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The Mirage Quattro channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Quattro is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed.

The Mirage Quattro is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.

The Mirage Quattro provides an interface such that airflow from a positive pressure source is directed to the patient's nose and mouth. The mask is held in place with adjustable headgear that straps the mask to the face.

The Mirage Quattro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The Mirage Quattro is a prescription device supplied non-sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ResMed Mirage Quattro device:

ResMed Mirage Quattro - Acceptance Criteria and Study Analysis

This 510(k) summary focuses on a "Special 510(k): Device Modification" for the ResMed Mirage Quattro, comparing it to a previously cleared version (K063122). The primary modification appears to be an extended therapy pressure range.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for parameters like CO2 performance or pressure-flow characteristics. Instead, it relies on substantiating equivalence to the predicate device.

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

The document states that "Bench testing is sufficient to demonstrate safety and efficacy of the modified Mirage Quattro." This indicates that no clinical "test set" with human subjects was used for this modification. The testing was entirely bench-based, meaning it likely involved laboratory equipment and simulations rather than patient data.

• Sample Size for Test Set: Not applicable, as testing was bench-based.
• Data Provenance: Not applicable, as no human data was collected.

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

Not applicable, as no clinical test set requiring expert ground truth establishment was conducted. The assessment was based on engineering and performance specifications, likely evaluated by internal ResMed engineers and regulatory affairs personnel.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was conducted.

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

No. The document explicitly states, "Bench testing is sufficient to demonstrate safety and efficacy of the modified Mirage Quattro." This rules out any clinical studies, including MRMC studies, for this particular modification.

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

This question is not directly applicable in the context of a medical device like a mask, which is a physical interface and not an algorithm or AI. The testing performed would be considered "standalone" in the sense that it was bench testing of the device itself, without human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this modification was primarily:

• The performance specifications and characteristics of the predicate device (Mirage Quattro K063122), which had previously demonstrated safety and efficacy.
• Engineering and performance test results (e.g., pressure-flow, CO2 flush, material safety) showing that the modified device met these specifications and performed equivalently or acceptably within the extended pressure range.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm or AI model was involved in this device modification.

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

Not applicable, as no machine learning algorithm or AI model was involved.

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The Mirage Quattro channels airflow non invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Quattro is to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.

The Mirage Quattro FFM is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.

The Mirage Quattro FFM provides seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face.

Mirage Quattro FFM is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

Both the masks include built-in Anti-Asphyxia Valve which in conjunction with the vent holes allow the patient to continue to breathe fresh air in the event of positive airpressure device failure or deterioration in the therapy being administered. The design of the mask components is such that the incorporation of these vent holes do not interfere with the intended performance of the masks.

Both the masks connect to conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1).

All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993).

Both the masks are constructed using molded plastic components and fabric headgear.

The main differences are in the number of components, and their design, geometry and how individual components interface with each other. Both the masks are designed and constructed under ResMed's 21 CFR Part 820 compliant Quality Management System.

This device is a medical mask and not an AI/ML device, therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's an analysis of the provided text for the Mirage Quattro™ Full Face Mask:

Acceptance Criteria and Device Performance Study for Mirage Quattro™ Full Face Mask

The provided 510(k) summary for the ResMed Mirage Quattro™ Full Face Mask primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and bench testing, rather than establishing specific quantitative acceptance criteria or conducting extensive clinical trials like those expected for novel, high-risk devices or AI/ML systems.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a non-AI medical device (a mask), the "acceptance criteria" are generally framed around demonstrating comparable performance to predicate devices in key functional areas. The document doesn't explicitly list numerical "acceptance criteria" in the way an AI/ML device would for metrics like sensitivity, specificity, or AUC. Instead, the acceptance is based on demonstrating "substantial equivalence."

The study proving the device meets these criteria is a bench testing study comparing the Mirage Quattro FFM to its predicate devices concerning the performance and safety characteristics listed.

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

• Sample Size for Test Set: The document does not specify a "sample size" in terms of subject count. The testing conducted was bench testing. This typically involves testing a specific number of manufactured masks (e.g., a batch or a statistically relevant number for manufacturing quality) or components. The text states:
  • "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Quattro FFM, as was the case with the predicate device."
  • "The Pressure flow characteristics, functional dead-space, physical dead space and flow impedance of both the new device and the predicate device are substantially equivalent."
• Data Provenance: The data appears to be prospective bench testing conducted by ResMed Ltd. The location of the testing is not explicitly stated, but ResMed's address is in Australia, suggesting the testing was likely overseen or performed there or within their manufacturing facilities.
  • The "country of origin of the data" is implicitly Australia, given the company's location.
  • The study is prospective in the sense that the new device was subjected to testing for the purpose of this submission.

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

• Not applicable (N/A). For a medical mask undergoing bench testing for substantial equivalence, "ground truth" established by human experts in the context of diagnostic interpretation (like in AI/ML studies) is not relevant. The "truth" for characteristics like pressure flow or dead space is established through calibrated measurement equipment and engineering standards.

4. Adjudication Method for the Test Set

• Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in interpreting medical data. This type of adjudication is not relevant for bench testing a respiratory mask.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable (N/A). This is a non-AI medical device (a mask) and does not involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable (N/A). This is a non-AI medical device (a mask) and does not involve any algorithm performance.

7. The Type of Ground Truth Used

• For the bench testing, the "ground truth" for performance characteristics (e.g., pressure flow, dead space, seal integrity, material safety) is established by engineering measurements against predefined specifications and industry standards.
  • ISO 5356-1 (standard for conical connectors) and ISO 10993 (standard for biological evaluation of medical devices) are explicitly referenced, indicating that compliance with these standards (which dictate safety and performance thresholds) forms the basis of the "truth."
  • The comparison is against the predicate device's known performance, which itself would have been established through similar bench testing and compliance with standards.

8. The Sample Size for the Training Set

• Not applicable (N/A). This is a non-AI medical device and does not involve a "training set." The design and engineering process might involve prototypes and iterations, but not a dataset for training an algorithm.

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

• Not applicable (N/A). As there is no training set for an AI/ML algorithm, this question is not relevant.

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