(171 days)
To inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
The Easy Cuff™ is simple in-line pressures monitor which contains a calibrated diaphragm which distends with increases in cuff pressure. It is also capable of inflating or deflating the cuff.
Here's a breakdown of the acceptance criteria and study information for the Easy Cuff™ device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance (Easy Cuff™) |
|---|---|
| Accuracy | +/- 5% up to 30 cmH₂O |
| +/- 0.5 cm H₂O @ 10 cm H₂O | |
| +/- 1 cm H₂O @ 20 cm H₂O | |
| +/- 1.5 cm H₂O @ 30 cm H₂O | |
| Operating Temperature | Accuracy across different temperatures |
| Drop Test | Accuracy after drop test |
| Repeatability | Inter-sample and Intra-sample testing for repeatability across the pressure range |
Note: The document primarily outlines performance testing conducted rather than explicitly labeling each item as a "stated acceptance criteria" with a corresponding pass/fail value. The reported performance listed is extracted directly from the "Accuracy" and "Performance Testing" rows for the Easy Cuff™ in the comparison table with predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set (number of devices tested) for the accuracy, temperature, or drop tests.
It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing appears to be bench testing, which typically does not involve patient data provenance in the same way clinical studies do.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance testing described (accuracy, temperature, drop test) is bench testing, which usually relies on calibrated instruments and defined standards to establish ground truth, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers assess cases and discrepancies need resolution. Since the described testing is bench testing for device accuracy and durability, an adjudication method is not applicable and therefore not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes bench testing of the device itself, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device described, the Easy Cuff™, is a physical pressure monitor. It does not involve an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable. The performance testing described is for the standalone physical device.
7. The Type of Ground Truth Used
The ground truth for the performance testing (accuracy, temperature, drop test) would be established using calibrated reference standards and instruments. For example, a calibrated pressure sensor would be used to provide the "true" pressure against which the Easy Cuff's readings are compared.
8. The Sample Size for the Training Set
Not applicable. The Easy Cuff™ is a mechanical pressure monitoring device, not an AI or algorithm-based system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not AI/algorithm-based, there is no training set and therefore no ground truth establishment for a training set.
§ 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).