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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.

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The AS/3TM COPSv module is intended to be used in the Datex AS/3TM Anaesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, in intensive care department etc.

The AS/3TM COPSv Module is a parts of the modular anesthesia monitoring system AS/3™. It provides cardiac output (C.O.), right ventricular ejection fraction (REF), mixed venous oxygen saturation (SvO2) and invasive measurement of patient.

The provided text is a 510(k) summary for a medical device (Datex AS/3™ Cardiac Output and SvO2 Module). It describes the device, its intended use, and its measurement techniques. However, it does not contain any information regarding acceptance criteria, study details, or performance metrics that would allow for the completion of the requested table and study description.

Therefore, I cannot provide the requested information based on the input text. The 510(k) summary primarily focuses on the description and equivalence to previously cleared devices, not on the detailed clinical validation studies and their results.

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The AS/31M Compact Airway Module M-CAiOV is intended to be used in the Datex AS/3TM Anesthesia Monitor or in the AS/3TM Compact Monitor in anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.

The AS/3TM Compact Airway Module M-CAiOV is a part of the modular anesthesia monitoring system AS/3TM. It measures carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2) and anesthetic agent concentration (AA) of respiratory gases. The Airway Module also identifies anesthetic agent (ID) and measures airway pressure and volume (pV).

The sampled gases are analyzed by an infrared photometer and a paramagnetic oxygen sensor. Respiratory rate is derived from the CO2 signal. The anesthetic agents (halothane, enflurane, isoflurane, desflurane and sevoflurane) are identified from the sampled gases with infrared technique. Airway gas flow is measured with the aid of a pneumotachometer type transducer and airway pressure is measured from the same adapter by means of a pressure transducer.

This document appears to be a 510(k) summary for a medical device, specifically an AS/3™ Compact Airway Module M-CAiOV. It describes the device, its intended use, and argues for its substantial equivalence to a previously approved device (Datex AS/3™ Airway Module G-AiOV).

However, the provided text does not contain the detailed information required to answer your specific questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

Missing Information:

1. A table of acceptance criteria and the reported device performance: The document states that "Both gas measurement and spirometry measurement accuracy's were verified with both Compact Airway Module M-CAiOV and Airway Module G-AiOV at the same time. The results showed that both performed within specifications and the results were substantially equivalent." However, it does not list what those "specifications" (acceptance criteria) are, nor does it provide specific reported performance values for parameters like accuracy, precision, bias, etc., for the M-CAiOV.
2. Sample size used for the test set and the data provenance: The document mentions "results showed that both performed," implying a test was conducted, but provides no details about the sample size (e.g., number of measurements, number of patients, duration of testing), nor the origin or nature of the data (e.g., in-vitro, in-vivo, clinical trial, retrospective/prospective).
3. Number of experts used to establish the ground truth... and their qualifications: This device measures physiological parameters (gas concentrations, pressure, volume). The "ground truth" for these measurements would typically be established by highly accurate reference instruments or calibrated gas mixtures, not by human experts adjudicating images or clinical outcomes. The document does not describe how the reference standards were established.
4. Adjudication method for the test set: Not applicable, as it's a measurement device, not an interpretative one relying on expert review.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. MRMC studies are typically for image analysis or diagnostic interpretation devices where human readers are involved in diagnosis. This device provides quantitative measurements.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in terms of its measurement function. The "study" likely involved testing the device against known standards or another reference device.
7. The type of ground truth used: As mentioned above, for this type of device, ground truth would be established by highly accurate, calibrated reference instrumentation or certified gas mixtures. The document does not specify this.
8. The sample size for the training set: This device is not described as using machine learning or AI that would require a "training set" in the typical sense for diagnostic algorithms. It's an infrared photometer and paramagnetic oxygen sensor system.
9. How the ground truth for the training set was established: Not applicable, as there's no mention of a training set for an AI/ML algorithm.

Conclusion:

The provided text serves as a regulatory summary focusing on substantial equivalence, rather than a detailed technical report or study publication. While it asserts that "accuracy's were verified" and "results were substantially equivalent," it lacks the specific quantitative data, methodology details, and specific acceptance criteria needed to complete your request.

To answer your questions fully, you would need access to the actual verification and validation reports or the detailed specifications documents referenced in the 510(k) submission.

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