(266 days)
This product is a single-patient-use device that delivers respiratory gases to adult patients in hospitals and long-term care facilities.
This product is indicated for the delivery of Nasal High Flow (NHF) and Low Flow Oxygen to spontaneously breathing patients by appropriately qualified healthcare professionals.
Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.
This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist.
This product is not intended for apneic ventilation.
The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a medical device intended to deliver respiratory gases to the patient and provide a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer. The device is offered in three sizes being small (S), medium (M) and large (L). The F&P Optiflow™ Nasal Oxygen Cannula with CO2 Sampling is a prescription only device, provided in a non-sterile state.
The requested information, based on the provided document, is as follows:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics alongside reported numerical device performance values in the way one might expect for a diagnostic or AI device. Instead, it describes a series of non-clinical performance tests conducted to ensure safety and effectiveness and demonstrate substantial equivalence. The 'reported device performance' is generally stated as having met the requirements or demonstrating functionality.
Here's a summary of the performance tests performed, which imply the acceptance criteria were met if the tests were successful:
| Test Category | Implied Acceptance Criteria (Met if successful) | Reported Device Performance |
|---|---|---|
| Shelf Life Testing (as per ASTM F1980-16) | Product requirements continue to be met after 18 months of storage. | Demonstrated product requirements continue to be met after 18 months. |
| Transportation Testing (as per ISTA 2A:2011) | Device integrity and functionality maintained after transportation. | Performed following transportation to ISTA 2A:2011. |
| Nasal Cannula Leak Test | No unacceptable leaks. | Completed. |
| CO2 Sampling Tube Leak Test | No unacceptable leaks. | Completed. |
| Resistance to flow of the CO2 Sampling Tube | Resistance within acceptable limits. | Completed. |
| Resistance to flow during compression of the CO2 Sampling Tube | Resistance within acceptable limits during compression. | Completed. |
| Functional Requirements Testing | Functional requirements met after transport, storage, simulated use. | Performed to ensure functional requirements were met. |
| Strength Testing of CO2 Sampling Tube's permanent connections | Connections maintain strength after transport, storage, simulated use. | Performed after transport, storage, and simulated use conditioning. |
| CO2 Sampling functionality validation | Device accurately samples CO2 as intended. | Performed to validate the device's CO2 Sampling functionality. |
| Usability testing | CO2 Sampling feature and related warnings/directions for use are usable. | Conducted on the use of the CO2 Sampling feature and warnings/directions. |
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 describes non-clinical performance data (laboratory testing) rather than clinical study data involving patient samples in the typical sense of a "test set" for a diagnostic device. Therefore, a "sample size for the test set" is not applicable in this context. The tests were performed on the device itself and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes laboratory-based performance testing, not a study requiring expert-established ground truth from medical images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as it refers to performance testing of a physical device against engineering specifications and standards, not a diagnostic assessment by multiple readers.
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 is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance tests are the engineering specifications, relevant ISO standards (e.g., ISO 594-2, ISO 5356-1, ISO 5361, ISO 10993-1, ISO 18562-1), and the device's own design requirements. For example, a leak test would compare the device's leak rate to an acceptable industry standard or internal specification.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).