(147 days)
The small size AF531 SE Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients 7 years or older (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.
The Respironics AF531 SE Full Face Mask consists of a silicone cushion, polycarbonate faceplate with a standard elbow with no exhalation, requiring the use of a separate exhalation device. This mask is an accessory for use with ventilators in the hospital/institutional environment only. The small size AF531 SE Full Face Mask will be used on patients 7 years or older (> 40 lbs/20kg).
The Respironics AF531 SE Full Face Mask is a medical device for noninvasive ventilation. The provided text describes its acceptance criteria and the study conducted to prove it meets them.
1. Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | The mask is intended to provide a patient interface for application of noninvasive ventilation in a hospital/institutional environment for patients aged 7 years or older (>40lbs/20kg). |
| Environment of Use | Hospital/institutional environment only. |
| Patient Population | Patients 7 years or older (> 40 lbs/20kg). |
| Ventilator Compatibility | To be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory insufficiency or obstructive sleep apnea. |
| Performance Testing | - Pressure Performance: Not explicitly detailed, but implied to be sufficient for non-invasive ventilation. |
- Waveform Performance: Not explicitly detailed, but implied to be compliant with ventilation requirements.
- Triggering, Cycling, and Alarm Functionality: Implied to be compatible and functioning correctly with ventilators.
- Safety and Effectiveness: No new issues of safety or effectiveness identified. |
| Material/Design | Silicone cushion, polycarbonate faceplate, standard elbow (requiring separate exhalation device), uses Four Points Headgear design (CapStrap headgear also compatible). |
| Usage | Single use only. |
Reported Device Performance:
The document states: "The modified device has been performance tested with passing results. Test protocols including pressure performance, waveform performance, triggering, cycling and alarm functionality testing along with the results of these tests are provided in Tab 8 of this submission." And, "The small size AF531 SE Full Face Mask was performance tested and verified to meet the required acceptance criteria. Results of this testing concluded that the verification testing raises no new issues of safety or effectiveness."
2. Sample Size and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described appears to be technical bench testing of the device's physical and functional properties rather than clinical data from human subjects.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided in the document. Given that the testing focuses on the device's physical and functional performance (pressure, waveform, triggering, etc.), it's likely that engineers and technical experts in ventilation equipment would have been involved, rather than medical experts establishing ground truth for diagnostic accuracy.
4. Adjudication Method
The document does not specify any adjudication method for a test set. This type of method is typically used in studies involving subjective interpretation (e.g., image analysis for diagnosis), which is not the nature of the described testing for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted involving human readers with or without AI assistance. This type of study is not relevant to the evaluation of a face mask for non-invasive ventilation.
6. Standalone Algorithm Performance
This device is a physical medical device (a face mask), not an algorithm or AI system. Therefore, the concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by technical specifications and functional output (e.g., measured pressure, waveform characteristics, appropriate triggering/cycling, alarm functionality) as per engineering and regulatory standards for ventilator accessories. It is not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on whether the device meets its defined technical performance parameters.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI algorithm development. Since this is a physical medical device and not an AI system, there is no training set in the conventional sense. The "training" for such devices involves design, prototyping, and iterative testing to ensure it meets specifications.
9. How Ground Truth for the Training Set was Established
As there is no "training set" for this physical device, the question of how its ground truth was established is not applicable. The design and development process for such a device relies on engineering principles, material science, and established standards for medical device safety and performance.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).