(211 days)
The device is intended for Oral intubation and drainage of the subglottic space for airway management.
Well Lead Endotracheal Tube with Evacuation Lumen-Oral (6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm) The Well Lead Endotracheal Tube with Evacuation Lumen is sterile; single-use devices supplied with a standard 15mm connector. It is made of Polyvinylchloride. In addition to the main lumen, the tube has a separate lumen which has a dorsal opening above the cuff. Access to the lumen is accomplished via a clear connecting tube with a capped Luer connector. The tube incorporates a Magill curve, a tip with Murphy Eye and a radiopaque line to assist in radiographic visualization.
The provided text describes a 510(k) submission for a medical device, the "Well Lead Endotracheal Tube with Evacuation Lumen," and its substantial equivalence to predicate devices. However, this submission does not contain the kind of detailed study information (like a comparative effectiveness study with human readers, specific performance metrics, ground truth establishment, or sample sizes for training/test sets) that would be relevant for an AI/ML powered device.
The study described is a non-clinical performance evaluation against established standards for endotracheal tubes. Therefore, I cannot fully complete the requested table and information, as much of it pertains to AI/ML device evaluations which are not present in this document.
Here's what can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Compliance with EN1782:1998 | Results fell within required limits of the standard |
| Compliance with ISO 5361-1:1999 | Results fell within required limits of the standard |
| Surface Finish Dimensions Testing (I.D, O.D, Overall Length) | Results fell within required limits of the standard |
| Connector Testing | Results fell within required limits of the standard |
| Cuff Herniation | Results fell within required limits of the standard |
| Cuff Resting Diameter | Results fell within required limits of the standard |
| Tube Inflation | Results fell within required limits of the standard |
| Radius of curvature | Results fell within required limits of the standard |
| Angle of bevel | Results fell within required limits of the standard |
| Security of the construction of the evacuation lumen | Results fell within required limits of the standard |
| Shaft of the evacuation lumen | Results fell within required limits of the standard |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This was a non-clinical performance test against engineering standards, not a study involving patient data or a "test set" in the AI/ML context. The submission doesn't specify the number of devices tested for each parameter.
- Data Provenance: Not applicable in the context of patient data. The non-clinical tests were conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of non-clinical device testing, which focuses on adherence to engineering standards.
4. Adjudication method for the test set
- Not applicable. There was no need for adjudication as the testing involved objective measurements against established standard limits.
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, a MRMC comparative effectiveness study was not done. This device is an endotracheal tube, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- The "ground truth" for this submission was the established engineering and performance specifications defined by the EN1782:1998 and ISO 5361-1:1999 standards for endotracheal tubes. The device's physical and functional characteristics were measured and compared against these predefined limits.
8. The sample size for the training set
- Not applicable. There is no AI/ML component, so no training set was used.
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML component, so no training set or its ground truth establishment is relevant.
Summary of the study that proves the device meets the acceptance criteria:
The study was a series of non-clinical performance tests conducted on the Well Lead Endotracheal Tube with Evacuation Lumen. These tests evaluated various physical and functional attributes of the device, such as surface finish, dimensions, connector integrity, cuff characteristics (herniation, resting diameter, inflation), tube curvature, bevel angle, and the security of the evacuation lumen construction.
The device was tested according to EN1782:1998 and ISO 5361-1:1999 standards. The results of all these tests reportedly fell within the required limits of the respective standards, thereby demonstrating the device's compliance and substantial equivalence to legally marketed predicate devices. This type of testing is standard for demonstrating the safety and performance of medical devices like endotracheal tubes, which are subject to specific material and functional requirements.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).