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The Ultra Mirage II Mask is intended for multipatient re-use for adult patients prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinic and home environments.

The Ultra Mirage II Mask is designed for adult patients for the delivery of non-invasive ventilatory support using continuous positive airway pressure or bi-level therapy. It is intended for multiplepatient re-use and is minimally obtrusive to the user, providing a high level of comfort, ease-of-use and seal. The Ultra Mirage II Mask is a nasal mask supported by headgear to allow a seal with the patients face. The Ultra Mirage II Mask may then be connected via tubing to a CPAP or bi-level flow generator. Ventilation is applied to the lungs in a non-invasive manner. The Ultra Mirage II Mask comes in one frame size with four cushion variants (standard, large, shallow, shallow-wide).

The provided text describes a 510(k) premarket notification for the "Ultra Mirage II Mask," a device for delivering non-invasive ventilatory support. The key focus of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than defining and proving specific acceptance criteria in the manner one might find for a novel AI/software device.

Therefore, the information requested, which is typically relevant for studies validating AI models against specific performance metrics (like sensitivity, specificity, or AUC), is largely not applicable or not present in this document.

However, I can extract the relevant information regarding the equivalence study and any performance details.

Here's a breakdown of the available information structured as requested, with "N/A" where the information is not provided or applicable to this type of medical device submission:

Acceptance Criteria and Device Performance for Ultra Mirage II Mask

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The submission refers to "performance testing" but does not detail the number of subjects or tests conducted.
• Data Provenance: Not specified, but generally, such testing for physical medical devices would involve laboratory tests and potentially user trials. Not explicitly prospective or retrospective.

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

• N/A. This type of device (a mask) does not typically involve expert-established ground truth in the way an AI diagnostic algorithm would. The "ground truth" for performance would likely be engineering specifications, physical measurements, and clinical usability assessments.

4. Adjudication Method for the Test Set

• N/A. Not applicable to the performance testing described for this device.

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

• No. This is not an AI/software device, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• For Safety: Compliance with ISO 10993 standards for materials biocompatibility.
• For Effectiveness: Direct comparison of technological characteristics and performance (e.g., seal, comfort, ease of use, ventilatory support delivery) to defined predicate devices, with the goal of demonstrating "substantial equivalence." The specific metrics of this comparison are not detailed in the provided text.

8. The Sample Size for the Training Set

• N/A. This is not an AI/machine learning device that uses a "training set."

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

• N/A. Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document highlights a performance testing study designed to demonstrate the "substantial equivalence" of the Ultra Mirage II Mask to existing predicate devices (Modular Mask K961783 and Mirage Activa K032916).

• Proof of Safety: The biocompatibility of materials used in skin-contacting and air-path components was verified through testing to ISO 10993 standards by an independent certified laboratory.
• Proof of Effectiveness/Equivalence: General "performance testing" was conducted to confirm that the Ultra Mirage II Mask is substantially equivalent in its fundamental scientific technology to the predicate devices. The document states that the results of this testing supported the claim of substantial equivalence. While specific performance metrics or detailed test results are not included in this summary, the FDA's clearance (K050359) indicates they review this data and found it sufficient for the claim of substantial equivalence. The design is explicitly stated as being "with a minimal number of design changes" from the original Ultra Mirage Mask, further emphasizing the equivalence approach. The submission also refers to the Ultra Mirage II Mask's equivalence to existing ResMed mask fittings for Autoset Spirit (K013843) and S7 Elite (K013909), suggesting consistency with established product lines.

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