(58 days)
The Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.
Mirage FFM Series 2 is a respiratory mask covering the nose and the mouth. It is a patient interface accessory for use with CPAP and bi-level devices.
The provided text describes the ResMed Mirage Full Face Mask (FFM) Series 2 and its substantial equivalence to a predicate device, focusing on disinfection methods. It does not contain information typically associated with acceptance criteria and studies proving performance for a diagnostic AI/ML device, such as sensitivity, specificity, or clinical outcome studies.
Therefore, many of the requested fields cannot be filled. The information available pertains to the device's technological characteristics and its validation for disinfection.
Here's an attempt to answer based on the provided text, highlighting where information is unavailable or not applicable to the format requested for AI/ML device studies:
| Acceptance Criteria (Not explicit for performance, but for disinfection validation) | Reported Device Performance (Disinfection Validation) |
|---|---|
| Withstand 15 cycles of high-level disinfection for semi-critical components | Mirage FFM Series 2 semi-critical mask components can withstand 15 cycles of high-level disinfection using: |
| - 3.4% glutaraldehyde solution (e.g., Cidex Plus) | |
| - 0.08% peroxyacetic acid and 1% hydrogen peroxide (e.g., Cidex PA) | |
| - 0.55% ortho-phthalaldehyde solution (e.g., Cidex OPA) |
Additional Information based on the text:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical mask components undergoing disinfection cycles, not a dataset for an AI/ML model. No specific sample size (e.g., number of masks, components) is mentioned for the disinfection validation beyond "components can withstand 15 cycles." Data provenance is not relevant in this context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for disinfection validation involves laboratory testing against established chemical and biological standards, not expert consensus interpreting data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for human interpretation differences in diagnostic tasks.
- 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 not an AI/ML diagnostic device; it's a medical mask.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For disinfection validation, the ground truth would be established through microbiology laboratory testing to confirm the effectiveness of disinfection agents against specified microorganisms and material integrity testing to ensure the components withstand the disinfection cycles without degradation.
- The sample size for the training set: Not applicable. This is not an AI/ML device; there is no training set mentioned.
- How the ground truth for the training set was established: Not applicable. 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).