is distinct from an AI training set.

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

As there is no "training set" in the AI sense, this question is not applicable. For the manufacturing process, the "ground truth" (i.e., desired specifications and performance) would be established through a combination of design requirements, risk analysis, and engineering specifications based on relevant standards and intended use.

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