(143 days)
The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.
The NF-009 Pressure Manometer is a low pressure gauge with a range of -20 to 80 cmH2O in marked increments of 1 cm H2O. The gauge has color coding green, yellow and red. The Manometer provides visual indication of airway pressure during ventilation or resuscitation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NF-009 Pressure Manometer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (NF-009) | Meets Criteria? |
|---|---|---|
| Accuracy: +/- 3 cmH2O for measurements 15 cmH2O | Within 1 cmH2O of Reference and Digital Gauge | Yes |
| Equivalence to test devices | Performs equivalently to test devices | Yes |
| Operates within the accuracy information specified for predicate devices (overall range) | Within 1 cmH2O of Reference and Digital Gauge (implying it meets/exceeds predicate) | Yes |
Note: The acceptance criteria are indirectly stated by referring to the accuracy of the predicate devices. The NF-009 significantly exceeds these criteria with a reported accuracy of within 1 cmH2O across its operational range.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "the comparison table" and implies testing across the operational range, but no specific number of measurements or devices tested is provided.
- Data Provenance: Not specified. It's an internal company test ("Performance Data"), but details on whether it's retrospective or prospective, or country of origin, are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts Used: Not applicable. The ground truth was established by a "Reference Gauge" and a "Digital Gauge," which are instruments, not human experts.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was based on instrument readings, not expert human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
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MRMC Study: No. This device is a manometer, a direct measurement tool. Its performance is assessed against reference instruments, not human interpretation in a multi-reader, multi-case study.
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Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: Yes, in essence. The "Performance Data" section describes the NF-009's accuracy when measured against other gauges. This is a standalone performance assessment of the device, independent of human interaction beyond operating the device and reading the values. It's not an algorithm, but a mechanical device.
7. The Type of Ground Truth Used
- Ground Truth Type: Instrumental/Reference Standard. The accuracy was determined by comparing the NF-009's readings to those of a "Reference Gauge" and a "Digital Gauge."
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is a mechanical manometer, not a machine learning algorithm, therefore there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set.
§ 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).