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510(k) Data Aggregation
(191 days)
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation SpO2, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
The Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations). Pulse oximetry may also be included as an option.
The provided document is a 510(k) summary for the Vamos Anesthetic Gas Monitor. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, a dedicated study proving performance against those criteria, or the methodology of such a study (sample sizes, ground truth establishment, expert qualifications, etc.).
Therefore, I cannot fully complete the requested table and answer all questions based solely on the provided text. The document refers to "Qualification of the Vamos included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing," which implies testing was done, but the specifics of acceptance criteria and results are not detailed.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General Device Performance | (Not specified in document) | Functionally equivalent to predicate devices (Vitalert 3000 and NPB4000 Pulse Oximeter) in multi-gas analysis (CO2, N2O, anesthetic agents) and pulse oximetry. Uses infrared absorption technology for gas analysis. |
| Specific Performance Metrics (e.g., accuracy, precision) | (Not specified in document) | (Not specified in document) |
| Functional Testing | (Not specified in document) | "Functional... testing" was performed. Specific results not reported. |
| Hazard Analysis | (Not specified in document) | "Hazard analysis" was performed. Specific results not reported. |
| Communication Testing | (Not specified in document) | "Communication... testing" was performed. Specific results not reported. Includes RS-232 serial communication. |
| Environmental Testing | (Not specified in document) | "Environmental... testing" was performed. Specific results not reported. |
| Electromagnetic Compatibility Testing | (Not specified in document) | "Electromagnetic compatibility testing" was performed. Specific results not reported. |
| Battery Backup Performance (Optional Battery) | (Not specified in document, implied to provide at least 1 hour) | Provides a one-hour minimum power reserve time from full charge (for optional battery backup system). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document refers to "qualification" testing but does not detail the nature, source, or type of data used (e.g., retrospective, prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable or not provided. The document describes a medical device's technical qualification and substantial equivalence, not an AI or diagnostic algorithm requiring expert-established ground truth for performance evaluation in the clinical sense.
4. Adjudication method for the test set
- Not applicable or not provided. This typically relates to diagnostic studies with human readers, which is not the primary focus of this 510(k) submission for a monitoring device.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed, as this device report is for a physiological monitoring device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the qualification testing described ("hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing") appears to be a standalone evaluation of the device's performance characteristics. However, the details of these tests and their specific results are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a gas monitor and pulse oximeter, the ground truth would typically be established using highly accurate reference methods or calibrated instruments for gas concentrations (e.g., mass spectrometry, certified gas mixtures) and oxygen saturation (e.g., co-oximetry, arterial blood gas analysis from a laboratory). The document does not explicitly state the specific ground truth methods used during its qualification testing.
8. The sample size for the training set
- Not applicable. This device is a hardware monitoring system, not an AI/ML algorithm that requires a "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this traditional medical device.
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