Search Results

The indications for use for the Gas Module SE 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.

The subject device is a modified version of the Datascope Gas Module II, which was previously cleared by FDA under K974903 on March 13, 1998 and now marketed as the Gas Module SE. There have been no significant changes to the Gas Module SE since its clearance. At this time, Datascope Corp. has added a new feature to the Gas Module SE capabilities, the measurement of spirometry via a spirometry module, which is the same spirometry module residing in the Datex-Ohmeda Compact Airway Module M-CAIOVX and M-COVX (K001814).

The Gas Module SE is an independently powered unit capable of interfacing with Datascope Patient Monitors using the Datascope proprietary communications protocol.

The modified Gas Module SE measures in real-time, breath-by-breath O2, CO2, N2O gases. Additionally, the Gas Module SE monitors the anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane.

The Gas Module SE is composed of a spirometry module, a power supply and a communications interface board that enables the unit to communicate utilizing Datascope's proprietary communications protocol.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gas Module SE device:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the device's performance is asserted through a comparative study with predicate devices, rather than explicit numerical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

The document states "The results of verification tests conducted demonstrate that the functionality and performance characteristics of the Gas Module SE are comparable to the currently marketed predicate devices." However, it does not specify any sample size for the test set.

• Data Provenance: The document does not provide information regarding the country of origin of the data or whether it was retrospective or prospective. It only refers to "verification tests."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide any information about the number of experts used or their qualifications for establishing ground truth. The evaluation seems to be based on engineering verification tests against predicate devices rather than human expert interpretation or independent ground truth.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method. Given the nature of the device (gas module measurements), it's highly unlikely that an adjudication method like 2+1 or 3+1 would apply, as these are typically used for subjective assessments. The evaluation appears to be based on objective measurement comparisons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported. The device is a measurement device for gases and spirometry, not an interpretive AI system that assists human readers with diagnostic tasks. Therefore, the concept of improving human reader performance with AI assistance is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, the testing described appears to be a standalone performance evaluation of the device's functionality and measurement capabilities against predicate devices. The "verification tests" would assess the device's ability to accurately measure gases and spirometry without human intervention or interpretation of its outputs.

7. The Type of Ground Truth Used:

The ground truth for this device's evaluation is implicitly based on the accuracy and performance of the predicate devices. The new device's measurements and functionalities are compared against these established medical devices. There's no mention of pathology, expert consensus, or outcomes data being used as ground truth for this type of device.

8. The Sample Size for the Training Set:

The document does not mention a training set or any form of machine learning/AI development. This device is described as a "modified version" of a previously cleared device with an added spirometry module, rather than a novel AI system requiring training data.

9. How the Ground Truth for the Training Set Was Established:

Since there is no mention of a training set, the method for establishing its ground truth is not applicable and not provided.

Ask a specific question about this device