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Passport 12m and 17m Patient Monitors:

The Passport 17m and Passport 12m patient monitors are intended for monitoring, displaying, reviewing, 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 (SvO2/ScvO2), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AC), impedance cardiograph (CCG), 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/ScvO2, 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.

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:

• o Passport 12m Patient Monitor
• 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.

This document is a 510(k) summary for the Mindray Passport Series Patient Monitors (Passport 12m, Passport 17m, and T1). It focuses on establishing substantial equivalence to previously cleared predicate devices and does not contain a full study report with detailed acceptance criteria and performance data for a new AI/ML device.

Therefore, the following information, relevant to AI/ML device studies, cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document states that "functional and system level testing" was conducted and that the devices "continue to meet specifications and the performance of the device is equivalent to the predicate." However, it does not provide specific acceptance criteria values or detailed performance metrics.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 relevant as this is not a new AI/ML device being submitted for comparative effectiveness.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant as this is not a new AI/ML device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Summary of available relevant information from the document:

This 510(k) submission is for modifications to existing patient monitors, not for a new AI/ML device. The changes include:

• Wireless Module: Addition of a Laird (2.4GHz/5GHz) wireless module.
• MPM Module: Addition of an MPM 3.0 module with similar functionality to the MPM 2.0 module.
• Masimo SpO2 accessories: Support for new Masimo SpO2 accessories.
• ECG accessories: Support for new ECG accessories (12-lead, defibrillation-proof).
• CO2 accessories: Support for new DRYLINE PRIME and DRYLINE PRIME+ gas sampling lines and water traps.
• Signal Cord Resistance: Improvements to SpO2/CO2/BIS signal cord resistance to damage.
• NIBP Issue Correction: Correction of an issue where NIBP misreported "NIBP Excessive Motion" after 49 days.
• Anesthetic Agent (AA) Numerics: Support for End tidal (Et) and Fraction of Inspired (Fi) numerics for anesthetic agent (AA).
• Physiological Alarms: Support for specific physiological alarm behaviors (triggered only when parameter value is higher/lower than limits, re-alarming after reset, non-overlapping relationships of alarm limit setting).
• Alarm Setup Menu: Support for password protection for accessing the Alarm Setup menu.
• User Authorization: Support for user authorization via LDAP.
• Patient Monitor Information: Support for Facility information, Room No. information, and Visit Number in patient demographics.
• Printing: Support for printing arrhythmia settings in reports, changing factory default printer paper size, and QT report printing.
• MAC Address Display: Support to display the MAC address of the patient monitor.
• ST Values Display: Support for displaying ST values in the parameter tile.
• Patient Private Information: Support for encryption of patient private information sent to the network.
• ST Point Adjustment: Support for adjustment of the ST point on multiple displayed leads.
• NIBP Measurement on Clock: Support for NIBP measurement on the clock.
• Network Application Transmission Priority Setting: Support for network application transmission priority setting.
• ECG Beat Annotation: Support for ECG beat annotation.
• DNS for ADT and LDAP server address: Support for DNS for ADT and LDAP server address.
• Bed No. Issue Correction: Correction of an issue where the Bed No. of the Passport 12m/17m is changed after T1 is pulled out of the monitors.

Performance Data:
Mindray conducted functional and system level testing to evaluate the performance of these modifications. The testing demonstrated that the devices "continue to meet specifications and the performance of the device is equivalent to the predicate." The devices also meet relevant consensus standards (listed in the document).

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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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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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The Passport 17M and Passport 12M patient monitors are intended for monitoring. displaying, reviewing, and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, and heart rate (HR)), respiration rate (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-mvasive 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 (Sy()//Scy(), carbon dioxide (CO2), Oxygen (O2), anesthetic gas (AG), impedance cardiograph (ICG), 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. SvOz/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.

The T1 Patient Monitor is intended for monitoring, displaying, reviewing, storing, and transferring of multiple physiological parameters including ECG (3-lead, or 12-lead selectable, arrhythmia detection, ST Segment analysis, and heart rate (HR)), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpOz), 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 arrhythmia 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
• Passport 17M Patient Monitor ●
• 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.

Each of the three monitors that are the subject of this 510(k) are modified versions of previously cleared Mindray devices. The Passport 17M and Passport 12M were previously cleared in K132075, on April 18, 2014 and the T1 was previously cleared in K123074 on July 3, 2013.

The provided text is a 510(k) Summary for the Mindray Passport Series Patient Monitors (K143195). This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a single study proving that the device meets those criteria.

The core of the submission is that the subject devices are modified versions of previously cleared Mindray devices (K132075 and K123074). The performance data cited refers to functional and system-level testing to evaluate the performance of the modifications and ensure continued adherence to specifications and relevant consensus standards. It does not contain information about a specific single study with acceptance criteria and results.

Given the nature of the K143195 submission as an amendment/modification to existing devices, the information provided focuses on the changes and how these changes do not alter the substantial equivalence to the predicate devices. Therefore, the requested information about acceptance criteria and a detailed study proving the device meets those criteria for the entire device as if it were a novel submission is not explicitly present in the provided text.

However, I can extract information related to the performance characteristics, which serve as implicit acceptance criteria based on the predicate device's performance and general recognized standards for patient monitors.

Here's an attempt to structure the answer based on the available information, noting where specific details are not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with corresponding performance results in a standalone "study summary" format. Instead, it compares the specifications of the subject devices to the predicate device. The "acceptance criteria" are implied to be the specifications of the predicate device and relevant industry standards. The "reported device performance" is generally stated as "Same" or that the new (modified) features "meet specifications" or "are equivalent to the predicate device."

Here's an illustrative table based on the provided "Device Comparison Table," highlighting areas that could be inferred as "acceptance criteria" and "performance":

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

The document does not detail specific sample sizes for test sets for individual parameters or features. It states:

• "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."
• "Mindray has conducted testing to ensure the subject devices meet relevant consensus standards."
• "Mindray has also followed the FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm issues on October 28, 2003."
• "Mindray conducted Wireless functionality testing to ensure the performance of the new wireless modules meet specifications and are equivalent to the predicate device."

There is no mention of data provenance (e.g., country of origin, retrospective/prospective). The studies appear to be internal V&V testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

There is no information provided regarding the number or qualifications of experts used to establish ground truth for any test sets. The testing referenced appears to be engineering/technical validation against specifications and standards rather than clinical studies requiring expert adjudication of data. For interpretations like 12-lead ECG, it is stated that the feature is equivalent to a previously cleared device (K132026), implying that its validation methods would have been established there.

4. Adjudication Method for the Test Set

No adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC comparative effectiveness study is mentioned. This type of study is typically done for diagnostic imaging devices or algorithms where human interpretation is a key component and the AI is intended to assist, altering reader performance. For a patient monitor, the performance validation is typically against direct physiological measurements and established standards.

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

The entire device (the patient monitor) is a standalone system in the sense that its algorithms process physiological signals and present data and alarms. The performance data described ("functional and system level testing") would inherently be evaluating the algorithms and hardware in isolation from a human interpretation loop. For example, SpO2 accuracy is measured against a reference, not against a human's interpretation of SpO2. The 12-lead ECG interpretation, being an automated algorithm output, would be assessed for its accuracy as a standalone function.

7. The Type of Ground Truth Used

Based on the nature of the device (physiological monitor) and the parameters listed, the ground truth would typically be established by:

• Reference standards/equipment: For parameters like NIBP, IBP, SpO2, Temperature, CO2, etc., the device's measurements are compared against highly accurate reference measurement equipment or simulators.
• Known input signals: For features like arrhythmia detection, standardized ECG waveforms with known arrhythmias are often used.
• Clinical data: For capabilities like 12-lead ECG interpretation, ground truth is usually established by highly experienced cardiologists' interpretations, though the document only refers to equivalence to a previously cleared device for this feature.
• Specifications: The "acceptance criteria" are derived from the performance specifications of the predicate device and relevant international standards.

8. The Sample Size for the Training Set

The document does not describe the development or training of AI/ML algorithms. It is a 510(k) for hardware and software modifications to an existing patient monitor, rather than a novel AI/ML device. Therefore, no information on training set sample size is provided. The functions described (e.g., arrhythmia detection, ST segment analysis) typically rely on established signal processing algorithms, not necessarily machine learning requiring explicit "training sets" in the modern sense.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for AI/ML algorithms, this information is not applicable and not provided in the document.

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The Passport Series Patient Monitors, including Passport 8 and Passport 12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment 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 exception of 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 Monitors only.

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

The Passport Series Patient Monitors (including Passport 12) are the developed new series based on the technical platform of the iPM Series patient monitors.

Comparing with the cleared iPM Series Patient Monitors, the WiFi function is added on the subject patient monitors.

Based on the provided text, here's an analysis of the acceptance criteria and study information for the Passport Series Patient Monitors:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study outcomes for each specific function. However, general statements about fulfilling safety and performance standards are made.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of acceptance criteria with corresponding device performance metrics for individual parameters (e.g., specific accuracy for SpO2, heart rate detection sensitivity). Instead, it states that the device "comply[s] with the recognized safety, performance and electromagnetic compatibility standards" and that "The results of all testing demonstrate that the Passport Series Patient Monitors are as safe, as effective, and perform as well as the predicate devices."

The "Test Summary" section mentions the following types of testing conducted to ensure compliance:

• Requirements specification review
• Hardware and Software testing
• Code design and code reviews
• Environmental EMC testing
• Safety testing
• Performance testing
• Hardware and Software validation

Without specific quantifiable acceptance criteria and performance results, a detailed table cannot be constructed from this text. The underlying assumption is that if it performs "as well as the predicate devices," it meets the established performance criteria for those predicates.

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

The document does not specify the sample size used for clinical or performance testing, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective nature). The testing mentioned appears to be primarily related to hardware, software, and regulatory compliance rather than a clinical study with a defined patient cohort.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The text does not describe a clinical study involving human experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. No adjudication method is mentioned as there's no description of a clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with standards, not on demonstrating an improvement in human reader performance with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While "Hardware and Software testing" and "Performance testing" are mentioned, the document does not explicitly detail a standalone algorithm-only performance study in the context of clinical accuracy or diagnostic capability, particularly for functions like arrhythmia detection or ST segment analysis. It implies that the algorithms for these functions are the same as or equivalent to those in the predicate devices.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not specify the type of ground truth used for performance testing. Given the nature of the device (patient monitor displaying physiological parameters), ground truth would likely involve highly accurate reference devices or direct physiological measurements, but this is not explicitly stated. For functions like arrhythmia detection, ground truth would typically be established by expert cardiologists reviewing ECG recordings, but this is not detailed here.

8. The Sample Size for the Training Set

No information about a training set or its sample size is provided. This document describes a medical device seeking 510(k) clearance, which typically relies on demonstrating substantial equivalence to existing devices rather than de novo development requiring extensive machine learning model training details.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned (see point 8), there is no information on how its ground truth might have been established.

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