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The NM-MRI is a continuous flow anesthesia system. The NM-MRI may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. The NM-MRI is indicated for use with the Dräger Vapor® 19.1. The NM- MRI may be used in MRI scanner rooms with magnets up to 1.5 tesla, and with magnets over 1.5 tesla when installed using the NM-MRI High field Mounting Kit. Federal law restricts this device to sale by, or on the order of, a physician.

The NM-MRI is a continuous flow gas anesthesia system. The NM-MRI utilizes non ferromagnetic materials for structural elements and certain components have been shielded and/or relocated. The monitoring system of the NM-MRI differs from the NM GS by using a specially adapted version of the Core-M Omicron Monitor.

The provided text describes the Narkomed MRI Anesthesia System (NM-MRI), its intended use, and its substantial equivalence to the Narkomed GS (NM GS). However, it does not contain a table of acceptance criteria or a detailed study that explicitly proves the device meets specific acceptance criteria in a quantitative manner as would be expected for an AI/ML medical device.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive performance data against predefined acceptance criteria for a new clinical efficacy study.

Therefore, I cannot fulfill all parts of your request with the provided input. I will extract the information that is present and indicate where information is missing.

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

This information is not explicitly provided in the document in the format of a table with specific acceptance criteria and corresponding performance metrics for the NM-MRI. The document focuses on demonstrating substantial equivalence by stating that the NM-MRI has the "same intended use and principal of operation as the NM GS."

The closest the document comes to defining "acceptance criteria" is through the "qualification" activities mentioned:

• Hazard analysis
• System level qualification testing
• Environmental testing
• Electromagnetic compatibility testing
• Testing in an MRI environment

The "reported device performance" is described qualitatively by stating that the NM-MRI "has been qualified to meet environmental requirements for use in MRI facilities" and "utilizes non ferromagnetic materials for structural elements and certain components have been shielded and/or relocated." However, no quantitative performance metrics (e.g., specific thresholds for electromagnetic interference, vibration tolerance, or gas delivery accuracy) are provided, nor are the results of these tests presented in detail.

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

This information is not provided in the document. The document describes engineering and environmental qualification tasks rather than a clinical study with a "test set" in the context of patient data.

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)

This information is not provided in the document. As this is not a clinical study involving interpretation of patient data, the concept of "ground truth" established by experts for a test set is not applicable here.

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

This information is not provided in the document. Not applicable given the nature of the document.

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

This information is not provided in the document. The device is an anesthesia system, not an AI/ML-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

This information is not provided in the document. The device is an anesthesia system, not an algorithm.

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

This information is not provided in the document. The concept of "ground truth" in the context of clinical data for AI/ML devices is not applicable to an anesthesia machine's qualification. The "ground truth" for the engineering qualification would be adherence to specified engineering standards and performance specifications, but these are not detailed in the document.

8. The sample size for the training set

This information is not provided in the document. The device is not an AI/ML system that undergoes training.

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

This information is not provided in the document. Not applicable.

Summary of the available information from the document:

The provided document is a 510(k) premarket notification for the Narkomed MRI Anesthesia System (NM-MRI). Its primary purpose is to demonstrate substantial equivalence to previously cleared predicate devices (Narkomed GS Anesthesia System and Core-M Omicron Monitor).

• Acceptance Criteria/Performance Testing: The document states that "Qualification of the NM-MRI included a hazard analysis, system level qualification testing, environmental testing, electromagnetic compatibility testing, and testing in an MRI environment." It also notes that the device "has been qualified to meet environmental requirements for use in MRI facilities." Specific quantitative criteria or results are not detailed in this summary.
• Key Differences & Modifications: The NM-MRI uses non-ferromagnetic materials, certain components were shielded/relocated, and it uses a specially adapted version of the Core-M Omicron Monitor for its monitoring system.
• Intended Use & Equivalence: The NM-MRI has the "same intended use and principal of operation" as the predicate NM GS, with the added capability of being used in MRI environments (up to 1.5 tesla, and over 1.5 tesla with a special mounting kit).
• Nature of the Device: It is a continuous flow gas anesthesia system, not an AI/ML medical device, hence many of the requested criteria (test sets, training sets, ground truth from experts, MRMC studies) are not applicable to this type of submission.

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