(132 days)
The NM6000 w/ CV & SCR in indicated as a continuous flow anesthesia system. The NM6000 w/ CV & SCR may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, anesthetic agent identification and concentration and provides printed data. Federal law restricts this device to sale by or on the order of a physician.
The NM6000 Anesthesia Workstation has been modified to include optional Cardiovascular and Strip Chart Recorder Pods.
This document does not contain information about acceptance criteria or specific studies proving device performance in the manner requested (e.g., performance metrics, sample sizes, expert ground truth, statistical methods).
The provided text, identified as a "Summary of Safety and Effectiveness Data Relating to Substantial Equivalence" for the Narkomed 6000 Anesthesia System, focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.
Here's what the document does say regarding testing and comparison:
- Device Description: The NM6000 Anesthesia Workstation has been modified to include optional Cardiovascular (CV) and Strip Chart Recorder (SCR) Pods.
- Intended Use: Details the medical applications for the NM6000 with CV & SCR.
- Substantial Equivalence Claim: The document asserts that the "base functionality of the NM6000 product line remains essentially the same."
- Comparison to Predicate Devices:
- CV Pod: Uses a combination of Draeger Medical Inc. electronics and TRAM technology, both designed to monitor basic cardiovascular physiological parameters (ECG, temperature, invasive/non-invasive BP, cardiac output, pulse oximetry, ST segment analysis, synchronized cardioversion). It notes that the NM6000 CV pod differs from TRAM in that respiration, arrhythmia detection, and associated alarms will not be functional in the NM6000 CV pod.
- SCR Pod: Similar to the one in the Narkomed 4 Anesthesia System, differing only in communication type (standard parallel to parallel vs. serial to parallel).
- Qualification Activities: "Qualification of the NM6000 w/ CV & SCR included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing."
This type of submission (a 510(k) premarket notification) for a Class II device like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, functional testing, and demonstrating that any differences do not raise new questions of safety or effectiveness. It usually does not involve a clinical performance study with human readers or specific statistical acceptance criteria for diagnostic accuracy as might be found for an algorithm-based diagnostic device.
Therefore, I cannot fill out the requested table or provide information for most of the points because the provided text describes a regulatory submission for substantial equivalence, not a performance study as you've outlined.
To directly answer your numbered points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "Qualification of the NM6000 w/ CV & SCR included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing," implying these were generally met, but no specific criteria or performance metrics are detailed.
- Sample sized used for the test set and the data provenance: Not applicable/not provided. This was a qualification of a medical device, not a data-driven performance study on a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
- Adjudication method for the test set: Not applicable/not provided.
- 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. This is not an AI/algorithm-based diagnostic device or an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable. The "ground truth" for this device's qualification would be adherence to engineering specifications, safety standards, and functional requirements, rather than a clinical ground truth from patient data.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses a training set.
- How the ground truth for the training set was established: Not applicable.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).