(49 days)
The Rüsch Easy Tube is a sterile single patient use, combination esophageal/tracheal tube intended to be used for emergency intubation, difficult intubation or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea.
The Rüsch Easy Tube consists of a 28 Fr (Small) or 41 Fr (Large), clear, twin lumen tube with a radiopaque stripe and graduated centimeter markings. The 28 Fr size is for use with patients 90 - 130 cm in height. The 41 Fr size is for use with patients over 130 cm in height. The device is designed to occlude the oro- and nasopharynx. The tube has a PVC high volume, low pressure, inflatable distal esophageal cuff and a larger proximal oropharyngeal cuff. Both cuffs are provided with self-sealing luer connector valves. A color-coded pilot balloon is provided for each of the color coding facilitates identification of the cuff/pilot balloon relationship. The clear pilot balloon corresponds with the clear distal cuff. The blue pilot balloon corresponds with the green proximal cuff. The shaft for the proximal cuff is also color-coded with a matching blue sleeve.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Rüsch Easy Tube, which is a medical device (tracheal tube). This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study or AI model.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is largely not applicable to this document.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the context of an AI/algorithm's performance. Instead, it compares the Rüsch Easy Tube to a predicate device (Kendall Combitube - K844746) based on design and performance characteristics to establish substantial equivalence.
| Comparison Point | Predicate Device (Kendall Combitube - K844746) | Rüsch Easy Tube (Reported Characteristics) |
|---|---|---|
| Intended Use | To be used for emergency, difficult or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea. | To be used for emergency, difficult or general anesthesia intubation. The device will provide sufficient ventilation whether the airway is placed into the esophagus or into the trachea. |
| I.D. Size | Small Adult - 37Fr, Regular - 41Fr | Small - 28Fr, Large - 41Fr |
| Cuff Style | High Volume, Low Pressure | High Volume, Low Pressure |
| Pilot Balloons - Color Coded | Yes | Yes (Clear Pilot Balloon for clear distal cuff, Blue Pilot Balloon for green proximal cuff) |
| Tube Available Separately | Yes | Yes |
| Graduations | No | Yes |
| Radiopaque Marker | No | Yes |
| Inflation Valve Type | Luer Activated | Luer Activated |
| Sterile | No | Yes (Sterile single patient use) |
Regarding the device meeting acceptance criteria: The document states, "All materials used in the fabrication of the Rüsch Easy Tube were evaluated through biological qualification safety tests as outlined in ISO 10993 Part 1 'Biological Evaluation of Medical Devices'. Comparative testing was performed. The materials used were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." This indicates that biological safety and material specifications were met according to established standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided because this is a 510(k) submission for a physical medical device, not an AI/algorithm-based diagnostic or treatment device that typically involves a "test set" in the sense of AI evaluation. The "comparative testing" mentioned refers to testing of materials and likely functional aspects against industry standards and the predicate device, not a data-driven test set.
3. 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. Ground truth as typically understood for AI models (e.g., expert consensus on medical images) is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. This device is a tracheal tube, not an AI-assisted diagnostic tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" implicitly refers to established material safety standards (ISO 10993 Part 1) and industry-recognized test methods for physical characteristics. For substantial equivalence, the "ground truth" is the performance and characteristics of the legally marketed predicate device (Kendall Combitube).
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).