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The Ohmeda Model 5330 Anesthetic Agent Monitor is intended for general hospital or clinical use by medical professionals whenever it is desired to monitor concentrations of anesthetic gas. The agents monitored include isoflurane, endoflurane, halothane, desflurane and sevoflurane. The need to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. It is available for sale only by or on the order of a licensed medical practitioner

The Ohmeda Model 5330 Anesthetic Agent Monitor is a benchtop instrument which draws a continuous flow of sample gas from a patient's anesthesia circuit. The sample is then drawn through a measurement chamber where agent concentration is measured. Measured values are displayed as numbers and as a graph on the illuminated display panel on the front of the unit is operated by push buttons on the front panel . The major functional subsystems of the device are the power supply, the pneumatic system, the measurement chamber, the electronics and the software. Power is supplied by a power cord connected to the AC line. There is no internal battery. AC power is conditioned internally by the power supply subassembly. The pneumatic system draws sample gas into the device through a moisture collection system. The sample then enters the measurement chamber, which is a cavity within the optical bench assembly. The sample is then exhausted out the back of the unit. The measurement cavity allows infrared light to be passed through the sample so a detector on the other side of the sample can measure the amount of absorption. The infrared light source consists of a coiled resistive metal element which radiates a relatively wide spectrum of infrared. Two infrared optical filters rotate on a wheel in the optical path, providing alternating wavelengths of illumination through the sample. The amount of transmitted infrared light is measured with an optical detector. By using the detected levels of transmitted infrared light at the two alternating wavelengths, anesthetic agent concentrations can be calculated. The electronic system consists of an analog circuit board and a digital circuit board . The analog board takes electrical signals from the measurement chamber and conditions them so measurement calculations can be performed. The digital circuit board digitizes the conditioned analog signals and performs measurement calculations. Proprietary software algorithms are used to calculate measured concentrations of anesthetic agent in the sample gas.

This submission describes the Ohmeda Model 5330 Anesthetic Agent Monitor, a device for measuring anesthetic gas concentrations.

Here's an analysis of the provided text in relation to acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics like accuracy, precision, or drift for the sevoflurane monitoring capability. Instead, it relies on the device's existing specifications and asserts that the new capability will not degrade them.

However, based on the narrative, the implicit acceptance criteria for the addition of sevoflurane monitoring are that:

• The existing measurement chamber is sufficient.
• No hardware changes are necessary.
• All specifications for existing features remain unaffected.
• The device appears physically identical to the current four-agent version (except for the sevoflurane option in the menu).

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

The document does not provide details on a specific test set, its sample size, or data provenance for validating the sevoflurane monitoring capability. It states that the device is commercially distributed outside the U.S., with emphasis in Europe and Japan, implying prior testing or usage in those regions, but no specifics are given here.

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

The document does not mention the use of experts or the establishment of ground truth by experts for a specific test set. The device measures gas concentration, which would typically be validated against a known gas standard, not expert consensus.

4. Adjudication Method for the Test Set:

Not applicable, as no external test set or expert adjudication is described in this summary.

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

No, an MRMC study is not applicable to this device. This is an anesthetic gas monitor, not an imaging device requiring human reader interpretation. The device's performance is objective measurement.

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

While not explicitly called a "standalone study," the core of the device's validation for sevoflurane relies on the statement: "The existing measurement chamber configuration is sufficient to accommodate the measurement method." and that "Proprietary software algorithms are used to calculate measured concentrations of anesthetic agent in the sample gas." This implies that the algorithm's performance is being assessed independently. However, the summary does not provide specific data from such a study directly demonstrating the accuracy or performance of the sevoflurane algorithm. It assumes sufficiency based on its existing design for other agents.

7. The Type of Ground Truth Used:

For a gas monitor, the ground truth would typically be known concentrations of sevoflurane gas delivered by a calibrated source. The document does not explicitly describe the "ground truth" method used for validating sevoflurane measurement. However, given the nature of the device, it would undoubtedly involve comparisons against precise gas mixtures.

8. The Sample Size for the Training Set:

The document does not provide information on a training set or its sample size. Proprietary software algorithms are mentioned, suggesting internal algorithm development and calibration, but no details are given.

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

The document does not describe how ground truth was established for any training set.

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