(141 days)
To measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
The CuffAlert™ is not intended to replacement clinical judgment.
The CuffAlert™ is a simple in-line pressure monitor which contains a calibrated diaphragm which distends with increases in cuff pressure.
One can set the maximum pressure limit from 10 to 40 cm H2O by rotating and locking a knob. Once set, it is placed on the pilot ballowing it to be in-line with the cuff. If the cuff exceeds the set pressure limit on the CuffAlert™ the diaphragm distends making contact with the battery, thus activating the red LED.
The accuracy of pressure measurement has been determined to be +/- 2 cm H2O @ 10 cm H2O; +/- 3 cm H2O @ 20 - 30 cm H2O; and +/- 4 cm H2O @ 40 cm H2O.
Here's a breakdown of the acceptance criteria and the study information for the CuffAlert™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Performance) | Reported Device Performance (CuffAlert™) |
|---|---|
| +/- 2 cm H₂O @ 10 cm H₂O | +/- 2 cm H₂O @ 10 cm H₂O |
| +/- 3 cm H₂O @ 20 - 30 cm H₂O | +/- 3 cm H₂O @ 20 - 30 cm H₂O |
| +/- 4 cm H₂O @ 40 cm H₂O | +/- 4 cm H₂O @ 40 cm H₂O |
Note: The document describes the "accuracy of pressure measurement has been determined to be" these values. This language implies these are both the acceptance criteria and the (successful) reported performance.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only states that the accuracy "has been determined."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for any testing of the device.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a physical pressure monitor, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
The device is a physical pressure monitor and does not utilize an algorithm in the way a diagnostic AI would. Therefore, a "standalone (algorithm only)" performance study, as typically understood for AI, is not applicable and not mentioned. The stated accuracy is for the device's inherent mechanical function.
7. Type of Ground Truth Used
The ground truth for the accuracy assessment of a pressure monitor would typically be established by comparison against a calibrated reference standard pressure measurement device. While the document doesn't explicitly state "calibrated reference standard," in the context of pressure measurement accuracy, this is the implied method for "determining" the accuracy.
8. Sample Size for the Training Set
The document does not specify a training set sample size. This type of device (a mechanical pressure monitor) would not typically involve a "training set" in the context of machine learning or AI. Its performance is based on its design and physical calibration.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of AI/ML, this information is not applicable to the CuffAlert™ device. Its ground truth (accuracy) would be established through physical calibration against known pressure standards.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).