(73 days)
The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.
Mirage Activa™ is a respiratory nasal mask using a dual cushion design with built-in bellows. It is a multiple-patient, multiple-use interface accessory for use with CPAP or bi-level devices.
The provided text describes a 510(k) premarket notification for the ResMed Mirage Activa™ Mask, seeking clearance for its use as a multiple-patient, multiple-use device. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly regarding disinfection and reuse protocols.
Here's an analysis of the acceptance criteria and study data, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to withstand multiple reprocessing cycles for disinfection/sterilization. | ResMed developed specific protocols for validating multiple-patient use, following AAMI TIF No. 12-1994. These protocols were reviewed and validated for the Full Face Mask Series 2 (K023244, K023284, K023306), which are predicate devices. The Mirage Activa™ mask intends to use the same Disinfection Guide provided for the predicate devices. This implies the device is designed to withstand these validated disinfection procedures. |
| Maintenance of functional performance post-reprocessing. | Not explicitly stated as a separate criterion or performance metric, but implied by the overall conclusion of substantial equivalence for multiple-patient, multiple-use. |
| Biocompatibility and safety after reprocessing. | Not explicitly stated as a separate criterion or performance metric in relation to this specific submission, but implied by the general regulatory requirements for medical devices. The use of validated disinfection protocols (likely including residue testing) would address this. |
| Substantial equivalence to predicate device for multiple-patient, multiple-use. | The conclusion states: "The Mirage Activa™ mask is substantially equivalent to the previously cleared predicate masks and can be relabeled for multiple-patient, multiple-use." This is the primary reported "performance" in the context of the regulatory submission. |
Crucially, the document does not provide quantitative performance metrics (e.g., specific disinfection efficacy logs, number of cycles tested, or mechanical integrity after x cycles) for the Mirage Activa™ mask itself. Instead, it relies on the validation of the protocols against predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "specific protocols for validating multiple-patient use" developed by ResMed and validated for the Full Face Mask Series 2. It does not mention a specific number of masks or test cycles performed for the Mirage Activa™ mask in this summary.
- Data Provenance: The document does not specify the country of origin for the validation data. It refers to ResMed, which has a US address as the submitter, so it could be assumed the validation was conducted or overseen in the US, following AAMI standards. The data is retrospective in the sense that the protocols were developed and validated for previous devices (Full Face Mask Series 2) and are now being applied to the Mirage Activa™ mask. The text does not describe a new, prospective study specifically for the Mirage Activa™ mask involving human patients or extensive lab testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of submission (device reprocessing validation) does not typically involve expert review of clinical images or patient data to establish "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the efficacy of the disinfection protocols as per AAMI standards. The document mentions that the protocols were "reviewed and validated" but does not specify who performed this review and validation (e.g., internal ResMed experts, external lab personnel, regulatory body representatives).
4. Adjudication Method for the Test Set
Not applicable for this type of device validation study.
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 not a diagnostic AI device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an accessory device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the validation of disinfection protocols against recognized standards (AAMI TIF No. 12-1994) for achieving a specified level of microbial inactivation and material compatibility. This is generally established through laboratory testing (e.g., inoculated samples, residue analysis, material degradation studies) on devices subjected to the reprocessing cycles. The document implies that this ground truth was established for the predicate devices, and the Mirage Activa™ mask is expected to perform similarly due to substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a 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).