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The indications for use for the Gas Module II include monitoring of airway gases, during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.

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The provided text is a U.S. FDA 510(k) clearance letter for the "Datascope Corp. Patient Monitoring Division Gas Module II". This document confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

However, a 510(k) clearance letter does not typically contain detailed information about the acceptance criteria or the specific study that proves the device meets those criteria, nor does it include the methodology details requested in your prompt. These details are usually found in the 510(k) submission itself (which is not this document) or in supporting documentation provided by the manufacturer.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This statement is key – it indicates that the clearance is based on substantial equivalence, not necessarily on new studies proving acceptance criteria for novel performance claims.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, one would need access to the full 510(k) submission for K974903, which would contain the performance summary and supporting studies.

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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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