(273 days)
The FaceFit Ported Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.
The Intersurgical FaceFit Ported NIV Mask provides a seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. The Intersurgical Face Fit Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. FaceFit Ported Mask with a CO2 port for use with BIPAP and CPAP machines. The FaceFit Ported Mask features an anti-asphyxiation valve that will allow patients using a CPAP or BIPAP machine to breathe spontaneously through the mask in the event of a machine failure or system disconnection. The FaceFit ported mask is available in small, medium and large sizes.
The Intersurgical FaceFit Ported NIV Mask (K121747) was cleared based on substantial equivalence to the Resmed Mirage Full Face Mask (K063011). The device is a non-invasive ventilation mask intended to channel airflow from a positive airway pressure device to a patient.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by demonstrating similar performance characteristics to the predicate device. The following table summarizes key performance characteristics compared between the proposed device and the predicate device:
| Characteristic Compared | Predicate Device (Resmed Mirage Full Face Mask K063011) | Proposed Device (FaceFit Mask with CO2 Port) | Acceptance Criteria/Performance |
|---|---|---|---|
| CO2 Rebreathing (%) | 2.14 (PCP Open) / 2.06 (PCP Closed) | 0.79 (PCP Open) / 0.96 (PCP Closed) | Proposed device's CO2 rebreathing should be comparable to or lower than the predicate device. The proposed device shows lower CO2 rebreathing, indicating superior performance in this aspect. |
| Patient Respiratory Resistance mb. PCP Open | 0.0 (Inhalation) / 0.1 (Expiration) With a Peak Flow of 20 l/min | 0.0 (Inhalation) / 0.0 (Expiration) With a Peak Flow of 20 l/min | Proposed device's respiratory resistance should be comparable to or lower than the predicate device. Both devices show similar, low resistance. |
| Patient Respiratory Resistance mb. PCP Closed | 0.1 (Inhalation) / 0.0 (Expiration) With a Peak Flow of 20 l/min | 0.0 (Inhalation) / 0.0 (Expiration) With a Peak Flow of 20 l/min | Proposed device's respiratory resistance should be comparable to or lower than the predicate device. Both devices show similar, low resistance. |
| Valve Function Close | 59 l/min flow at 0.7 mb pressure | 58 l/min flow at 1.5 mb pressure | Proposed device's valve function should be comparable to the predicate device. The parameters are close, but the proposed device closes at a slightly higher pressure, which may indicate a more robust seal in certain conditions. |
| Valve Function Open | 16.8 l/min flow at 0.4 mb pressure | -0.1 mb pressure | Proposed device's valve function should be comparable to the predicate device. The proposed device opens at a slightly negative pressure, indicating it opens easily in low-pressure conditions. |
| Volume ml. | 174 | 123 | The proposed device has a smaller internal volume, which is generally desirable for NIV masks as it can reduce rebreathing potential. This is a beneficial difference compared to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "sample size" in terms of number of patients or masks tested for the performance evaluations. Instead, the testing appears to be based on a comparison of technical specifications and measured physical characteristics of the device and its predicate.
The data provenance is not explicitly stated, but as this is a premarket notification to the FDA, it is expected that the testing was conducted by the manufacturer (Intersurgical Incorporated) likely in the country of origin of the manufacturer or in accredited testing facilities. The specific type of study (retrospective or prospective) is not applicable here as these are laboratory/bench tests, not clinical evaluations on human subjects for performance comparison against the predicate.
3. 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)
This information is not applicable. The "ground truth" for this device's performance metrics (CO2 rebreathing, respiratory resistance, valve function, volume) is established through standardized engineering and laboratory testing, not through expert clinical consensus or interpretation as would be the case for diagnostic imaging AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the "test set" in this context refers to laboratory performance measurements, not clinical interpretation or diagnostic outcomes requiring adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human interpretation, not for physical medical devices like NIV masks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI does not apply. The performance data provided are inherent to the device's physical design and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance characteristics of the NIV mask is derived from objective, quantitative measurements in a laboratory setting based on established engineering and physiological testing standards (e.g., measuring CO2 rebreathing as a percentage, respiratory resistance in millibars, and valve flow rates). This is analogous to "bench testing" data rather than clinical ground truth obtained from patients or experts.
8. The sample size for the training set
This information is not applicable. This device is a physical product and does not involve machine learning or AI algorithms with "training sets."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 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).