(32 days)
To assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube.
A device that relies on anatomical differences between the trachea and the esophagus. By applying negative pressure to the endotracheal tube, the rigid trachea remains open allowing free aspiration of air into the EDD, whereas the fibromuscular esophagus collapses around the endotracheal tube and thus prevents aspiration of air.
The provided text describes a 510(k) Summary for an Esophageal Intubation Device (EID). This document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving device performance against specific, pre-defined acceptance criteria with a rigorous study design. Therefore, the information provided does not fully align with the typical structure of an acceptance criteria and study report for novel device approval.
However, based on the information provided, we can infer and construct the closest possible response to your request:
1. Table of Acceptance Criteria and Reported Device Performance
It's important to note that the document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the new device. Instead, it relies on demonstrating that the EID performs comparably to the predicate device in its ability to detect the placement of a double lumen airway tube.
| Acceptance Criteria (Inferred from Study Conclusion) | Reported Device Performance (from Wafai et al. study) |
|---|---|
| Ability to correctly identify the location of the distal lumen (tracheal vs. esophageal) of an esophageal/tracheal double lumen airway tube. | Correctly identified the location of the distal lumen 100% of the time. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the Wafai et al. study's patient population where the EID was evaluated.
- Sample Size: 58 patients (20 tracheas, 38 esophagi).
- Data Provenance: The study by Wafai et al. took place in patients undergoing elective surgery. The country of origin is not specified, but the journal name "Anesthesiology" suggests an international or US-based context. The study is described retrospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth. The study design implies direct observation or verification of tube placement (e.g., surgical observation of where the tube was placed) rather than expert consensus on imaging. The phrase "The Combitube... was placed into 20 tracheas and 38 esophagi of patients" suggests the placement itself was the ground truth.
4. Adjudication Method for the Test Set
Not applicable. The study involved a direct determination of tube placement and the EID's output. There's no mention of an adjudication process for the EID's readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The provided text describes a study where the device (EID) was used by clinicians to make a determination, but it does not compare human readers with and without AI assistance to measure an effect size. The study is a direct performance evaluation of the EID.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the EID itself is a standalone physical device that provides an output (air return or no air return). The "algorithm" here is the physical principle of the device detecting negative pressure in the trachea vs. esophageal collapse. The study evaluates this standalone device's performance.
7. The Type of Ground Truth Used
The ground truth was established by direct observation/placement of the esophageal/tracheal double lumen airway tube in either the trachea or esophagus during elective surgery. This can be considered a form of clinical observation/procedure-based ground truth, as the actual anatomical placement was known.
8. The Sample Size for the Training Set
Not applicable. This device is a physical diagnostic tool based on anatomical principles, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a machine learning model.
§ 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).