(96 days)
The Mirage FX channels airlow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system.
The Mirage FX is:
- to be used by 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 FX 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 FX is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage FX is a prescription device supplied non-sterile.
Here's an analysis of the acceptance criteria and study information for the RESMED Mirage FX Traditional 510k submission, based on the provided text:
Acceptance Criteria and Device Performance
The submission describes the Mirage FX device as "substantially equivalent" to predicate devices, meaning it meets the same safety and effectiveness standards. The specific criteria are based on the technological characteristics and performance of the predicate devices.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance (Mirage FX) |
|---|---|---|
| Intended Use | Identical intended uses to predicate devices. Indicated for the same user population. | "The new device and the predicate mask have identical intended uses. Both devices are indicated for the same user population." (Comparison with predicate ComfortLite 2) |
| Technology Characteristics (Seal) | Provide a seal via a silicone interface. | "Both masks provide a seal via silicone interface." (Comparison with predicate Mirage Micro) |
| Technology Characteristics (Fit) | Offered in various sizes to ensure adequate fit over the extended patient population. | "Both the new and predicate masks are offered in various sizes to ensure adequate fit over the extended patient population." (Comparison with predicate Mirage Micro) |
| Technology Characteristics (CO2 Rebreath) | Incorporate vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed by the patient, without interfering with intended performance. | "Both masks incorporate vent holes to provide continuous air leak to flush out and minimize the amount of CO2 rebreathed by the patient. The design of the mask components is such that the incorporation of these vent-holes does not interfere with the intended performance of the masks." (Comparison with predicate Mirage Micro) |
| "The CO2 performance of the Mirage FX has been demonstrated through bench testing to be substantially equivalent to the Ultra Mirage II." (Comparison with predicate Ultra Mirage II) | ||
| Technology Characteristics (Hose Connection) | Connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1:2004). | "Both masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1:2004)" (Comparison with predicate Mirage Micro) |
| Technology Characteristics (Materials) | Constructed using molded plastic and silicone components and fabric/nylon headgear. Materials deemed safe (ref: ISO 10993-1). | "Both the new and predicate devices are constructed using molded plastic and silicone components and fabric / nylon headgear. Components of the new and predicate masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." (Comparison with predicate Mirage Micro) |
| Non-clinical Performance (Pressure-Flow) | Pressure-flow characteristics and flow impedance are substantially equivalent to the predicate device. | "The pressure-flow characteristics and flow impedance of the new devices was bench tested and demonstrated to be substantially equivalent to the predicate device." (Comparison with predicate Mirage Micro) |
| Non-clinical Performance (Reuse) | Reusable in home and hospital/institution environment. | "Both the new and the predicate devices can be reused in the home and hospital / institution environment." (Comparison with predicate Mirage Micro) |
| Safety and Effectiveness | Does not raise new questions of safety and effectiveness; at least as safe and effective as predicate devices. | "Mirage FX is substantially equivalent to the predicate devices...- it does not raise new questions of safety and effectiveness; - it is at least as safe and effective as the predicate devices." |
Study Information
Based on the provided text, the submission primarily relies on bench testing and comparison to predicate devices to demonstrate substantial equivalence. No clinical studies (on human subjects) are described in detail.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The evaluation primarily involved bench testing of the device itself and comparison to physical characteristics of predicate devices.
- Data Provenance: Not applicable in the context of a clinical test set. The bench testing would have been conducted by ResMed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth for a clinical test set (e.g., disease presence) was not established through expert review for this submission. The "ground truth" for the device's performance was established through engineering specifications and comparison to the performance of medically accepted predicate devices via bench testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring expert adjudication.
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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
- No MRMC study was mentioned. This device is a medical mask for positive airway pressure therapy, not an AI-assisted diagnostic or treatment device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device. The "standalone" performance refers to the bench testing of the device's physical functions (e.g., pressure-flow characteristics, CO2 clearance) without a human user.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this substantial equivalence claim is effectively the established safety and effectiveness of the predicate devices and the physical/engineering standards (e.g., ISO standards, pressure-flow characteristics) achieved through bench testing. For CO2 performance, it was deemed "substantially equivalent" to the Ultra Mirage II.
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The sample size for the training set
- Not applicable. This device does not involve machine learning algorithms that require a "training set."
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How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning algorithms.
§ 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).