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The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3 or 5 lead measurements
• Heart Rate derived from selected sources (ECG, SpO2, IBP)
• Pulse Oximetry (SpO2 )
• ST Segment Analysis derived from 3 or 5 lead measurements
• Arrhythmia Detection derived from 3 or 5 lead measurements
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) up to two (2) channels .
• Carbon Dioxide (CO2)
• Respiration Rate derived from ECG or CO2
• Temperature
• IV Drug Calculations

The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.

The Passport V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Passport V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Passport V may be powered by a rechargeable Lithium ion battery or through line-power. The Passport V may be equipped with optional infrared or predictive temperature and recorder modules, and may be mounted on an optional rolling stand for easy portability.

The provided 510(k) summary for the Passport V Monitor does not contain specific acceptance criteria or a dedicated study section with detailed performance metrics. It generally states:

"The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements."

This indicates that various performance tests were conducted to demonstrate compliance with relevant standards, but the summary does not explicitly list the acceptance criteria or the reported device performance in a table format.

Therefore, many of the requested details cannot be extracted from the given text.

Here's a breakdown of what can be inferred or stated as not available based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document refers to compliance with "recognized safety, performance and electromagnetic compatibility standards" and "appropriate test requirements" for software verification and validation, but specific numerical or qualitative criteria for each parameter (e.g., accuracy for heart rate, SpO2) are not provided.
• Reported Device Performance: Not explicitly stated in the document. The document confirms that the device was tested and found to be in compliance, but it does not present the results of those tests (e.g., measured accuracy, bias, or precision of physiological parameters).

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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:

• This device is a patient monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or expected for this type of device and is not mentioned.

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

• The Passport V monitor is a standalone device with algorithms for various physiological measurements (ECG, SpO2, NIBP, etc.). The statement "The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" implies that its standalone performance was evaluated against these standards. However, specific details of these standalone performance tests (e.g., how accuracy of Heart Rate was measured without human intervention) are not provided.

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

• For a patient monitor, ground truth would typically involve reference measurement devices (e.g., a calibrated ECG simulator for heart rate accuracy, a reference oximeter for SpO2, a calibrated pressure transducer for blood pressure). The document does not specify the exact methods or reference standards used to establish ground truth for its performance tests.

8. The sample size for the training set:

• This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense (i.e., for an AI model learning from data). It is a traditional patient monitor. Therefore, this information is not applicable and not provided.

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

• As a traditional patient monitor, the concept of a "training set" and its associated ground truth establishment is not applicable.

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