(70 days)
The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.
The Mirage Echo provides an interface 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 Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.
Here's an analysis of the Mirage Echo Traditional 510k, based on the provided text, focusing on acceptance criteria and supporting studies.
Based on the provided information, the 510(k) submission for the Mirage™ Echo nasal mask describes a comparative study against predicate devices (Mirage Micro and Ultra Mirage II Mask) to demonstrate substantial equivalence, rather than a study with explicit, quantitative acceptance criteria for device performance as one might see for an AI algorithm.
The core of the "study" is a set of comparisons and assertions of substantial equivalence, relying on bench testing and the existing clinical acceptance of similar technology.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a traditional 510(k) for a medical device (nasal mask), the "acceptance criteria" are primarily established implicitly by demonstrating substantial equivalence to predicate devices, focusing on safety, performance characteristics, and intended use. The performance is reported as "substantially equivalent" to the predicates.
| Acceptance Criteria (Implied from Substantial Equivalence to Predicates) | Reported Device Performance (Mirage Echo) |
|---|---|
| Safety: Materials deemed safe (ref: ISO 10993-1). | All components are fabricated using materials deemed safe (ref: ISO 10993-1). |
| Intended Use: Channels airflow noninvasively from a PAP device to adult patients (> 66 lb/30 kg) for single-patient home reuse and multipatient hospital/institutional reuse. | Same intended use as predicates. Channels airflow noninvasively to a patient from a PAP device (CPAP/bilevel system), for adult patients (> 66 lb/30 kg), for single-patient home reuse and multipatient hospital/institutional reuse. |
| Technological Characteristics: | |
| - Provides a seal via silicone interface. | Provides a seal via silicone interface. |
| - Offered in various sizes for adequate fit. | Offered in various sizes to ensure adequate fit. |
| - Incorporates vent holes for continuous air leak to flush CO2 and minimize rebreathing without interfering with performance. | Incorporates vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed. The design ensures vents do not interfere with intended performance. |
| - Connects to conventional air delivery hose via standard conical connectors (ISO 5356-1:2004). | Connects to a conventional air delivery hose via standard conical connectors (ref: ISO 5356-1:2004). |
| - Constructed using molded plastic and silicone components. | Constructed using molded plastic and silicone components. |
| - Operates on the same ResMed flow generator settings. | Designed to operate on the same ResMed flow generator settings. |
| - Substantially equivalent pressure-flow characteristics and flow impedance. | Pressure-flow characteristics and flow impedance of both the new device and the predicate device are substantially equivalent. |
| - Can be reused in home and hospital/institution environment. | Can be reused in the home and hospital/institution environment. |
| - CO2 performance is substantially equivalent. | The CO2 performance of the new device and the predicate device are substantially equivalent. |
| Effectiveness: At least as safe and effective as the predicate devices and does not raise new questions of safety and effectiveness. | Asserted to be at least as safe and effective and does not raise new questions of safety and effectiveness. "Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community." "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage ECHO, as was the case with the predicate device." |
2. Sample Size for the Test Set and Data Provenance
The provided text does not mention a "test set" in the context of clinical data or patient-specific evaluation. The performance data refers to bench testing. Therefore, information regarding:
- Sample size for the test set
- Data provenance (e.g., country of origin, retrospective/prospective)
is not applicable as no clinical test set data is described. The submission relies on "bench testing" and comparison of technical specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. Since no clinical test set data is described, there's no mention of experts establishing a ground truth for such a set. The "ground truth" for this type of submission is typically derived from established engineering principles, international standards (e.g., ISO), and the performance of legally marketed predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable. No clinical test set data is described that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, potentially with AI assistance. The Mirage Echo is a medical device (nasal mask) for therapy delivery, not a diagnostic tool requiring interpretation.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done, nor would it be relevant for this type of device. The Mirage Echo is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is established through bench testing results, adherence to international standards (e.g., ISO 10993-1 for biocompatibility, ISO 5356-1:2004 for connectors), engineering specifications, and the established performance and safety profile of legally marketed predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it focuses on demonstrating substantial equivalence in physical and functional characteristics.
8. Sample Size for the Training Set
This information is not applicable. The Mirage Echo is a physical medical device, not an AI algorithm that undergoes a "training set" process.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As it's not an AI algorithm, there is no "training set" or ground truth for such a 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).