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CapnoDura Pedi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 1 kg - 15 kg. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.

CapnoDura Combi: To provide a semi quantitative visualization of the CO2 in the patient airway. This device is to be used on patient weighing 10 kg or above. It is an adjunct in patient assessment to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician. To assist verification of tracheal tube placement in the trachea following intubation and to observe respiration by the detector's color changes.

The CapnoDura Combi & CapnoDura Pedi CO2 Detectors are non-sterile, single use, colorimetric CO2 detectors to be connected between a breathing circuit and a tracheal tube. The colorimetric indicator area in the center of the device indicates the presence of carbon dioxide during the breathing to assist verification of tracheal tube placement in trachea following intubation and to observe respiration by the detector's color changes The indicator panel is blue when no CO2 is present, green at intermediate concentrations and yellow when approximately 5% CO2 is present. A permanent blue or blue-green color indicates absence of exhaled CO2. A damaged indicator will exhibit a permanent yellow or white color.

The unit has a printed reference scale against which the actual indicator color may be compared to obtain an approximate CO2 concentration. There are two sizes of the detector, Combi and Pedi, and these will fit with the breathing circuit and tracheal tube connections for both adults and children, respectively. The connections are ISO standard dimensions

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "In vitro performance tests were performed," but does not specify the sample size for these tests. The provenance of the data is not explicitly stated, but it's implied to be from the manufacturer (Seebreath AB) as part of their verification testing. The tests are described as "in vitro," meaning they were conducted in a controlled laboratory environment rather than on live subjects (retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the in vitro performance tests. The tests performed are objective, physical measurements (e.g., dead space volume, flow resistance, color change) and would likely be assessed against predetermined engineering specifications rather than expert consensus.

4. Adjudication Method for the Test Set

Since experts were not involved in establishing ground truth for the performance tests, no adjudication method such as 2+1 or 3+1 was used or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document describes in vitro performance tests of the device itself and mentions material equivalence to predicate products. There is no indication of a multi-reader multi-case comparative effectiveness study involving human readers with or without AI assistance. The device is a colorimetric CO2 detector, not an AI-powered diagnostic tool requiring human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in essence. The performance tests described (dead space volume, flow resistance, color change, etc.) are evaluating the standalone physical and functional aspects of the device without human intervention or interpretation beyond observing the color change. The device's primary function is to chemically react to CO2 and display a color change, which is an inherent property being tested.

7. The Type of Ground Truth Used

The ground truth used for the performance tests appears to be engineering specifications and predetermined performance requirements for physical and functional parameters (e.g., specific dead space volume limits, specific flow resistance limits, expected color changes at certain CO2 concentrations, ISO standard dimensions for fittings).

8. The Sample Size for the Training Set

Not applicable. The device is a physical, colorimetric CO2 detector. It does not employ an algorithm or AI that requires a "training set" in the computational sense. The device's function is based on chemical reactions and physical design, not machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. As stated above, there is no training set for this type of device.

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