(49 days)
To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement.
Not Found
This section provides an analysis of the provided FDA 510(k) document for the Ambu Esophageal Intubation Detector (Bulb version and Syringe version).
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or provide a table of performance metrics. The FDA's 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than setting specific performance thresholds for a new device's efficacy.
The "Indications For Use" sections for both the Bulb and Syringe versions state: "To assist verification of placement of the endotracheal tube in the trachea. Device is to be used as an adjunct to assess tracheal intubation. Its purpose is not to eliminate clinical judgement." This indicates the device is intended as an aid, not a definitive diagnostic tool on its own.
Without a detailed clinical study report, it is impossible to extract specific performance data like sensitivity, specificity, accuracy, or any comparative metrics against a ground truth.
2. Sample Size and Data Provenance:
The provided 510(k) summary letter and indications for use do not contain information about any specific study (clinical or otherwise) that would include details on sample size, test set characteristics, or data provenance (e.g., country of origin, retrospective/prospective). The letter refers to the "510(k) premarket notification," which would contain these details, but this specific document is not included in the input.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide any information regarding the number of experts used to establish ground truth, their qualifications, or the context of a "test set."
4. Adjudication Method:
Given the lack of information regarding a specific study or test set, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. Therefore, there is no reported effect size regarding human reader improvement with or without AI assistance, as this device predates widespread AI applications in medical devices and is a physical, non-AI diagnostic aid.
6. Standalone Performance:
The concept of "standalone performance" typically refers to the algorithm-only performance of an AI-based device. Since the Ambu Esophageal Intubation Detector (Bulb and Syringe versions) is a physical, mechanical device and not software or AI-driven, the concept of standalone algorithmic performance is not applicable. Its performance is inherent in its physical and mechanical operation.
7. Type of Ground Truth Used:
Without information about a specific study, the type of ground truth used cannot be determined from this document. For a device like this, common ground truth methods in a clinical study would typically involve:
- Direct Visualization/Bronchoscopy: The gold standard for confirming endotracheal tube placement.
- Capnography: Measurement of exhaled carbon dioxide, highly accurate for tracheal intubation.
- Clinical Assessment: Auscultation, chest rise, and other physical signs.
8. Sample Size for the Training Set:
This document does not contain information about a training set. As a physical, non-AI device, the concept of a "training set" in the context of machine learning is not relevant. Development for such a device would involve engineering design, prototyping, and testing rather than data-driven training.
9. How Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of device.
Summary of Information Not Found in the Provided Document:
The provided FDA letter is a 510(k) clearance letter confirming substantial equivalence to a predicate device. It does not include the detailed technical and clinical study reports that would contain the specific information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the full 510(k) submission, which is not part of the provided text.
§ 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).