(27 days)
The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.
Mirage ActivaTM is a respiratory nasal mask using dual cushion design with built-in bellows. It is a single-patient-use interface accessory for use with CPAP and bi-level devices.
Here's a breakdown of the acceptance criteria and study information for the Mirage Activa™ Mask, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Functional Performance | Pressure-flow characteristic | Equivalent with the predicate mask |
| Dead space (CO2 re-breathing) | Equivalent with the predicate mask | |
| Flow impedance | Equivalent with the predicate mask | |
| Biocompatibility | Materials in contact with skin/air-path are either predicate materials or compliant with ISO 10993 standards. | All materials meet this criterion. |
| Safety and Effectiveness | Changes in design compared to the predicate device do not affect safety and effectiveness. | Concluded as unchanged, supporting substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set. This report focuses on comparing engineering characteristics of the new device to a predicate device, rather than a clinical study with patient data.
The data provenance is not explicitly stated. The tests conducted were likely prospective engineering tests performed by ResMed Ltd. in a lab setting to assess the physical properties of the mask.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is established through engineering and material testing standards (e.g., ISO 10993 for biocompatibility) and direct comparison of functional parameters to a known predicate device. There is no mention of human expert consensus for interpreting test results in the context of clinical "ground truth."
4. Adjudication Method for the Test Set
This is not applicable here as there is no mention of a human expert panel or adjudication process for the engineering test results.
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
This is not applicable. The Mirage Activa™ Mask is a physical medical device (a nasal mask) and does not involve AI or human readers in the context of image interpretation or diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical nasal mask, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the functional performance criteria (pressure-flow, dead space, flow impedance), the "ground truth" is established by engineering measurements against pre-defined specifications and direct comparison to the physical characteristics of the predicate device.
For biocompatibility, the "ground truth" is established by compliance with ISO 10993 standards and the use of previously cleared materials.
8. The Sample Size for the Training Set
This is not applicable. The Mirage Activa™ Mask is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
§ 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).