(155 days)
The Mercury CPAP is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
The Mercury CPAP is a respiratory aid device intended for use with a facemask and gas supplying device to elevate pressure in the patient's lungs. Alternatively the device may be used in conjunction with an endotracheal tube to generate and maintain constant positive airway pressure during standard intubation procedures.
The Mercury CPAP device is considered substantially equivalent to its predicate device (Vygon Boussignac CPAP - K013884) based on comparative performance testing. The acceptance criteria are implicit in the comparison to the predicate device's performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (based on predicate Vygon Boussignac CPAP - K013884) | Reported Device Performance (Mercury CPAP) |
|---|---|---|
| Indications for Use | Identical to predicate: Provide CPAP to spontaneously breathing patients in hospital and pre-hospital environment. | Identical to predicate. |
| Technology | Similar technology used to generate CPAP pressure. | Similar technology used to generate CPAP pressure. |
| Materials | Materials in patient contact are identical to predicate devices. | Materials in patient contact are identical to predicate devices. |
| Environment of Use | Identical to predicate: Hospital and pre-hospital. | Identical to predicate. |
| Gas flow provided by | Wall gas or cylinder. | Wall gas or cylinder. |
| Requires a flow meter with ~30 Lpm range | Yes. | Yes. |
| Typical flow rate range | 10-25 lpm. | 10-25 lpm. |
| CPAP pressure range | Up to 10 cm H₂O. | Up to 10 cm H₂O. |
| In-line pressure manometer | Recommended: a manometer be connected. | Integral manometer (Mercury K954486). |
| Excessive pressure relief | No excessive pressure relief (for predicate). | Integrated pop-off at 25 cm H₂O. |
| Patient interface | Face mask with head harness, connects to ET tube with adapter. | Face mask with head harness, connects to ET tube without adapter. |
| Single patient use, disposable | Yes. | Yes. |
| Contraindications and Warnings | None. | None. |
| Comparative Flow vs. CPAP Pressure | Comparable to predicate results. | Demonstrated substantial equivalence. |
| Performance of pressure relief valve | Comparable to predicate (though predicate had none, Mercury CPAP tested its own integral valve). | Demonstrated substantial equivalence (for the Mercury CPAP's integral valve). |
2. Sample size used for the test set and the data provenance
The document states "We have performed comparative performance testing, Comparative Flow vs. CPAP Pressure" and "Performance of the pressure relief valve." However, specific sample sizes for these tests are not provided in the summary. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies the testing was conducted by or for Mercury Medical, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or not provided. The study is a comparative performance test of a medical device (CPAP machine) against a predicate device, focusing on physical and performance characteristics like gas flow, pressure, and mechanical features. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the typical sense (e.g., image interpretation by radiologists).
4. Adjudication method for the test set
This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation where disagreements need to be resolved. This study focuses on device performance metrics.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study concerns the physical and performance characteristics of a CPAP device, not an AI or diagnostic imaging system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not an AI-driven device, and therefore the concept of "algorithm only" or "human-in-the-loop" performance is not relevant. The testing performed was on the physical device itself.
7. The type of ground truth used
The "ground truth" for this type of device comparison is the established performance characteristics and specifications of the predicate device (Vygon Boussignac CPAP - K013884), as well as engineering standards for CPAP functionality and safety. The Mercury CPAP's performance was compared against these established benchmarks.
8. The sample size for the training set
This information is not applicable. This is a hardware medical device and does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
§ 868.5965 Positive end expiratory pressure breathing attachment.
(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).