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The Dräger Dräger Infinty MCable Mainstream CO2 sensor is meant to be used for continuous, real time measurement of CO2 concentrations of ventilated patients from neonates to adults. This sensor is only intended for use with devices made by Dräger Medical, or with devices which are approved for use with Dräger CO2 components (Dräger-compatible devices).

The Infinity MCable - Mainstream CO2 uses infrared absorption technology to accomplish mainstream CO2 measurements. The sensor is able to measure end-tidal CO2 and inspired CO2 and calculates the respiratory rate. This measurement module is integrated inside the sensor and no longer part of the host device (e.g. ventilator). CO2 compensation has been advanced for the foreign gases helium and nitrous oxide.

The provided text is a 510(k) summary for the Dräger Infinity MCable - Mainstream CO2, a device designed for continuous, real-time measurement of CO2 concentrations. The summary primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the detailed aspects of a clinical study typically associated with AI/ML device evaluations. Therefore, a table of acceptance criteria and reported device performance cannot be generated, nor can details about sample size, expert ground truth, adjudication methods, or MRMC studies be provided from this document.

The document states that "All modifications have been evaluated for safety and effectiveness. The summary of the design control activities and the risk analysis show that these types of modifications do not change the device operating principle or mechanism of action. The modifications do not alter the fundamental scientific technology and therefore the safety and effectiveness is substantially equivalent to the legally marketed predicate device." This indicates that the evaluation of the device relied on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance metrics described in this summary.

Information that can be extracted from the provided text:

While the detailed study information is not available, here's what can be inferred or directly stated from the document:

• Device: Dräger Infinity MCable - Mainstream CO2
• Purpose: Continuous, real-time measurement of CO2 concentrations in ventilated patients (neonates to adults).
• Technological Principle: Uses infrared absorption technology (specific dual wavelength infrared absorption by CO2 molecules).
• Measured Parameters: CO2 waveform, end-tidal CO2, inspired CO2, and respiration rate from capnogram.
• Measurement Range: 0 to 100 mmHg.
• Predicate Device:
  • K051263 - Evita XL, Option SmartCare with Option Capno Package CO2 Mainstream sensor #6871500 (Dräger Medical AG & Co. KG)
  • K042601 - CAPNOSTAT 5 (RESPIRONICS NOVAMETRIX, INC.)

The following details are not present in the provided 510(k) summary:

1. Table of acceptance criteria and reported device performance: Not included. The document focuses on substantial equivalence rather than explicit performance metrics against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 relevant or mentioned. This is a CO2 measurement sensor, not an AI/ML-driven diagnostic imaging device requiring human reader improvement studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not explicitly detailed, but as a sensor, its performance is inherently standalone in generating the measurements. There is no "human-in-the-loop" performance as described for AI/ML diagnostic tools.
7. The type of ground truth used: Not explicitly stated, as the evaluation was based on substantial equivalence to predicate devices and design control activities. For CO2 sensors, ground truth would typically come from calibrated gas mixtures or established reference methods.
8. The sample size for the training set: Not applicable and not mentioned, as this device primarily relies on a physical principle (infrared absorption) rather than a machine learning model trained on data.
9. How the ground truth for the training set was established: Not applicable and not mentioned.

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