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The M1026B Anesthesia Gas Module is intended to measure and monitor anesthesia gas and to provide this data to health care contents in the volunation varially varialy via the Component Monitoring System, for the support of clinical decision making.

The device is indicated for use in health care facilities by health care professionals whenever The device is intriculour of assiric and neonate patient anesthesia gas monitoring.

The name of this device is the PhilipsM1026B Anesthetic Gas Monitor for use with the Philips IntelliVue Family of Patient Monitors MP40/50/60/70/90, the Anesthesia Component Monitoring System M1176A and the Philips Viridia 24 System. The common name is the Philips Anesthesia Gas Monitor.

This document is a 510(k) summary for the Philips M1026B Anesthetic Gas Monitor. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary identifies the device as being substantially equivalent to the Philips M1026A, which was cleared under K951127, K982619, and K994188. This means the manufacturer is asserting that the new device performs as safely and effectively as the predicate devices. The FDA's letter (APR 29 2004) confirms this determination of substantial equivalence.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This type of detailed performance data is typically found in the full 510(k) submission, not in the summary document. The summary focuses on substantiating equivalence, not on detailing a new performance study against specific acceptance criteria.

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The M1026A Anesthesia gas Module is intended to measure and monitor anesthesia gas contents in the ventilation circuitry of a patient and to provide this data to health care professionals in form readings, waves and alarms, via the Component Monitoring System, for the support of clinical decision making.

The device is indicated for use in health care facilities by health care professionals whenever there is a need for adult, pediatric and neonate patient anesthesia gas monitoring.

The above device operates with Agilent Technologies Anesthesia Component Monitoring System (ACMS) and the Viridia 24 Agilent Technologies Model 1204A through a digital interface (RS232). The monitoring system is known as the Model M1166A Component Monitoring System (CMS). When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients. The device will signal physiological alarms and document deviations when preset limits are exceeded. An INOP ("inoperative") alarm is triggered and a message is displayed in the event of malfunction, lack of detectable breath, power disconnects, and other inoperative states.

This 510(k) summary does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria, particularly for AI/Machine Learning devices. This document is for a medical device that measures physiological parameters. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text, indicating where information is not present:

Acceptance Criteria and Device Performance Study for Agilent Technologies M1026A Anesthetic Gas Monitor Option C05

This 510(k) submission describes the Agilent Technologies M1026A Anesthetic Gas Monitor Option C05, intended for measuring and displaying respiratory gases and anesthetic agents. The submission primarily focuses on demonstrating substantial equivalence to previously cleared devices (K951127 and K982619) rather than a de novo study against specific acceptance criteria for performance metrics like sensitivity, specificity, or agreement.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a table of acceptance criteria or specific performance metrics (e.g., accuracy, precision, bias) for the M1026A Anesthetic Gas Monitor. Such performance data would typically be found in test reports or validation studies, which are not part of this 510(k) summary. The submission asserts that the device operates with similar technological characteristics to its predicate device. It states concentrations are calculated by non-dispersive infrared analysis and O2 measurement by a paramagnetic transducer.

2. Sample size used for the test set and the data provenance

The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). Substantial equivalence claims for physiological monitoring devices typically rely on bench testing, comparison to predicate devices, and sometimes animal or human volunteer studies, but details are not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. This device is a measurement device for gas concentrations, not a diagnostic imaging or AI-based system requiring expert interpretation or ground truth establishment in the traditional sense for diagnostic accuracy studies. Ground truth for such devices is usually established through validated reference gas mixtures or laboratory equipment.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not applicable and not mentioned. This device is a gas monitor, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable in the context of this device. The device itself is a "standalone" monitor in that it measures and displays physiological data; it is not an algorithm that requires separate standalone performance testing in the way an AI diagnostic algorithm would. Its performance characteristics are inherent to its sensors and processing.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. For gas analyzers, ground truth would typically be established using:

• Certified reference gas mixtures (NIST-traceable): Precisely known concentrations of the target gases used for calibration and accuracy verification.
• Validated laboratory reference instruments: High-precision gas analyzers used to establish true concentration values.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physiological monitor based on established measurement principles (non-dispersive infrared analysis, paramagnetic transduction), not a machine learning or AI algorithm that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

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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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