(123 days)
The Mirage Liberty 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 Liberty is to be used by adult patients (>66lb />30kg) for whom positive airway pressure has been prescribed. The Mirage Liberty FFM intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital/institutional environment.
The Mirage Liberty 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 Liberty FFM is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. The new device and the predicate mask, provide seal via dual wall silicone interface. Both masks are offered in various sizes to ensure adequate fit range. Both the masks incorporate vent holes in the frame to provide continuous air leak to flush out the dead space within the mask and minimize the amount of CO2 rebreathed by the patient. 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. 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, except the headgear of the new device also includes a molded plastic part.
This document concerns the ResMed Mirage Liberty™ Full Face Mask, a medical device. The submission primarily relies on demonstrating substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria as defined for an AI/CADe device.
Therefore, the requested information elements related to AI/CADe clinical study design (sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types like pathology or outcomes data) are not applicable to this 510(k) summary, as it is for a physical medical device.
The study described is a comparison to predicate devices, and the 'acceptance criteria' are essentially the demonstration of substantial equivalence through bench testing.
Here's the information that can be extracted or deduced from the provided text:
1. Table of "Acceptance Criteria" and Reported Device Performance
Since this is a substantial equivalence submission for a physical device, the "acceptance criteria" are not framed as quantitative metrics for accuracy, sensitivity, or specificity as they would be for an AI/CADe device. Instead, the acceptance is based on demonstrating that the new device is functionally equivalent to existing legally marketed predicate devices.
| Acceptance Criterion (Demonstrating Substantial Equivalence via Bench Testing) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Provide seal via dual wall silicone interface | Both the new device and predicate mask provide seal via dual wall silicone interface. |
| Offer various sizes to ensure adequate fit range | Both masks are offered in various sizes to ensure adequate fit range. |
| Incorporate vent holes for continuous air leak (CO2 washout) | Both masks incorporate vent holes in the frame to provide continuous air leak to flush out dead space and minimize rebreathing CO2. |
| Include built-in Anti-Asphyxia Valve | Both masks include built-in Anti-Asphyxia Valve for breathing fresh air during positive air pressure device failure. |
| Connect to conventional air delivery hose via standard conical connectors | Both masks connect to conventional air delivery hose via standard conical connectors (ISO 5356-1). |
| Fabricated using materials deemed safe (ISO 10993) | All components of both masks are fabricated using materials deemed safe (ISO 10993). |
| Compatible with CPAP or Bilevel therapy | Use of Full Face Masks with CPAP or Bilevel therapy is clinically proven and accepted. |
| Pressure flow characteristics | Substantially equivalent to predicate device. |
| Functional dead-space | Substantially equivalent to predicate device. |
| Physical dead space | Substantially equivalent to predicate device. |
| Flow impedance | Substantially equivalent to predicate device. |
| Reusability in hospital/institutional environment | Both new and predicate devices can be reused in hospital/institutional environment. |
| Sterilization compatibility (new device has additional method) | New device is compatible with an additional method of sterilization compared to predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an AI/CADe test set. The submission refers to "bench testing" of the physical device and a comparison of its characteristics to predicate devices. The exact number of units or test conditions used for this bench testing is not specified.
- Data Provenance: Not specified, but generally, bench testing would be conducted in a laboratory environment, likely by the manufacturer (ResMed Ltd, Australia).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The ground truth for this device is based on established engineering and physiological requirements for respiratory masks and the performance of predicate devices. Expert consensus in the clinical interpretation sense (e.g., radiologists reviewing images) is not relevant here. The clinical efficacy of FFM with CPAP/Bilevel therapy is stated as "Clinical Data proven technology and is well accepted by the medical community."
4. Adjudication method for the test set
- Not Applicable. There is no "test set" in the sense of clinical cases requiring adjudication. The assessment is a direct comparison of physical and functional characteristics.
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. This is a physical medical device (a mask), not an AI/CADe system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (a mask), not an AI/CADe system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is implicitly based on:
- Engineering standards: e.g., ISO 5356-1 for connectors, ISO 10993 for material safety.
- Physiological requirements: Effective CO2 washout, proper seal, anti-asphyxia mechanism.
- Performance of legally marketed predicate devices: The "substantial equivalence" framework means the predicate devices' performance serves as the benchmark.
- Accepted medical practice: "Use of Full Face Masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community."
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is for a physical device, not an AI/CADe system using machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set.
§ 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).