(113 days)
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."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Seal via dual wall silicone interface | The new device has a dual wall silicone interface, similar to the predicate Mirage FFM Series 2, providing seal. |
| Adequate fit range (various sizes) | Both masks are offered in various sizes to ensure adequate fit range. |
| Continuous air leak via vent holes (CO2 flush, minimize rebreathing) | Both masks incorporate vent holes to provide continuous air leak, flush dead space, and minimize CO2 rebreathing. |
| Built-in Anti-Asphyxia Valve with vent holes (fresh air in case of device failure) | Both masks include built-in Anti-Asphyxia Valve which, with vent holes, allows fresh air in device failure. |
| Connection to conventional air delivery hose via standard conical connectors (ISO 5356-1) | Both masks connect via standard conical connectors, reference ISO 5356-1. |
| Materials deemed safe (ISO 10993) | All components of both masks are fabricated using materials deemed safe, reference ISO 10993. |
| Construction using molded plastic components and fabric headgear | Both masks are constructed using molded plastic components and fabric headgear. |
| Pressure flow characteristics substantially equivalent to predicate | The pressure flow characteristics of the new device are substantially equivalent to the predicate device. |
| Functional dead-space substantially equivalent to predicate | The functional dead-space of the new device is substantially equivalent to the predicate device. |
| Physical dead space substantially equivalent to predicate | The physical dead space of the new device is substantially equivalent to the predicate device. |
| Flow impedance substantially equivalent to predicate | The flow impedance of the new device is substantially equivalent to the predicate device. |
| Compatibility with additional sterilization methods (compared to Mirage Swift) | The new device is compatible with an additional method of sterilization compared to the predicate Mirage Swift. |
| Compliance with ResMed's 21 CFR Part 820 compliant Quality Management System | Both masks are designed and constructed under ResMed's 21 CFR Part 820 compliant Quality Management System. |
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.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).