(166 days)
The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume.
The NMGS is a continuous flow gas anesthesia system.
The provided text is a summary of safety and effectiveness data for the Narkomed GS Anesthesia System (NMGS). It details the device's description, intended use, and claims of substantial equivalence to existing devices (Narkomed 2C and AV2+ Anesthesia Ventilator).
Crucially, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the quantitative sense typically expected for performance metrics. Instead, it focuses on demonstrating substantial equivalence to already approved devices.
Therefore, many of the requested categories cannot be filled as they relate to performance studies that are not described in this document.
Here's how to address your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria (based on substantial equivalence claim) | |
| Same intended use as Narkomed 2C and AV2+ | The NMGS has the same intended use as the Narkomed 2C and AV2+ Anesthesia Ventilator. |
| Same principle of operation as Narkomed 2C | The NMGS has the same principle of operation as the Narkomed 2C. |
| Integrated monitors for oxygen concentration, breathing pressure, and respiratory volume (like Narkomed 2C) | The NMGS, like the NM2C, is an anesthesia system with integrated monitors for oxygen concentration, breathing pressure, and respiratory volume. |
| Gas delivery system, absorber, and scavenger design same as Narkomed 2C | The gas delivery system, absorber and scavenger of the NMGS are the same design that is used on the NM2C. |
| Uses AV2+ anesthesia ventilator | The NMGS uses the AV2+ anesthesia ventilator, which is marketed as an integral subassembly of North American Dräger anesthesia systems. |
| Compatible with Vitalink serial link protocol for communication (like Narkomed 2C) | The NMGS, like the NM2C, is available with a serial interface for communication via the Vitalink serial link protocol to devices such as NAD's Vitalert 2000 and 3000 monitors. |
| Explicit Qualification Activities | |
| Hazard Analysis | Qualification of the NMGS included hazard analysis. |
| Software Verification | Qualification of the NMGS included software verification. |
| Qualification Testing | Qualification of the NMGS included qualification testing. |
| Environmental Testing | Qualification of the NMGS included environmental testing. |
| Electromagnetic Compatibility Testing | Qualification of the NMGS included electromagnetic compatibility testing. |
Explanation: The "acceptance criteria" here are largely implied by the concept of substantial equivalence, meaning the new device performs and functions similarly to the predicate devices. The "reported device performance" refers to statements in the document affirming these similarities or the completion of specific tests. Quantitative performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device) are not provided.
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 qualification activities, not a clinical performance study with a test set 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 applicable as the document does not describe a study involving expert-established ground truth for a test set in the traditional sense of a diagnostic or predictive device. The "qualification" of the device refers to engineering and safety testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an anesthesia system, 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
This concept is not applicable to this device. The Narkomed GS Anesthesia System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since the document describes engineering qualification and substantial equivalence, the "ground truth" would be related to engineering specifications, safety standards, and performance benchmarks derived from the predicate devices. For example:
- Engineering Specifications: Ensuring components meet design requirements.
- Safety Standards: Compliance with relevant electrical safety, biocompatibility, and anesthesia equipment standards.
- Predicate Device Performance: The functional and performance characteristics of the Narkomed 2C and AV2+ serve as the benchmark for substantial equivalence.
8. The sample size for the training set
This information is not provided and is not applicable to the type of device described. There is no "training set" in the context of an algorithm for this anesthesia system.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).