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The GAV General Anesthetic Vaporizer is a concentration-calibrated device intended to deliver specific anesthetic agents into the fresh gas supply of an anesthesia workstation or anesthesia gas machine. The volatile agents intended to be used with this device are: Isoflurane, Sevoflurane and Halothane.

The GAV – General Anaesthetic Vaporizer is designed for use in continuous flow techniques of general anesthesia. It has a finely graduation that occipis and temperatures. Safety features such as unteriged Over a wide range of ther see incorporated together with many convenience features intenoun, Nor-oplir and Reyou Fillor are meet persition. GAV vaporizers are agent specific and are clearly labelled and colour coded for additional safety.

The provided document is a 510(k) summary for the GAV – General Anaesthetic Vaporizer. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device (Tec 5 Continuous Flow Vaporizer) based on clinical and technical comparisons. However, it does not include detailed information regarding acceptance criteria, a specific study proving those criteria, or the methodology (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) typically associated with such studies for AI/ML-based devices.

The document primarily focuses on demonstrating equivalence to an existing device through comparison of features and performance characteristics, rather than establishing performance against specific, quantifiable acceptance criteria through an independent study as one might expect for a novel AI/ML medical device.

Therefore, many of the requested items cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be provided based on the input:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics with pass/fail thresholds in this summary. The document discusses "similar relevant performance according to expected clinical effect" and "similar specifications and properties (Accuracy, temperature range, flow range, pressures and output matches the set concentration and remains constant over a number of changing/changeable variables)." However, it doesn't provide specific numerical acceptance criteria.
• Reported Device Performance: The document states that the device's output "matches the set concentration and remains constant over a number of changing/changeable variables." This is a qualitative statement of performance, but specific numerical performance results (e.g., ±X% accuracy) are not provided in this summary. It mentions "non-clinical tests the results of which are detailed in Section 4," but Section 4 itself is not provided in the input.

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

• Not provided. This document is for a mechanical vaporizer, not a data-driven AI/ML device. Therefore, a "test set" in the context of data for AI/ML is not applicable here.

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)

• Not applicable/Not provided. As above, this is not an AI/ML device, and no ground truth establishment through expert review of data is described. The equivalency claim is based on engineering design, materials, and expected functional performance likened to the predicate device.

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

• Not applicable/Not provided.

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

• Not applicable/Not provided. This is a mechanical vaporizer, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable/Not provided. This is a mechanical device, not an algorithm.

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

• Not applicable/Not provided in the traditional sense. The "ground truth" for a mechanical device like this would typically be established through engineering specifications, reference standards, and performance testing against those standards (e.g., flow meters, gas analyzers, temperature sensors). This summary does not detail the specific ground truth methodologies for the non-clinical tests it references.

8. The sample size for the training set

• Not applicable/Not provided. This is a mechanical device, not an AI/ML device that uses a training set.

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

• Not applicable/Not provided.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a medical device that is a mechanical anesthesia vaporizer. It does not contain the type of AI/ML-specific study information requested. The "proof" of the device meeting its intended function relies on non-clinical tests (results not detailed here) and a comparison to a legally marketed predicate device with similar design, materials, and clinical/technical performance characteristics.

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