(77 days)
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.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).