(116 days)
Endotracheal Tubes are indicated for use in providing airway management by oral intubation of the trachea during anesthesia and during ventilator support of respiration. Wire Reinforced Endotracheal Tubes are indicated for use in procedures requiring flexing of the neck or movement of the patient (lateral or prone position).
Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes are available in Cuffless or Air Cuff styles. All tubes consist of a radiopaque biocompatible wire reinforced silicone shaft and have a standard 15mm connector, depth marks in centimeters and two ring marks behind the cuff for reference in determining the position of the cuff or distal tip in the trachea.
Air Cuff Endotracheal Tubes have a radiopaque hooded tip to ease insertion through the vocal cords. Air Cuff Tubes also have an Above the Cuff Access Port (ACAP)® for removing secretions above the cuff to help prevent aspiration.
Air Cuff Endotracheal Tubes have an inflatable air cuff to seal the trachea. When properly inflated, the air cuff conforms to the shape of the trachea providing an effective seal. The tube has an inflation line with a luer valve and blue pilot balloon to indicate cuff inflation.
The provided 510(k) summary for K060094 describes a medical device, the Arcadia Medical® Silicone Wire Reinforced Endotracheal Tubes. It focuses on demonstrating substantial equivalence to pre-existing devices rather than outlining distinct acceptance criteria and a detailed study proving the device meets those criteria.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, as typically found in studies for AI/software devices, is not present in this document because this is not an AI/software device. This is a traditional medical device submission (endotracheal tube).
Here's an analysis based on the information provided, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a detailed performance table with numerical results as one would expect for a study evaluating an AI/software device. Instead, it states that "Performance Data for the device is shown in Section 11: Performance Standards" and "Performance Data indicates that the device is substantially equivalent in performance to the predicate device."
Without access to Section 11, specific criteria and performance values cannot be extracted. However, for traditional devices like endotracheal tubes, typical performance aspects relate to:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | The device utilizes a "radiopaque biocompatible wire reinforced silicone shaft." (Implied to meet relevant standards, though not explicitly stated as a pass/fail criterion here). |
| Functional Equivalence (e.g., tube dimensions, connector fit, cuff inflation mechanics, material properties, radiopacity) | "...substantially equivalent to the Predicate devices in all aspects," except for a unique molded tip and suction port on the Air Cuff Model. "When properly inflated, the air cuff conforms to the shape of the trachea providing an effective seal." (Implied to function comparably to predicates). |
| Safety and Effectiveness | Supports the conclusion that the device is "substantially equivalent in safety and effectiveness and in its intended use to existing legally marketed devices." |
| Intended Use Compatibility (airway management, ventilator support, use during neck flexing/patient movement) | The device's "Indications for Use" statement aligns with its design for oral intubation, ventilator support, and use where neck flexing/patient movement is required. |
2. Sample size 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. The document refers generally to "Performance Data" without detailing a specific test set, its size, or provenance. For a physical device, testing often involves bench testing (material properties, strength, leak rates), animal studies, or human cadaveric studies, but none of these specifics are mentioned.
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)
This is not applicable and not provided. The device is a physical endotracheal tube, not an AI/software requiring expert-established ground truth for a diagnostic task. Its performance is typically assessed through engineering tests and clinical equivalence to predicate devices, not through interpretation of outputs by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided. Adjudication methods are relevant for cases where multiple experts interpret data (e.g., medical images) to establish a consensus ground truth, which is not the context for this physical device submission.
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 and not provided. An MRMC study is relevant for evaluating the clinical utility and impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a physical medical device (an endotracheal tube), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable and not provided. This question pertains to AI algorithm performance evaluation, which is not relevant for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable and not provided in the sense of a reference standard for diagnostic accuracy. "Ground truth" for a physical device like an endotracheal tube would likely be defined by established engineering and medical standards for material properties, dimensions, integrity, and functional performance (e.g., cuff sealing pressure, flow rates, radiopacity). The document only generally refers to "Performance Standards."
8. The sample size for the training set
Not applicable and not provided. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable and not provided. As established in point 8, there is no training set for this physical device.
In summary:
This 510(k) submission for an endotracheal tube primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. The performance data mentioned (in Section 11, which is not provided here) would have focused on showing that the new device performs as safely and effectively as its predicates, likely through engineering bench tests, material characterization, and potentially pre-clinical (animal) or limited human use data, but not in the format of an AI/software performance study with distinct acceptance criteria, test sets, and reader studies.
§ 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).