(15 days)
The Endotracheal Tubes are intended for airway management by nasal or oral intubation of the trachea. They are intended for use on Adult and Pediatric patients.
The Flexicare Endotracheal tube is a single lumen tube with or without a cuff. The device is used for airway management / gas transport and is connected to a ventilator or resuscitation devices via a connector and breathing tubing. Cuffed variants have an inflatable Cuff, a narrow inflation lumen and pilot balloon with valve permitting inflation and deflation using a suitable syringe fitted with a tapered luer connector. All variants (less reinforced) have a radio opaque marker consisting of an axial line embedded into the tube which enables identification the device when patient is x-ray viewed. All variants have a Murphy eye. All variants are supplied sterile and are single use/disposable.
The provided FDA 510(k) summary for the Flexicare Endotracheal Tube does not contain the kind of detailed information about acceptance criteria and study design that would typically be found in a submission for an AI/ML medical device. This document describes a traditional medical device (an endotracheal tube) and its substantial equivalence to a predicate device based primarily on meeting an international standard and having similar design and materials.
Therefore, for aspects related to AI/ML device evaluation, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, the answer will be that this information is not applicable or not provided in the given document because the device is not an AI/ML product.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meet ISO 5361: Anaesthetic and respiratory equipment - Tracheal tubes and connectors | The Flexicare Medical devices and predicate meet the requirements of the ISO standard. |
Study Details (for a Non-AI/ML Device)
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The summary indicates testing against ISO 5361, which is a performance standard for the physical characteristics and safety of tracheal tubes, not a clinical study requiring test sets of patient data. The standard covers aspects like dimensions, strength, cuff integrity, material biocompatibility, and sterilization. Actual "sample sizes" would refer to the number of tubes tested for these physical and material properties, but this specific detail is not given.
- The manufacturer is from the United Kingdom.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable / Not provided. For a traditional physical medical device like an endotracheal tube, "ground truth" as relevant to clinical data or expert interpretation is not established in the same way as for an AI/ML diagnostic device. The "truth" for this device resides in its adherence to engineering specifications and performance standards (like ISO 5361).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This concept is for resolving disagreements among multiple experts in clinical data labeling, which is not relevant here.
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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:
- Not applicable. This device is an endotracheal tube, not an AI/ML diagnostic or assistive device. No MRMC study was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm for this device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the typical sense for AI/ML. The "ground truth" for this device's safety and effectiveness is its compliance with the technical specifications and performance requirements outlined in the ISO 5361 standard. This involves objective measurements of physical properties, material analysis, and sterilization validation, rather than clinical outcomes or expert interpretation of patient data.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML product and does not have a training set.
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How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML product and does not have a training set or associated ground truth.
§ 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).