(90 days)
Intended for use where monitoring airway pressure is desired by providing a visual indication of airway pressure and may be used on all patient populations in the hospital, post-hospital and home care environments
Intended for use where monitoring airway pressure is desired. This device provides a visual indication of airway pressure and may be used on all patient populations in the hospital, pre-hospital, post-hospital and home care environments.
Single patient use mechanical pressure manometer indicator compresses a spring to a position where the force exerted by the gas equals the force exerted by the compressed spring combinations and graduated marking on individual housings allow the device to be offered in 0 - 60 cm H2O and 0 - 15 cm H2O pressure ranges.
The A Plus Medical VentiPlus™ Disposable Pressure Manometer is compared against an electronic pressure measurement device to assess its accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of pressurement | ± 0.1 cm H2O (against electronic pressure measurement device) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set (number of devices tested or readings taken).
Data provenance: The testing appears to be in-house bench testing conducted by A Plus Medical. No information is provided regarding the country of origin of the data or if 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 was established using an "electronic pressure measurement device," which is a piece of equipment, not human experts.
4. Adjudication method for the test set
Not applicable. The ground truth was established by an electronic device, not human experts, so no adjudication method was required.
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, an MRMC comparative effectiveness study was not done. This device is a mechanical pressure manometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance test was done. The device's accuracy was tested against an electronic pressure measurement device without direct human interaction being part of the measurement process itself beyond initiating and observing the test.
7. The type of ground truth used
The ground truth used was measurements from an "electronic pressure measurement device."
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning algorithm, therefore, there is no training set.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no training set for this type of device.
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).