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The Vamos Anesthetic Gas monitor is indicated for measuring and monitoring CO2 concentration, functional oxygen saturation (SPO2), pulse rate and the concentrations of N2O, Halothane, Isoflurane, Enflurane and Desflurane.

The modified Vamos is an integrated monitoring system used for the multiple gas analysis (CO2), N2O), and anesthetic agent concentrations). Pulse Oximetry may also be included as an option.

This document is a 510(k) premarket notification for the Vamos Anesthetic Gas Monitor, which is a modified version of an existing device. The notification primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the ability to return sample gas to the breathing circuit. It is not a study report that describes acceptance criteria, device performance results, or a detailed study design.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them cannot be found in the provided text. The document is a regulatory submission for market clearance, not a scientific publication detailing a performance study against specific acceptance criteria.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that "Testing was performed to assure that there would be no adverse effects to the patient as a result of the sample gas passing through the Vamos and back to the breathing circuit instead of being routed to the scavenger." This is a qualitative statement about the purpose of testing, not a report of the test results themselves or the criteria used to deem them acceptable.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not detail any specific test set, its sample size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No information about ground truth establishment or experts is included.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be provided. No test set or adjudication method is described.

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

• Cannot be provided. This device is an anesthetic gas monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. This question is not applicable as the device is a monitor, not an algorithm, and the concept of "standalone performance" in the AI sense does not apply here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. No specific ground truth methodology is mentioned. The "testing" referred to appears to be engineering or bench testing related to the gas return mechanism, not a clinical study requiring ground truth for diagnostic accuracy.

8. The sample size for the training set

• Cannot be provided. This document describes a modification to an existing device, which doesn't typically involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Cannot be provided. See point 8.

In summary: The provided text is a regulatory submission for premarket clearance based on substantial equivalence, not a scientific or clinical study report. It focuses on the device's description, intended use, and its similarities to previously cleared devices, particularly highlighting a modification and confirming testing was done without adverse effects. It does not contain the detailed performance data, acceptance criteria, or study methodologies requested.

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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

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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