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The Narkomed M (NM M) is a continuos flow anesthesia system. The NM M may be used for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of oxygen, air, and/or nitrous oxide and anesthetic vapor. It is capable of monitoring oxygen concentration, breathing pressure, and respiratory volume. Federal law restricts this device to sale by or on the order of a physician.

The NM M is a continuous flow gas anesthesia system.

Here's a breakdown of the acceptance criteria and study information for the Narkomed M Anesthesia System, based on the provided text:

Acceptance Criteria and Device Performance (Implicit from Substantial Equivalence Claim):

The document doesn't explicitly list numerical acceptance criteria. Instead, it asserts substantial equivalence to a predicate device, the Narkomed GS (NMGS). Therefore, the "acceptance criteria" are implicitly met by demonstrating that the Narkomed M performs comparably to the Narkomed GS for its intended use, despite minor differences.

Study Information:

1. Sample size used for the test set and the data provenance:

   • The document describes a device qualification process, rather than a clinical study with human subjects or a defined "test set" in the context of AI/machine learning.
   • The testing involved a hazard analysis, system-level qualification testing, environmental testing, and electromagnetic compatibility testing. The sample size for these engineering tests would typically refer to the number of devices tested or the number of specific test conditions applied. This detail is not provided in the summary.
   • Data provenance: Not applicable in the sense of clinical patient data. The "data" comes from engineering and functional tests conducted presumably by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this is a device qualification for an anesthesia system, not a diagnostic device requiring expert interpretation of results for ground truth. Ground truth for these tests would be defined by engineering specifications and standards.

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

   • Not applicable. Adjudication methods are typically used in clinical studies or AI validation where inter-rater variability needs to be resolved to establish ground truth.

4. 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 MRMC study was done. This document is for an anesthesia system, specifically a 510(k) submission claiming substantial equivalence to a predicate device, not an AI-enabled diagnostic tool requiring an MRMC study.

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

   • Not applicable. This is not an algorithm-only device. It's a medical device with integrated monitoring and control functionalities, where the performance is inherently tied to its physical and software components.

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

   • The "ground truth" for the device's performance is based on engineering specifications, established medical device standards, and the performance characteristics of the predicate device (Narkomed GS). For example, during environmental testing, the ground truth would be that the device functions within specified parameters after exposure to certain conditions.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that relies on a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set mentioned or implied.

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