(51 days)
The TaperGuard Evac™ Endotracheal tube is indicated for airway management by oral/nasal intubation of the trachea, and for evacuation or drainage of the subglottic space.
The TaperGuard™ Endotracheal tube is a device inserted into a patient's trachea via the nose or mouth to maintain an open airway.
The TaperGuard™ and the TaperGuard Evac™ Tracheal Tubes are sterile, single-use devices supplied with a standard 15mm connector. On the Evac tubes, in addition to the main lumen, the tube has a separate Evac 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 hooded tip with a Murphy Eye and a Tip-To-Tip™ radiopaque line to assist in radiographic visualization.
This document is a 510(k) summary for the TaperGuard™ Endotracheal Tubes and TaperGuard Evac™ Endotracheal Tubes. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics.
Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text. The document is primarily a regulatory submission outlining claims, device description, and comparison to predicates.
However, I can extract the available information and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (TaperGuard™ Endotracheal Tubes) |
|---|---|
| Reduce micro aspiration | Reduces micro aspiration by an average of 90% (in comparison to Hi-Lo Basic Barrel Shaped PVC Cuff Endotracheal tube). |
| Associated with a decrease in the rate of nosocomial pneumonia (VAP) in specific clinical circumstances (for TaperGuard Evac™). |
Note: The document does not explicitly state quantitative acceptance criteria (e.g., "micro aspiration reduction must be at least X%"). The reported performance is the claim being made.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified. The claims relate to "in comparison" with other devices and "in specific clinical circumstances," suggesting clinical data or preclinical studies, but details are not provided. It is not stated if it's retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- This device is an endotracheal tube, not an AI-powered diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Similar to point 5, this is a physical medical device. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the claim of "reducing micro aspiration," the ground truth would likely be established through quantitative measurement of micro aspiration in a model (e.g., in vitro, animal model, or clinical study with aspiration markers).
- For the claim of "decrease in the rate of nosocomial pneumonia (VAP)," the ground truth would be outcomes data (diagnosis of VAP) from clinical studies.
- Specific methodologies for establishing these ground truths are not detailed in this summary.
8. The sample size for the training set
- This is a physical medical device; the concept of a "training set" in the context of an algorithm is not applicable. Any "training" would refer to design iteration and testing.
9. How the ground truth for the training set was established
- As per point 8, the concept of a "training set" in this context is not applicable.
In summary:
This 510(k) Special Summary focuses on demonstrating substantial equivalence based on claims of improved performance (reduced micro aspiration) compared to predicate devices. It clearly states the performance claim (90% reduction in micro aspiration and association with decreased VAP). However, it does not provide the detailed study specifics (e.g., sample sizes, experimental design, ground truth establishment methods, expert involvement) that would typically be found in a detailed clinical or preclinical study report. This level of detail is usually part of the full 510(k) submission, not the publicly available summary.
§ 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).