(48 days)
The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. At is an adjunct to clinical assessment when verifying correct ET tube placement and respiration.
A non-sterile, single use, colorimetric carbon dioxide indicator with integral luer-lock connector, for placement in a gas sampling ported component, located between a tracheal tube and the breathing circuit, to detect exhaled CO2.
Pressure in the breathing circuit causes a low flow of breathing gas to pass into and through the indicator and vent to the atmosphere. The colorimetric media in the center window of the device indicates the presence of carbon dioxide in exhaled breath on a breath-by-breath basis.
The colorimetric media in the center window is blue when no carbon dioxide is present, green at intermediate concentrations and yellow when approximately 5% carbon dioxide is present. A breath-by-breath color change reflects ventilation of the patient. A permanent blue or blue-green color indicates absence of exhaled carbon dioxide. A damaged indicator will exhibit a permanent yellow or white color.
The indicator has a color scale against which the actual color may be compared to provide an approximate carbon dioxide concentration. Normal breathing gases, anesthetic gases, or water vapor do not affect the indicator.
The provided text describes a 510(k) premarket notification for a medical device called "C-CO2™ Colorimetric Carbon Dioxide Indicator." However, it does not contain details about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a detailed validation section of a 510(k) submission.
This document is primarily a summary of safety and effectiveness, an official FDA clearance letter, and the indications for use. It mentions performance characteristics in the device description (e.g., color changes indicating CO2 concentration), but it does not present quantifiable acceptance criteria or the results of a study designed to test against such criteria.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or multi-reader studies based on the provided text.
Here's what I can extract from the provided text based on your request, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantifiable thresholds (e.g., "sensitivity must be >X%"). The device description generally describes expected color changes.
- Reported Device Performance:
- Qualitative Description: "The colorimetric media in the center window is blue when no carbon dioxide is present, green at intermediate concentrations and yellow when approximately 5% carbon dioxide is present."
- Functionality: "A breath-by-breath color change reflects ventilation of the patient. A permanent blue or blue-green color indicates absence of exhaled carbon dioxide. A damaged indicator will exhibit a permanent yellow or white color."
- Interference: "Normal breathing gases, anesthetic gases, or water vapor do not affect the indicator."
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The device's operation is based on a chemical reaction indicating CO2, not on expert interpretation of complex data.
4. Adjudication method for the test set:
- Not mentioned.
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 done. This device is a simple colorimetric indicator, not an AI-powered diagnostic system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not mentioned. The device itself is the "standalone" indicator, but no performance study in the context of an "algorithm" is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Implicitly, the ground truth would be precise measurements of CO2 concentration (e.g., using a reference capnograph) and observation of the C-CO2 device's color change. This is not explicitly detailed as "ground truth" in the provided text.
8. The sample size for the training set:
- Not applicable/Not mentioned. This is a chemical indicator, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned.
In summary: The provided document is insufficient to answer most of your detailed questions regarding acceptance criteria and performance studies. It is a regulatory clearance document that primarily focuses on the device description, indications for use, and substantial equivalence to a predicate device, rather than providing the detailed technical validation data.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).