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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.

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The indications for use for the Passport 2™ include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3 or 5 lead measurements
• Heart Rate derived from selected sources (SpO2, ECG, IBP, NIBP)
• Blood Oxygenation (SpO2 )* measurement/waveform
• ST Segment Analysis
• . . Lethal Arrhythmia Detection
• Non Invasive Blood Pressure (NIBP) measurement
• . Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
• Respiration Rate/ waveform derived from ECG or CO2
• CO2 . Inspired and end tidal mainstream/waveform
• Temperature measurement via YSI 400/700 series probes
  The target populations are adult, pediatric and neonate with the exception of the Lethal Arrhythmia Detection and ST Segment Analysis for which the target populations are adult and pediatric only. The monitor is intended for use in the health care facility setting.
  The Passport 2 has the capability of interfacing with Datascope's Gas Module II, displaying the measurements of Anesthetic Gases, O3, N2O, and CO2.

• The Passport 2 monitors the SpO2 parameter via the Masimo SET® 2000 Pulse Oximeter Technology and Accessories (K990966). The Masimo SET® 2000 Pulse Oximeter Technology and Accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate (measured by an SpO2, sensor) and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities. mobile, and home environments.

Passport 2 is a transportable, multi-parameter physiological monitor designed to monitor ECG, Heart Rate derived from selected source (SpO2, ECG, IBP and NIBP), SpO2 level, ST Segment (adult and pediatric only), Arrhythmia (adult and pediatric only), Blood Pressure (both Invasive and Non-Invasive), Respiration Rate (derived from ECG or CO2), CO2 and Temperature, and for adult, pediatric, and neonatal patients who are under the care of a physician, within the confines of a health care facility.
The Passport 2 can display measurements of five Anesthetic Gases (Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane), O2, No O, and CO2 via connection to the stand alone Gas Module II ( K974903). The optional MediCO2 Microstream™ CO2 module (K964239), which uses the Oridion Microstream™ CO2 provides EtCO2, FiCO2 and Respiration Rate monitoring.
The optional built-in recorder provides hard copies of all digital data and waveforms as well as Tabular & Graphic Trend Information. Through its Comm Port the Passport 2 can communicate with the Visa Central Station (K913576), Gas Module II (K974903), Defibrillator (K930548), a Hospital's Nurse Call System or a Remote Color Display.

The provided 510(k) summary for the Datascope Passport 2™ Vital Signs Monitor describes its intended use and general performance testing, but it does not contain specific acceptance criteria tables nor detailed studies proving the device meets those criteria.

Instead, the document primarily:

• Identifies legally marketed predicate devices to establish substantial equivalence.
• States that the device has undergone "extensive safety and performance testing" to ensure it "meets all functional requirements and performance specifications" and complies with various industry standards (e.g., ANSI/AAMI EC13, IEC 60601-1 series).
• Mentions that certain components (NIBP system, SpO2 system, CO2 module, Gas Module II) are identical to or incorporate technology from previously cleared devices, making their performance substantially equivalent by reference.

Therefore, many of the requested details about specific acceptance criteria and the studies proving their achievement are not explicitly present in the provided text.

However, I can extract and infer information where possible based on the text provided.

Acceptance Criteria and Device Performance

The document does not provide a table of specific numerical acceptance criteria for each physiological parameter (e.g., accuracy range for NIBP, arrhythmia detection sensitivity/specificity) and the reported performance. It only states that the device was tested to "meet all functional requirements and performance specifications."

For example, for Non-Invasive Blood Pressure (NIBP), it notes:

• Acceptance Criteria (Implied): The NIBP measurement system used in the Passport 2 is the same as that used in Datascope's Accutorr Plus NIBP monitor (K983575). Therefore, the implied acceptance criteria would be those met by the Accutorr Plus, likely conforming to standards like ANSI/AAMI SP-10.
• Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Accutorr Plus NIBP monitor.

Similarly, for SpO2:

• Acceptance Criteria (Implied): The SpO2 measurement system is the same as that used in the Masimo SET 2000 Pulse Oximeter (K974903 and K990966). The implied acceptance criteria would be those met by the Masimo SET 2000, likely conforming to standards like ISO 80601-2-61.
• Reported Device Performance: Not explicitly stated for Passport 2, but stated to be "identical" to the Masimo SET 2000 Pulse Oximeter.

For other parameters (ECG, Arrhythmia, Respiration Rate, CO2, Temperature), the document states that the Passport 2 was tested to comply with relevant standards (e.g., ANSI/AAMI EC13 and EC 11, AAMI ECAR-1987, EN 864-1997, EN 865-1997, IEC 60601-2-27, IEC 60601-2-30). However, the specific performance values (e.g., error margins, sensitivity/specificity rates) are not quantified in this summary.

Detailed Study Information (Based on Available Text)

Since no specific studies are detailed within this 510(k) summary, the following points are based on what can be inferred or stated as not provided:

1. A table of acceptance criteria and the reported device performance:

   • Not provided in this summary. The document broadly states that the device "meets all functional requirements and performance specifications" and complies with various standards. For NIBP and SpO2, it refers to the performance of previously cleared devices whose technology is incorporated.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided in this summary. Details on specific test subjects (number, age, health status) or the nature of data (retrospective/prospective, origin) for any performance testing are absent. The primary testing mentioned is "safety and performance testing" which generally implies in-house verification and validation, possibly against simulators or human subjects for certain parameters, but details are missing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not provided in this summary. Ground truth establishment, if applicable to the device's functions (e.g., for arrhythmia detection comparison), is not discussed. For vital sign monitors, ground truth is typically established by reference devices or calibrated instruments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not provided in this summary. Adjudication methods are typically relevant for subjective assessments or expert consensus in interpretation tasks, which are not detailed here for a vital signs monitor.

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:

   • Not applicable/Not provided. This device is a vital signs monitor, not an AI-assisted diagnostic tool that involves "human readers" interpreting "cases" or "effect sizes of human improvement with AI." Its function is direct physiological measurement and display.

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

   • Yes, implied. The device itself is a standalone monitor that performs measurements (e.g., ECG, NIBP, SpO2) and algorithms (e.g., arrhythmia detection, ST segment analysis) without requiring human interpretation for its core function. Testing would focus on the accuracy and reliability of these algorithms against reference standards. The summary states "Final testing for the monitor included various performance tests designed to ensure that the device meets all functional requirements and performance specifications." This directly points to standalone performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Implied by device type. For vital signs monitors, ground truth is typically established using:
     • Reference standard instruments: For parameters like SpO2 (e.g., co-oximetry), NIBP (e.g., invasive arterial line measurement or a highly accurate reference NIBP device), Temperature (calibrated thermometer).
     • Standardized waveforms/inputs: For ECG feature detection (e.g., arrhythmia detection, ST segment analysis), validated databases of ECG signals or simulated signals with known characteristics may be used.
   • Explicit details are not in the summary.

8. The sample size for the training set:

   • Not applicable/Not provided. This document describes a traditional medical device, not a machine learning or AI-based system that uses a "training set" in the context of data-driven model development. The algorithms for vital sign processing in this device would have been developed through engineering principles, signal processing, and physiological modeling, not through training on large datasets in the modern AI sense.

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

   • Not applicable/Not provided. As stated above, there is no "training set" in the AI/ML sense described for this device.

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