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The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel MR850 humidifier. The AirLife Infant Heated Wire Circuit is used with pediatic population. specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 vears of age) pediatric subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a doctor's supervision and by skilled clinicians. The AirLife Infant Heated Wire Circuit is used for flow rates greater than 4 LPM.

The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifiers.

This document describes the regulatory submission for the AirLife Infant Heated Wire Circuit, a medical device. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML study. Therefore, some of the requested information regarding AI-specific criteria (like MRMC studies, training set details, expert qualifications for ground truth in AI, etc.) is not applicable to this document.

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Device: AirLife Infant Heated Wire Circuit
Intended Use: To deliver and warm breathing gases before they enter the patient's airway, used with a Fisher and Paykel MR850 humidifier for neonatal and infant pediatric populations.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a single table directly comparing acceptance criteria and a single "reported device performance" value for each. Instead, it lists numerous performance tests against established standards. The general acceptance criterion for all these tests is compliance with the specified standard.

Here's a table summarizing the performance characteristics and their corresponding standards, implying that the device met these standards to be considered substantially equivalent. The "Reported Device Performance" column indicates the successful completion of the test in compliance with the standard mentioned.

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

The document does not specify exact sample sizes (e.g., number of circuits tested) for each performance test. It only states that "The following tests were performed for the proposed device to support the substantial equivalence decision." The data provenance is internal testing conducted by the manufacturer to demonstrate compliance with international standards. This is prospective testing against product specifications. There is no mention of country of origin for any data or retrospective analysis as would be relevant for an AI/ML study.

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

This information is not applicable. The "ground truth" for this device is established by objective performance criteria defined in international standards (e.g., ISO, IEC). Performance is measured against these engineering and safety specifications, not against expert human interpretations or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging reads). For device performance testing against objective standards, the results are typically determined by measurement and adherence to predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic accuracy or clinical utility where human readers are involved, often in the context of AI/ML software. This document describes the safety and performance testing of a physical medical device (heated breathing circuit).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a physical heated breathing circuit and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is objective, measurable criteria and limits set forth in recognized international standards (e.g., ISO 5367, ISO 8185, IEC 60601-1, ISO 10993 series). This is akin to engineering specifications and regulatory standards. It is not based on expert consensus, pathology, or outcomes data in the manner relevant to an AI/ML diagnostic system.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The device likely underwent design verification and validation testing, which is similar in concept to testing for traditional devices.

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

This information is not applicable as this is not an AI/ML device and therefore has no "training set" or corresponding ground truth establishment in that context. The "ground truth" for its design and manufacturing is based on established engineering principles, material science, and compliance with the aforementioned international performance and safety standards.

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