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The HumidAire 2i is indicated for the humidification of the air delivered from a ResMed compatible CPAP therapy device.

The HumidAire 2i is intended for single patient re-use in the home environment and multi-patient re-use in a hospital / institutional environment.

The HumidAire 2i is for use only as recommended by a physician.

ResMed's HumidAire 2i™ is a humidify the air delivered to the airway during continuous positive airway pressure (CPAP), automatic positive airway pressure (APAP) and bilevel therapy.

The HumidAire 21™ is designed to form a single heated humidification unit when attached to a CPAP, APAP or bilevel device.

The HumidAire 21™ is intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

The ResMed HumidAire 2i is a respiratory gas humidifier. The provided documentation does not detail a clinical study with acceptance criteria and a test set for device performance in the way typically associated with AI/ML devices. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through adherence to established standards and engineering design verification.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not applicable for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "Design and Verification activities were performed on the HumidAire 2i™ as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria." However, the specific acceptance criteria and the quantitative results of these tests are not provided in the given text.

The "device performance" is implicitly demonstrated through its substantial equivalence to predicate devices and compliance with relevant FDA guidance documents and standards related to respiratory gas humidifiers and reprocessing of medical devices.

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

This information is not applicable in the context of the provided documentation. The submission focuses on engineering design verification and demonstrating substantial equivalence to predicate devices, rather than a clinical study involving a "test set" of patient data for performance evaluation in the way an AI/ML device would.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable. The ground truth in this context would be related to the device's functional specifications and safety, established through engineering and regulatory standards rather than expert clinical consensus on a test set.

4. Adjudication Method

This information is not applicable. There's no clinical "test set" requiring adjudication.

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

This information is not applicable. The HumidAire 2i is a medical device (humidifier), not an AI-assisted diagnostic or therapeutic tool that would typically involve an MRMC study.

6. Standalone Performance Study

This information is not applicable in the context of an "algorithm only without human-in-the-loop performance." The device itself has standalone functionality as a humidifier when attached to a CPAP device. Its performance is assessed through engineering testing and compliance with standards, not an AI-specific standalone performance study.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Engineering specifications and design requirements: These define how the humidifier should function (e.g., humidification output, temperature control, safety features).
• Compliance with applicable standards and requirements: As listed in the document (e.g., FDA Draft Reviewer Guidance for Ventilators, FDA Heated Humidifier Review Guide, and guidance on reprocessing reusable medical devices).
• Substantial equivalence to predicate devices: The predicate devices (AutoSet Spirit™ with H2i and VPAP ADAPT™ with H2i) have established safety and effectiveness.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable. There is no "training set" as this is not an AI/ML device.

Summary of Device-Specific Information from the Text:

• Intended Use: Humidification of air delivered from a ResMed compatible CPAP therapy device. Intended for single-patient re-use in home environment and multi-patient re-use in hospital/institutional environment.
• Device Description: Forms a single heated humidification unit when attached to a CPAP, APAP, or bilevel device.
• Substantial Equivalence: Demonstrated through similar intended use (with modification for multi-patient re-use), same operating principle, same technologies, and same manufacturing process as predicate devices.
• Compliance: The device complies with applicable standards and FDA guidance documents related to ventilators, premarket notification submissions, reprocessing of single-use devices, labeling reusable medical devices, and heated humidifiers.

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