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The Gio Digital Manometer is intended for used on all patient populations to measure airway pressure in respiratory care devices used in the hospital, and post hospital environments. It may be attached by flexible tubing to devices e.g. resuscitation bags; hyperinflation bags, CPAP Masks or Circuits.

The Gio Digital Manometer is light, portable, accurate and can be operate by one hand, monitoring airway pressure during respiratory care. The digital display facilitates easy reading of the pressure value. The manometer displays pressure values on the front panel both digitally and on an analog bar scale. The Gio Digital Manometer also provides a function that display peak pressure when the right button is pressed and the P&H function is activated. The Gio Digital Manometers are available in four different pressure ranges. All four manometers utilize the same mechanism and only differ in their pressure detecting ranges.

Acceptance Criteria and Device Performance for Gio Digital Manometer

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "Test Report 101004 'Measurement accuracy test'" as evidence of accuracy, but the details of this test, including sample size, are not within this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The device is a digital pressure manometer, and its performance is likely assessed against calibrated measurement standards rather than expert-established ground truth in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Performance is likely measured against calibrated standards rather than requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is a measurement tool, not an interpretive diagnostic aid requiring human reader intervention or improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done to assess the accuracy of the algorithm/device. The document states that the "Accuracy is within ± 0.4 of reading." This performance was evaluated in a "Measurement accuracy test" (Test Report 101004).

7. Type of Ground Truth Used

The ground truth for the "Measurement accuracy test" would have been established using calibrated measurement standards or reference instruments known to be highly accurate in measuring airway pressure.

8. Sample Size for the Training Set

This information is not provided. The device functions based on physical principles (pressure transducer) and likely does not employ machine learning that would require a "training set" in the conventional sense. Its "training" would be in its engineering and calibration.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" with established ground truth in this context is not directly applicable. The device's fundamental accuracy is built into its design and calibration process, which would involve comparing its readings against highly accurate, calibrated reference pressure sources.

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