(424 days)
The Boussignac® C.P.A.P. Device is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
The Boussignac® C.P.A.P. Device is a sterile, single-use, respiratory aid device intended for use with a facemask and gas-supplying device to elevate pressure in a patient's lung. Alternatively, the device may be used in conjunction with an endotracheal tube (via a specific Vygon adapter) to generate and maintain constant positive airway pressure during standard intubation procedures.
The upper, or proximal, port of the device may be connected to a gas-supplying source via an attached connecting tube, while the lower, or distal port may provide for C.P.A.P. pressure monitoring, O2 monitoring, or an additional source of oxygen in the event that the gas administered to the patient via the proximal connection is air not enriched with oxygen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Boussignac® C.P.A.P. Device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Description | Reported Device Performance (Summary of Non-Clinical Tests / Conclusions) |
|---|---|
| Pressure decrease with inhalation is not excessive. | Data demonstrated that pressure decrease with inhalation is not excessive. |
| Pressure increase with exhalation is not excessive. | Data demonstrated that pressure increase with exhalation is not excessive. |
| Pressure decrease with inhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. | Data demonstrated that pressure decrease with inhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. |
| Pressure increase with exhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. | Data demonstrated that pressure increase with exhalation is not excessive when an adult bronchoscope is introduced into the device's free-air end. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "non-clinical tests" and explicitly states "Summary of Clinical Tests (Not Applicable)." This indicates that the performance evaluation was based on bench testing/laboratory experiments, not on a test set of patient data. Therefore, questions regarding patient sample size, country of origin, or retrospective/prospective nature are not directly applicable to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As the study was non-clinical (bench testing), there were no patient "cases" or ground truth established by medical experts in the traditional sense. The "ground truth" for these tests would likely be established metrics or engineering specifications for pressure changes.
4. Adjudication Method for the Test Set
Not applicable. Since there were no expert assessments of patient data, there was no need for an adjudication method.
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. The document explicitly states "Summary of Clinical Tests (Not Applicable)," meaning no clinical studies, including MRMC studies, were performed. This device is not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, in a sense. The "non-clinical tests" represent the standalone performance of the device itself (not an algorithm in this context). The device was tested in a controlled environment to ensure it met specific physical performance criteria related to pressure regulation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" would be engineering specifications or established physical parameters for acceptable pressure variations in CPAP devices, likely derived from industry standards or a comparison to predicate devices. The document implies these tests demonstrate equivalence to predicate devices, suggesting the predicate device's performance characteristics served as a reference.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical respiratory aid, not an algorithm-based device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
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).