Search Results

The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

The AS/3™ NMT Module is a part of the modular anesthesia monitoring system AS/3™. It provides relaxation measurement of patient. The NMT measurement hardware is in the NMT Module stimulates the Mores the patient controlled by the Net Compact Monitor central unit. The News NMT Module measures the respon responses from the NMT module, calculates the NMT values, displays the NMT values, handles NMT trending and NMT monitor features.

This 510(k) summary (K955000) for the Datex AS/3™ M-NMT Device is very brief and unfortunately does not contain the detailed information required to describe the acceptance criteria and the study proving device performance as requested.

The summary describes the device and its intended use but lacks any mention of performance metrics, clinical studies, or validation methods. It's a regulatory submission document primarily focused on demonstrating substantial equivalence to a predicate device, rather than a detailed technical or clinical trial report.

Therefore, I cannot fulfill your request with the provided input. To answer your questions, I would need a different type of document, such as:

• A clinical validation report
• A performance testing report
• A detailed risk analysis document that includes acceptance criteria for safety and efficacy
• A comprehensive summary of the 510(k) submission that includes performance data (which is not typically included in the publicly available 510(k) summary)

Without such detailed information, any attempt to answer the questions would be speculative and inaccurate.

Ask a specific question about this device