(45 days)
The device is intended for oral or nasal intubation. It is intended for airway management.
The Rusch Oral/Nasal Tracheal Tube, Plain, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black tip area is present on the tube to aid in visualization of the tube. An optional Murphy eye provides an alternative opening. The eye is the difference between the Murphy and the Magill Tube. The device is for Nasal/Oral use.
The provided text describes a 510(k) summary for the Rüsch Oral/Nasal Tracheal Tube, Plain-Magill/Murphy. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study designed to establish acceptance criteria for a new device's performance through clinical trials or extensive standalone evaluation.
Therefore, most of the information requested in your prompt cannot be directly extracted from this document, as it focuses on demonstrating safety and effectiveness by comparing the new device to a legally marketed predicate device based on technological characteristics and bench testing, rather than detailed performance metrics from a human study.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit from "Bench/Laboratory Testing"): The device conforms to ASTM 1242-89 for tracheal tubes and ISO 10993 for biocompatibility.
- Reported Device Performance: The document explicitly states "Based on test data, the device conforms to ASTM 1242-89. The device is biocompatible per the requirements of ISO 10993."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM 1242-89 | Conforms |
| Biocompatibility per ISO 10993 requirements | Biocompatible |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the bench testing.
- Data Provenance: Not specified. The testing is described as "Bench/Laboratory Testing," implying it was conducted in a controlled lab environment, likely by the manufacturer (Rüsch International, located in Jaffrey, NH, USA). The document does not specify if data was retrospective or prospective.
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. This document describes bench and biocompatibility testing for a medical device (tracheal tube). There is no "ground truth" in the clinical sense established by human experts for the performance metrics mentioned (conformance to ASTM standards, biocompatibility). These are evaluated against technical standards and laboratory protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods are typically used in clinical studies involving interpretation of medical data (e.g., imaging) by multiple readers to establish a consensus "ground truth." This document describes device manufacturing and material testing, not a clinical study requiring adjudicated interpretations.
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. This document does not describe an MRMC study or any study involving human readers, AI, or comparative effectiveness in a clinical setting. It's a regulatory submission for a physical medical device (tracheal tube), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument (tracheal tube), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Standards-based evaluation. The "ground truth" for the device's acceptable performance is defined by its conformance to ASTM 1242-89 (standard specification for tracheal tubes) and ISO 10993 (biological evaluation of medical devices). There is no clinical "ground truth" like pathology or outcomes data presented here.
8. The sample size for the training set:
- Not applicable. This document describes a physical medical device, not a machine learning model where a "training set" would be used.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or machine learning model is involved.
Summary of what the document does provide:
The document primarily focuses on demonstrating that the Rüsch Tracheal Tube is substantially equivalent to a predicate device (Sheridan Uncuffed Tracheal Tube Magill/Murphy Type) by:
- Describing its physical characteristics and intended use.
- Stating it is manufactured according to ASTM 1242-89.
- Reporting that bench testing confirms its conformance to ASTM 1242-89.
- Confirming its biocompatibility per ISO 10993.
- Highlighting its equivalence in design and intended use with the predicate product.
This type of submission relies on established technical standards and similarity to existing devices, rather than detailed clinical performance studies that would involve "ground truth" and expert reviews.
§ 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).