(150 days)
The Mirage Micro 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 Micro is:
- to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.
- intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.
The Mirage Micro provides seal such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.
Mirage Micro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
Mirage Micro is a prescription device supplied nonsterile.
The provided text is a 510(k) summary for the ResMed Mirage Micro, a vented nasal mask. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with acceptance criteria and a comprehensive study report. Therefore, much of the requested information regarding specific acceptance criteria, test sets, experts, and detailed study methodologies is not present in the provided text.
Here is the information that can be extracted or reasonably inferred from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments / Context |
|---|---|---|
| Intended Use Equivalence | Same intended use as predicate device | The modified device "has the same intended use" as the predicate Mirage Micro Mask (K072940). |
| Technological Characteristics Equivalence | Similar technological characteristics to predicate device | Both devices provide seal via dual wall silicone interface, are offered in various sizes, incorporate vent holes for CO2 flushing, connect to conventional air delivery hoses via standard conical connectors, have provisions for connecting oxygen and pressure sensing tubing via luer ports, and are constructed with molded plastic components and fabric headgear using materials deemed safe. |
| Safety and Effectiveness | Does not raise new questions of safety and effectiveness; at least as safe and effective as the predicate | Stated explicitly as a conclusion for substantial equivalence. |
| CO2 Performance | Substantially equivalent to predicate device | Bench testing was used to demonstrate this. |
| Pressure-Flow Characteristics & Flow Impedance | Substantially equivalent to predicate device | Both devices are designed to operate on the same standard flow generator setting, and their pressure-flow characteristics and flow impedance are substantially equivalent. Bench testing was used to demonstrate this. |
| Material Biocompatibility | All components, including the modification to the swivel color, are fabricated using materials deemed safe (ref: ISO 10993-1). | This is a general safety criterion for medical devices. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Micro, as was the case with the predicate devices."
- Sample Size for Test Set: Not specified. Since it refers to "bench testing," it would involve testing physical prototypes or samples rather than human subjects. The number of masks tested is not provided.
- Data Provenance: Bench testing results. Country of origin is not specified, but the applicant (ResMed) is a global company. Based on the submission being to the FDA, it's likely the testing was conducted in a manner consistent with US regulatory requirements, potentially in the US or by a facility accredited for such testing. The testing is prospective in the sense that it was performed to support this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a bench testing study comparing the modified device to a predicate device based on physical characteristics and performance measurements (CO2, pressure-flow). There was no "ground truth" derived from expert interpretation of images or clinical outcomes in the traditional sense that would require a panel of experts.
4. Adjudication method for the test set
Not applicable, as no expert review or adjudication of clinical data was performed. The evaluation relied on objective measurements from bench testing.
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 device is a medical mask for respiratory support, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the performance data (CO2, pressure-flow, flow impedance), the "ground truth" would be established by the objective measurements obtained from the bench testing against predefined engineering specifications and comparison to the predicate device's performance. For biocompatibility, the ground truth refers to compliance with ISO 10993-1 standards using validated material testing methods.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established
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).