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Intended for measuring the concentration of carrbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status.

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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

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.

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The indications for use of the Gold Edition VacuMed Oxygen Gas Analyzer are to measure expired Oxygen Gases.

The Vacumetrics Gold Edition Oxygen Gas Analyzer is a device that incorporates a Vacu. Med designed oxygen gas analyzer housing, with a commercially available oxygen paramagnetic gas analyzer (Servomex 1155B), a commercially available power supply (Condor), and other commercially available components to include a commercially available digital meter display which does not utilize any software.

Here's a breakdown of the acceptance criteria and study information for the Vacu•Med, Gold Edition, Oxygen Gas Analyzer, 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 does not specify a numerical sample size for the test set. It mentions "A comparative performance test," but details like the number of tests conducted, the duration of tests, or the amount of data collected are not provided.

• Data Provenance: Not explicitly stated. The context implies the testing was conducted by the manufacturer, Vacumetrics Inc. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable. This device is an analyzer for a physical measurement (oxygen gas), not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for calibration accuracy would be a known, highly accurate reference standard for oxygen concentration.

4. Adjudication Method for the Test Set:

Not applicable, as expert consensus or adjudication is not relevant for calibrating a gas analyzer against a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not applicable to a device measuring oxygen gas concentration, as it does not involve human readers interpreting cases.

6. Standalone Performance Study:

Yes, a standalone performance test was done, focusing on "calibration verification" of the Vacu•Med Gold Edition Oxygen Gas Analyzer. The study compared its accuracy directly to the predicate device.

7. Type of Ground Truth Used:

The "ground truth" implicitly used for the test set was the performance/accuracy of the predicate device (PHYSIO-DYNE Easi-Lab Gas Analyzer). The study's objective was to demonstrate equivalence in calibration accuracy, meaning the predicate device served as the reference standard for "correct" performance.

8. Sample Size for the Training Set:

Not applicable. This device is a measurement instrument and would typically not involve a "training set" in the machine learning sense. Its functionality is based on established physical principles of gas analysis rather than an algorithm trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reasons as point 8.

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