(80 days)
The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home environment or multi-patient, multi-use in the hospital/institutional environment.
The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a multi-patient, multi- use accessory for use with CPAP or bi-level devices. The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.
The provided text describes the 510(k) summary for the "Comfort Twin Nasal Mask - Multi-Patient, Multi-Use". It focuses on establishing substantial equivalence to predicate devices and detailing the device's design and intended use, rather than presenting a study with specific quantitative acceptance criteria or detailed performance metrics against those criteria.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Device is an accessory to a non-continuous ventilator for adult patients prescribed CPAP or bi-level therapy. Intended for single-patient reuse (home) or multi-patient, multi-use (hospital/institutional). | The Comfort Twin Nasal Mask shares the "Same intended use" as the predicate device. |
| Operating Principle: Same operating principle as predicate. | The Comfort Twin Nasal Mask shares the "Same operating principle" as the predicate device. |
| Technology: Same technology as predicate. | The Comfort Twin Nasal Mask shares the "Same technology" as the predicate device. |
| Manufacturing Process: Same manufacturing process as predicate. | The Comfort Twin Nasal Mask shares the "Same manufacturing process" as the predicate device. |
| Performance with cleaning/disinfection (Cidex): Exposure to specified cleaning and disinfection agent (Cidex) does not degrade performance. | "The results of this testing confirm that exposure to the specified cleaning and disinfection agent (Cidex) does not degrade the performance of the Comfort Twin Nasal Mask." |
| Mask Efficacy Testing (Cleaning Method): Cleaning method specified in the cleaning and disinfection guide is effective. | All mask materials in contact with Cidex "have been tested by an independent laboratory to confirm efficacy of the cleaning method". |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the performance tests.
- Data Provenance: Not specified, but the testing was internal ("Performance testing has been carried out to verify the safety & effectiveness...") and for mask efficacy testing, "tested by an independent laboratory". It does not mention country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here refers to physical performance characteristics and cleaning efficacy, not interpretations made by experts in a diagnostic context.
4. Adjudication method for the test set:
- Not applicable. No expert adjudication process is described for physical performance and cleaning efficacy tests.
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:
- Not applicable. This device is a medical accessory (nasal mask), not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device. Performance testing focused on the physical device's characteristics and its ability to withstand cleaning.
7. The type of ground truth used:
- For performance with cleaning/disinfection: The "ground truth" would be established by objective measurements of material integrity and device function after exposure to Cidex, likely against pre-defined engineering specifications.
- For mask efficacy testing (cleaning method): The "ground truth" would be the demonstrated removal or inactivation of specified microorganisms or contaminants, measured by an independent laboratory.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).