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The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, alarming, and transferring of multiple physiological parameters including ECG (3-lead or 12-lead selectable, arrhythmia detection. ST segment analysis, oT analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), pulmonary artery wedge pressure (PAWP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation (Sv02/Scv02), carbon dioxide (C02), Oxygen (02), anesthetic gas (AG), impedance cardiograph (ICC), bispectral index (BIS), respiration mechanics (RM), and neuromuscular transmission monitoring (NMT). The equipment also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The arrhythmia detection, ST Segment analysis of Mortara algorithm, BIS, RM, CCO, SvO2/Scv02, PAWP monitoring and NMT monitoring are intended for adult and pediatric patients only;

• · ST Segment analysis of Mindray algorithm is intended for adult patients only:
• · C.O. monitoring is restricted to adult patients only;
  • ICG monitoring is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

The monitor is to be used in healthcare facilities by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

The subject Passport Series Patient Monitors includes two monitors:

• . Passport 12m Patient Monitor
• Passport 17m Patient Monitor ●

The Passport 12m and 17m Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.

The provided text describes a 510(k) premarket notification for the Passport Series Patient Monitors (Passport 12m and Passport 17m). The information mainly focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or a dedicated study proving performance against these criteria for the entire device.

However, the document does contain a "Device Comparison Table" that includes performance specifications for the Neuromuscular Transmission (NMT) module, which is a new feature for the subject device compared to the primary predicate, but present in a secondary predicate. This section implies a comparison of performance against the secondary predicate for the NMT module.

Based on the provided text, here's an attempt to extract the requested information, primarily focusing on the NMT module due to the lack of detailed performance study information for the overall patient monitor device:

1. Table of Acceptance Criteria and the Reported Device Performance

For the NMT module, the "acceptance criteria" can be inferred from the performance specifications of the secondary predicate device (Philips IntelliVue NMT module) and the "reported device performance" refers to the subject Mindray NMT module's specifications.

Study Proving Device Meets Acceptance Criteria:

The document states: "To establish the substantial equivalence of the Passport Series Patient Monitors (Passport 12m and Passport 17m), Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of the device relevant to each of the modifications to the subject devices since their previous clearance. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate."

For the NMT module specifically, the comparison table indicates that while some measurement intervals and the TOF-Ratio range differ, the underlying principles and most specifications are either "Same" or provide a "Wider TOF-Ratio Range" or "More Measurement intervals," implying that these variations are acceptable or represent an improvement.

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

The document does not provide details on the sample size used for the test set for performance validation for the NMT module or other parameters. It only mentions "functional and system level testing." The data provenance (country of origin, retrospective/prospective) is also 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)

This information is not provided in the document.

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

This information is not provided in the document.

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 document describes a patient monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

The document describes the performance of a medical device (patient monitor) and its modules, including the NMT module. The performance described in the comparison table are standalone specifications for the device's functionality. There is no explicit mention of an "algorithm only" study in the context of the device's overall operation, as it is a physical monitoring device. The NMT module's performance characteristics (e.g., current ranges, accuracies, measurement modes) are inherent to its design and function.

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

For the NMT module's performance specifications, the "ground truth" implicitly would be established through calibrated laboratory equipment and standard measurement techniques to verify the accuracy of stimulation outputs, ranges, and timing. For other physiological parameters, similar direct measurement against known standards would apply. The document does not explicitly state the methodology for establishing ground truth for any of the parameters.

8. The sample size for the training set

This is not applicable as the document describes a physical patient monitor with integrated measurement capabilities, not an AI/machine learning model that requires a "training set."

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

This is not applicable for the reasons stated above.

Summary of Limitations Based on Document:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Passport Series Patient Monitors to existing predicate devices, particularly regarding modifications and the addition of the NMT module. It provides a technical comparison of specifications rather than detailed clinical study data with explicit acceptance criteria and performance against those for all parameters. Information on sample sizes, data provenance, expert involvement for ground truth, and specific study methodologies (beyond "functional and system level testing") is not present in this document.

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