(250 days)
Intended for measuring the concentration of carrbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status.
Not Found
This response is based on the provided text, which is an SMDA Summary of Safety and Effectiveness Information for the Vacu•Med, Gold Edition, Carbon Dioxide Gas Analyzer (K973544).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of measurement of expired CO2 gases equivalent to the predicate device. | Calibration accuracy of the Vacumetrics Gold Edition Carbon Dioxide Gas Analyzer is equivalent to the accuracy of the PHYSIO-DYNE Easi-Lab Gas Analyzer. The device functions with an accuracy of 0.1% CO2. |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the sample size used for the comparative performance test. It only mentions "conditions of the test" and "the data." The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish a "ground truth" for the test set. The study focuses on comparing the new device's calibration accuracy against a predicate device.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as a specific "ground truth" was not established by multiple experts. The comparative test likely relied on a direct comparison of measurements between the two devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study was a direct comparison of a single device (the Vacu•Med Gold Edition) against a predicate device (PHYSIO-DYNE Easi-Lab Gas Analyzer) for calibration verification. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was conducted in the sense that the device's accuracy was tested directly against a predicate device for its intended function (measuring CO2 gases). This isn't an "algorithm only" in the modern AI sense, but rather a direct measurement of the device's functional output. The performance (accuracy of 0.1% CO2 and equivalence to the predicate) is reported for the device itself.
7. Type of Ground Truth Used
The "ground truth" for this study was the performance of a legally marketed predicate device (PHYSIO-DYNE Easi-Lab, K922660). The goal was to demonstrate substantial equivalence, meaning the new device performed as accurately as the established device.
8. Sample Size for the Training Set
No training set is mentioned. This device is a gas analyzer, and the study did not involve machine learning or AI that would typically require a training set. The evaluation was based on a direct comparative performance test.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
§ 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).