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The Passport Series Patient Monitors(Passport 12), are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, QT analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG).

All the parameters can be applied to single adult, pediatric and neonatal patients with the following:

• ·C.O. monitoring is restricted to adult patients only;
  · PAWP monitoring is not intended for neonatal patients;

· The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.

· 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitor only.

The monitors are to be used in healthcare facilities by clinical physiciate medical staff under the direction of physicians.

The subject Passport Series Patient Monitors includes two monitors:

• Passport 8 Patient Monitor ●
• Passport 12 Patient Monitor ●

All of the devices in the family are multiparameter monitors indicated for monitoring, displaying. reviewing, alarming, and transferring multiple physiological parameters. The Passport 8 and Passport 12 Patient monitors provide patient monitoring capabilities based on the user selected modules that are plugged into the main monitor.

This document is a 510(k) premarket notification for the Passport Series Patient Monitors (Passport 8 and Passport 12), not a study report. It states that "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."

Therefore, most of the information required to answer the question is not present in the provided text. The document refers to "Mindray conducted functional and system level testing" and "testing to ensure the subject devices meet relevant consensus standards" but does not detail the specific studies, sample sizes, or ground truth methodologies that would typically be found in a clinical study report.

However, based on the provided text, here is what can be inferred or explicitly stated regarding acceptance criteria and performance:

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

The document doesn't explicitly present a table of "acceptance criteria" alongside "reported device performance" like a typical study report. Instead, it compares the "Subject Devices" (Passport 8 and Passport 12) with a "Predicate Device (K132662)" and notes changes and additions in features. The "Performance Data" section broadly states that testing showed the devices "continue to meet specifications and the performance of the device is equivalent to the predicate."

For features where "Same" is indicated, the "Predicate Device" rows effectively represent the performance (specifications) that the current devices are expected to meet. For new or modified features, the stated capabilities in the "Subject Devices" row serve as the claimed performance.

Let's extract an example for a specific parameter based on the device comparison table:

• Added an additional Pace detection channel to enhance the Pace detection function
• Added ECG J-point auto detection
• Added adjustable QRS Detection Threshold |
  | Arrhythmia Analysis (Mindray Algorithm) | - Asystole, VFib/VTac, Vtac, Vent. Brady, Extreme Tachy, Extreme Brady, PVC, Couplet, Bigeminy, Trigeminy, R on T, VT>2, PVCs, Tachy, Brady, Missed Beats, Vent. Rhythm, PNP, PNC, Multif. PVC, Nonsus. Vtac, Pause, Irr. Rhythm | - Added AFib |

Crucially, the document does NOT provide quantitative performance metrics (e.g., sensitivity, specificity, accuracy, error margins) that would typically serve as acceptance criteria or reported performance figures from a clinical study for these algorithms. It only lists the features that the device supports and how they compare to the predicate.

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. The document states "Mindray conducted functional and system level testing," but no details about the sample size of the test set or the provenance of the data (e.g., patient demographics, country, retrospective/prospective nature) are given.

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. The document does not mention the use of experts for establishing ground truth for any testing performed.

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

• Not provided. No information regarding adjudication methods is mentioned.

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 patient monitor, not an AI-assisted diagnostic imaging device requiring human-in-the-loop comparison. The document focuses on the device's technical specifications and equivalence to predicate devices, not on improving human reader performance.

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

• Implied, but details are not provided. The document states that "Mindray conducted functional and system level testing on the subject devices." This implies standalone testing of the algorithms (e.g., for arrhythmia detection, ST segment analysis, QT analysis, NIBP accuracy) as part of ensuring they "meet specifications and the performance of the device is equivalent to the predicate." However, specific details of these standalone performance studies (metrics, methodologies) are not included.

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

• Not provided. The document doesn't specify how ground truth was established for the "functional and system level testing." For vital sign monitors, ground truth often involves comparison to established reference standards or expert-derived measurements.

8. The sample size for the training set

• Not applicable / Not provided. This document describes a medical device's premarket notification, not the development or validation of a machine learning algorithm where a distinct "training set" would typically be discussed. While the algorithms within the monitor (e.g., ECG algorithms) would have been developed and "trained," this document does not provide details of that process or associated training set sizes.

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

• Not applicable / Not provided. (See point 8).

In summary, the provided FDA 510(k) document is a regulatory submission for substantial equivalence, not a detailed scientific study report. It asserts that the device "meets specifications and the performance of the device is equivalent to the predicate" based on internal testing, but it does not provide the specific, granular data (sample sizes, expert qualifications, quantitative performance metrics, ground truth methodologies) that would be required to fully answer your questions about acceptance criteria and study particulars.

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Passport 12m and 17m Patient Monitors:

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), and respiration mechanics (RM). 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, and PAWP 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.

T1 Patient Monitor:

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, QT analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), pulmonary artery wedge pressure (PAWP), and carbon dioxide (CO2). 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 arthythmia detection, ST Segment analysis of Mortara algorithm, and PAWP monitoring are intended for adult and pediatric patients;

· ST Segment analysis of Mindray ECG algorithm is intended for adult patients only.

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 three monitors:

• Passport 12m Patient Monitor ●
• o Passport 17m Patient Monitor
• o T1 Patient Monitor

All of the devices in the family are multiparameter monitors indicated for monitoring, displaying, reviewing, alarming, and transferring multiple physiological parameters. 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 T1 patient monitor is one of the available modules that can be plugged into the Passport 17m or 12m monitor. The T1 can also be used as a standalone monitor and when used as a standalone monitor, it provides a subset of the functions that are provided by Passport 17m and 12m.

The provided text focuses on the substantial equivalence of the Passport Series Patient Monitors to predicate devices, rather than outlining specific acceptance criteria and a study demonstrating the device meets those criteria with detailed performance metrics. The information pertains to a 510(k) submission, which aims to show equivalence to a legally marketed device, not necessarily to prove it meets pre-defined acceptance criteria with a new, standalone study the way a PMA might.

However, I can extract information related to performance testing and changes from the provided text.

Here's an analysis based on the supplied document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds that the device must meet for specific clinical performance metrics. Instead, it describes "performance data" in the context of demonstrating substantial equivalence to a predicate device. The performance is assessed against the specifications of the predicate device and relevant consensus standards.

The table in the document (pages 7-8) compares the features and performance specifications of the subject devices to the predicate device (K143195). The relevant performance aspects are nested within the "Feature" column and include:

Note: For features like "QT analysis" (added to ECG Mindray Algorithm) and "AFib" (added to Arrhythmia Analysis Mindray Algorithm), and "Adjustable QRS Detection Threshold" (added), the document states "Added" or "Same" but does not provide specific performance metrics or acceptance criteria for these new or modified features in the provided text. It generally states that "The testing provided an evaluation of the performance of the device relevant to each of the modifications... 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."

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

The document states: "Mindray conducted functional and system level testing on the subject devices." It does not specify the sample size for this testing or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal engineering and verification testing rather than a clinical trial with patient data.

3. Number of Experts and Qualifications

The document makes no mention of experts being used to establish ground truth for a test set. The validation described is based on engineering and system-level testing against specifications derived from the predicate device and consensus standards.

4. Adjudication Method

No adjudication method is mentioned, as there is no indication of expert review or clinical ground truth establishment in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe a MRMC comparative effectiveness study, nor does it mention any effect size of human readers improving with or without AI assistance. This type of study would typically be conducted for diagnostic or interpretive algorithms, not necessarily for a multi-parameter patient monitor's basic physiological parameter measurements.

6. Standalone (Algorithm Only) Performance Study

The document generally refers to "functional and system level testing" and "conformance with applicable standards." While this implies algorithm performance was assessed as part of the overall device functionality, it does not specifically detail a standalone algorithm-only performance study with dedicated metrics like sensitivity, specificity, accuracy, etc., for a particular diagnostic output. The focus is on the device's ability to measure and present physiological parameters in a manner equivalent to the predicate.

7. Type of Ground Truth Used

Based on the provided text, the ground truth for the performance evaluations (e.g., accuracy of measurement ranges) would likely be established using calibrated test equipment, simulation, and potentially comparison to established reference methods or predicate device outputs during engineering and system-level testing. There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this submission. The "ground truth" for showing equivalence seems to be alignment with predicate device specifications and recognized consensus standards.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This is a 510(k) submission for a patient monitor, not a machine learning or AI-driven diagnostic device that would typically involve a separate training set. While the device does have "arrhythmia detection" and "ST segment analysis" algorithms, the document focuses on their functional equivalence and adherence to standards rather than detailing the methodology of their development or independent training/testing.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned, this information is not provided.

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