(100 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 and 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 describes the 510(k) summary for the ResMed Mirage Micro™ nasal mask. This document outlines the device's characteristics and its substantial equivalence to predicate devices, rather than a clinical study demonstrating the device meets specific acceptance criteria through comprehensive performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not present in this regulatory submission for a nasal mask. The submission emphasizes "bench testing" and "proven technology" for substantial equivalence.
Here's an analysis based on the information available and not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it relies on a comparison to predicate devices, asserting "substantial equivalence" in key performance characteristics relevant to its function as a nasal mask for PAP therapy.
| Performance Characteristic (Implied "Acceptance Criteria") | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Seal (adequate for airflow from positive pressure source) | "The Mirage Micro provides seal such that airflow from a positive pressure source is directed to the patient's nose." |
| Fit (over extended patient population) | "Both masks are offered in various sizes to ensure adequate fit over the extended patient population." (Compared to Ultra Mirage II) |
| CO2 Rebreathing / Vent Holes (minimize CO2 rebreathing and flush dead space) | "The design of the mask components is such that the incorporation of these vent holes do not interfere with the intended performance of the masks." (Compared to Ultra Mirage II) |
| "The CO2 performance the new device and the predicate device are substantially equivalent." | |
| Connection to Air Delivery Hose (standard conical connectors) | "Both the masks connect to conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1:2004)" (Compared to Ultra Mirage II) |
| Oxygen/Pressure Sensing Ports (luer ports) | "Both the masks have provisions for connecting oxygen and pressure sensing tubing via luer ports." (Compared to Ultra Mirage II) |
| Biocompatibility of Materials (fabricated using safe materials) | "All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." (Compared to Ultra Mirage II) |
| Pressure-Flow Characteristics / Flow Impedance | "The pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent." (Compared to Meridian) |
| Safety and Efficacy | "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Micro, as was the case with the predicate devices." (Clinical data section explicitly states this) |
| Intended Use (adult patients, single patient reuse, home/hospital environment) | "Same intended use with reduced scope being for single patient reuse" (compared to predicate Ultra Mirage II for multi-patient use in hospital/institutional environment) |
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." This indicates that the primary performance evaluation was conducted via bench testing, meaning in a laboratory setting, rather than with human subjects in a clinical trial.
- Sample size: Not specified for bench tests. For physical component characteristics, it would likely involve a sample of manufactured masks.
- Data provenance: Bench test data, not explicitly described as from a specific country, but linked to internal testing by ResMed Ltd (Australia). The data provenance is retrospective in the sense that it's based on internal validation for product development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As the evaluation was based on bench testing and comparison to predicate devices, there was no "ground truth" derived from expert interpretation of clinical data in the traditional sense. The "ground truth" for performance would be the specifications and validated behavior of the predicate devices and general knowledge of CPAP mask function.
4. Adjudication method for the test set
Not applicable. No expert adjudication method is described, as it was 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, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical mask, not an algorithm. Its "standalone" performance refers to its physical and functional characteristics on a bench.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance is based on engineering specifications, material safety standards (ISO 10993-1), recognized international standards for connectors (ISO 5356-1:2004), and the established performance characteristics of the predicate devices. It’s not clinical ground truth like pathology or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved 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).