Search Results

The NM6400 w/IPM is indicated as a continuous flow anesthesia system. The NM6400 w/IPM 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 Narkomed 6400 w/ Integrated Patient Monitoring is a continuous flow gas anesthessa system with cardiovascular monitoring.

This document is a 510(k) premarket notification for a medical device called the "Narkomed 6400 w/ Integrated Patient Monitoring." It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/CADe (Computer-Aided Detection/Diagnosis) device, which is what the prompt's questions are tailored for.

The Narkomed 6400 is an anesthesia workstation, a physical device, not a software algorithm that provides diagnostics or interpretations. Therefore, the concepts of "test set," "ground truth," "expert consensus," "AI assistance," or "standalone algorithm performance" are not applicable in this context.

The "Qualification of the NM6400 w/ IPM" mentioned in the document states it "included a hazard analysis and system level qualification testing." This implies standard engineering and medical device testing for safety and functional performance, but it does not detail specific performance metrics against pre-defined acceptance criteria in the format requested.

Therefore, I cannot fill in the table or answer the specific questions about acceptance criteria and study design as no such information, relevant to AI/CADe devices, is present in the provided text.

The document mainly focuses on:

• Device Description: A continuous flow gas anesthesia system with cardiovascular monitoring.
• Intended Use: For spontaneous, manually assisted, or automatic ventilation during anesthesia, delivery of gases and anesthetic vapor, and monitoring of oxygen, breathing pressure, respiratory volume, CO2, N2O, cardiovascular parameters, and anesthetic agent identification and concentration.
• Substantial Equivalence: Claims equivalence to Narkomed 6000 w/ Cardiovascular and Strip Chart Recorder Pods (K993826), Marquette SL Series Transport Remote Acquisition (TRAM) (K921669), and Solar 7000/8000 System (K993757). The key difference highlighted is the addition of Wedge Pressure information via TRAM technology and cardiac trial calculations.
• Regulatory Information: 510(k) number (K033498), classification, and FDA's determination of substantial equivalence.

Ask a specific question about this device