(250 days)
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:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Calibration Accuracy: Must be equivalent to the predicate device (PHYSIO-DYNE Easi-Lab Gas Analyzer). | "the data shows that the calibration accuracy of the Vacumetrics Gold Edition Oxygen Gas Analyzer is equivalent to the accuracy of the PHYSIO-DYNE Easi-Lab Gas Analyzer." |
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.
§ 868.1720 Oxygen gas analyzer.
(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).