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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms from compatible physiological monitors. Viewing of non-real time patient clinical data of compatible anesthesia devices (i.e. not indicated for real-time monitoring of clinical data of compatible anesthesia devices).

• Storage and Historical review of patient clinical data and alarms from compatible physiological monitor, and anesthesia devices.

• Printing patient data from compatible physiological monitor, and anesthesia devices.

• Configuration of local settings as well as synchronizing settings across the network to remote compatible physiological monitors.

• Transfer of patient clinical data and settings between several CentralStations.

• Provides a Resting 12 Lead interpretation of previously stored data.

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.

The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors, anesthesia systems and will display, store, print, and transfer information received from the compatible monitors, anesthesia systems.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80, and TM70.

• The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

• The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

• The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

When connected to a compatible anesthesia device, BeneVision CMS can display the parameters, waveforms and alarms of the anesthesia device. The device does not contain bi-directional capabilities for the compatible anesthesia devices.

The BeneVision CMS includes the AlarmGUARD application. AlarmGUARD supports delivering notifications of physiological and technical alarms to clinical professionals' mobile devices. AlarmGUARD is not intended for real time monitoring of patients and is not intended to act as a primary source for alarms.

It appears the provided FDA 510(k) clearance letter and summary for the BeneVision Central Monitoring System (K242728) does not contain specific acceptance criteria, test results (like sensitivity/specificity, accuracy metrics), or detailed study methodologies that directly address how the device's performance meets quantitative acceptance criteria for its intended functions.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K220058) through:

• Comparison of Indications for Use: Showing minor differences (expanded compatibility to include anesthesia systems, but not for real-time monitoring).
• Technological Comparisons: Highlighting changes in operating systems, host configurations, and the addition of features like Multi-Patient Viewer separation and AlarmGUARD support.
• Performance Data Section: This section lists the types of testing conducted but does not provide the results of those tests or specific acceptance criteria met by those results. It merely states that "Software verification and validation testing was conducted" and "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

Therefore, based solely on the provided text, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document confirms the following regarding the study:

• Study Type: Software verification and validation testing, along with specific bench testing.
• Clinical Data/Animal Testing: Not applicable/not required for this submission to establish substantial equivalence. This suggests the clearance relies on non-clinical data and comparison to the predicate.
• Ground Truth: The document implies that the ground truth for software verification and validation would be the design specifications and expected behavior of the system, rather than clinical outcomes or expert consensus on a diagnostic task. For the "Waveform Display Accuracy from compatible Anesthesia Machine," the ground truth would likely be the direct output from the anesthesia machine itself.

What is present in the document that somewhat relates to your request:

• "Bench Testing" section (Page 19): This lists specific tests performed:
  • AlarmGUARD IEC 60601-2-27
  • AlarmGUARD IEC 60601-1-8
  • AlarmGUARD Human Factors
  • Waveform Display Accuracy from compatible Anesthesia Machine

To fulfill your request as best as possible with the given information, I will have to state that many details are explicitly absent from this public 510(k) summary.

Here's a structured response based on the provided document, indicating what information is present and what is absent:

Device Acceptance Criteria and Performance Study Summary (K242728)

Based on the provided FDA 510(k) Clearance Letter and Summary, detailed quantitative acceptance criteria and specific performance metrics (like accuracy, sensitivity, specificity) for the BeneVision Central Monitoring System are not explicitly presented. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K220058) through verification and validation of software and specific bench testing.

The document states that "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance 'Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff'." It also mentions that "Verification of the BeneVision Central Monitoring System was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided document for any of the listed tests (AlarmGUARD, Waveform Display Accuracy, general software V&V).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given that no clinical data was used or required, the "data" would be synthetic, simulated, or derived from direct device connections during bench testing.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable / Not specified. The document does not describe the use of human experts to establish ground truth for a diagnostic task or for the performance evaluation of this central monitoring system. The focus is on software function and electro-mechanical performance validation against design specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. No adjudication method is mentioned as human reader input for a test set is not described.

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

• No. The document explicitly states that "Clinical testing is not required to establish substantial equivalence to the predicate device" and does not mention any MRMC study. This device is a central monitoring system displaying physiological data, not an AI diagnostic tool requiring MRMC studies for improved human reader performance.

6. Standalone Performance (Algorithm Only)

• The "performance data" section lists "Software Verification and Validation Testing" and "Bench Testing" (including "Waveform Display Accuracy from compatible Anesthesia Machine"). These tests conceptually represent 'standalone' performance in that they evaluate the device's technical functions directly. However, no specific quantitative standalone performance metrics (e.g., classification accuracy, sensitivity, specificity for any internal algorithms) are provided in this summary beyond the statement that v&v was conducted to ensure the product "works as designed."

7. Type of Ground Truth Used

• The ground truth for the device's performance appears to be:
  • Design Specifications: For general software verification and validation.
  • External Reference Standards/Simulators: For tests like "Waveform Display Accuracy" (e.g., comparing the displayed waveform to the known, true signal generated by a simulator or the anesthesia machine itself).
  • International Standards: For AlarmGUARD functionality (e.g., IEC 60601-2-27, IEC 60601-1-8).

8. The Sample Size for the Training Set

• Not applicable / Not specified. This document describes a traditional medical device (patient monitoring system software) rather than a machine learning/AI device that typically requires a distinct "training set." Therefore, no training set size is mentioned.

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

• Not applicable / Not specified. As no training set for an AI/ML model is indicated, there is no mention of how its ground truth would be established.

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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms .
• . Storage and Historical review of patient clinical data and alarms
• Printing of real time and historical patient data
• Configuration of local settings as well as synchronizing settings across the network to a remote device
• Transfer of patient clinical data and settings between several CentralStations
• Provides a Resting 12 Lead interpretation of previously stored data

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80 and TM70.

The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, . SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

. The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG. SpO2. NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

The provided text is a 510(k) premarket notification summary for the BeneVision Central Monitoring System. It details the device, its intended use, comparison to predicate devices, and various testing performed to demonstrate substantial equivalence.

However, the document does not contain information about an AI/algorithm where acceptance criteria and specific performance metrics (like sensitivity, specificity, or AUC) or information related to multi-reader multi-case (MRMC) comparative effectiveness studies would typically be found. The changes describe modifications to the software for an existing central monitoring system, primarily related to operating system compatibility, supported monitors, and the addition of a "Resting 12 Lead interpretation of previously stored data" feature.

The document discusses "Software Verification and Validation Testing" and "Bench Testing" to ensure the device meets its specifications, but these tests are for the overall system's functionality and accuracy, not for an AI component that would require the level of detail requested in the prompt.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance for an AI model, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device, as this information is not present in the provided text.

The information that is available in the document regarding testing is general:

• Software Verification and Validation Testing: Conducted "as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This ensures the product "works as designed" and validates its "design and performance."
• Bench Testing: Conducted "functional and system level testing to validate the performance of the devices." The results "show that the subject device meets its accuracy specification, and is substantially equivalent to the predicate device."
• Consensus Standards: The device meets relevant consensus standards, specifically mentioning IEC 60601-2-25:2011 for electrocardiographs.

The document explicitly states:

• Animal Testing: "Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."
• Clinical Data: "Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device."

Without an AI/ML component described with specific performance criteria and a study demonstrating its meeting those criteria, the detailed information requested in the prompt cannot be extracted from this document.

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The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The monitors are additionally intended for use in transport situations within hospital environments.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥40 kg and on pediatrics ≥5 kg and

The IntelliVue Patient Monitors MX500 and MX550 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located at the patient bedside vicinity and can also be used during patient transport inside hospitals.

The monitors have a color display with touchscreen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

Here's a breakdown of the acceptance criteria and the study information for the Philips IntelliVue Patient Monitors MX500 and MX550 based on the provided FDA 510(k) summary:

This submission is a 510(k) for modifications to an existing device, the IntelliVue Patient Monitors MX500 and MX550. The acceptance criteria and supporting studies primarily focus on demonstrating that the modifications do not introduce new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an update to an existing device focusing on integrating new measurement modules (Masimo O3, IRMA CO2, ISA CO2) and updating EMC standards, the "acceptance criteria" are primarily related to meeting established performance standards for patient monitors and demonstrating that the new modules function as intended without compromising the overall device safety or efficacy. The document doesn't present specific numerical acceptance criteria for all physiological parameters of the overall monitor, but rather confirms compliance with recognized standards.

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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms
• Storage and historical review of patient clinical data and alarms
• Printing of real time and historical patient data
• Configuration of local settings as well as synchronizing settings across the network to a remote device
• Transfer of patient clinical data and settings between several CentralStations

The Bene Vision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors; The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80, and TM70.

• The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.
• The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.
• The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.
• The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG, SpO2, NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can configure and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wired), Wireless WIFI (WLAN), and Wireless WMTS.

The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The BeneVision Central Monitoring System supports bi-directional configuration of the compatible monitors. No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors or the TM80/TM70 Telemetry Monitors.

The BeneVision Central Monitoring System consists of the following components:

• 1. CentralStation
• 2. ViewStation
• 3. WorkStation
• 4. CMS Viewer
• 5. Telemetry Systems (TMS 6016, Telepak-608, TMS60, TM80, TM70)

The TMS 6016, Telepak-608, TMS60 telemetry monitoring systems operate in the 608M WMTS frequency range within a defined coverage area. All of the supported telemetry systems transmit data to the CentralStation for processing, display, and alarm.

The TM80 telemetry monitor uses the Wireless WIFI connection to transmit data to the CentralStation for display, storage, and printing.

The TM70 telemetry monitor operates in the 608M or the 1.4G WMTS frequency range within a defined coverage area, and transmits data to the CentralStation for display, storage, and printing.

The provided document is a 510(k) premarket notification for the BeneVision Central Monitoring System. It describes the device, its intended use, and comparisons to predicate devices, along with testing undertaken to demonstrate substantial equivalence. However, it does not explicitly define "acceptance criteria" in the format of a table with quantitative metrics for device performance (e.g., sensitivity, specificity, accuracy for an AI/algorithm). Instead, it explains that the modifications to the device (primarily updated host computers, increased connection/monitor support, and changes to telemetry modules and their wireless components) were assessed through functional and system-level testing to ensure they continue to meet specifications and have equivalent performance to the predicate devices.

The document is a regulatory submission for a medical device that monitors physiological data, not an AI/algorithm for diagnostic purposes, which typically involves sensitivity, specificity, or ROC curve analysis. The device's "performance" here relates to its ability to accurately acquire, display, store, print, and transfer physiological data, and its wireless connectivity capabilities, rather than a diagnostic accuracy measure that would be subject to stringent acceptance criteria for an AI model.

Therefore, many of the specific questions regarding AI/algorithm performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not directly applicable to this type of device submission as described in the provided text.

Based on the content, here's what can be extracted and inferred:

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

The document doesn't provide a table of quantitative acceptance criteria for "device performance" in the way one would expect for an AI algorithm (e.g., a specific sensitivity threshold). Instead, the acceptance criteria are implicitly tied to the device's ability to maintain its intended functions and specifications when new components or features are introduced, demonstrating "substantial equivalence" to predicate devices. The reported performance is the successful completion of various tests and compliance with relevant standards.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified quantitatively. The document refers generally to "functional and system level testing," "bench testing," and "wireless functionality testing." For wireless coexistence, it mentions testing was performed for "up to 16 wireless medical devices... within a single AP" for TM80, and "up to 14 wireless medical devices per single AP for 608 MHz and 16 wireless medical devices per single AP for 1.4 GHz" for TM70. For wireless networking stability, it mentions "Each of the TM70 roam 30 times, at least 3 TM70s roam at the same time." These are details about the test conditions (number of devices tested simultaneously or repetitively) rather than a statistical "sample size" of patient data for algorithm performance.
• Data Provenance: Not applicable in the context of physiological data for an AI model. The testing is primarily bench-top (in vitro) and system-level, concerned with internal device performance and wireless communication, not analysis of patient data by an algorithm to produce a clinical output. The device itself collects patient data, but the testing described here focuses on the device's functional integrity.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. This submission is for a central monitoring system and telemetry modules, not a device that relies on expert interpretation to establish a "ground truth" for an AI algorithm's diagnostic output. The "ground truth" for the device's performance would be engineering specifications and standards compliance, verified through bench testing and measurements.

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

Not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in ground truth labeling for AI model training or testing. This device's testing relates to hardware and software functionality and compliance with engineering standards.

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. This is not an AI-assisted diagnostic device for human readers.

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

Not applicable. The "BeneVision Central Monitoring System" is a system for displaying and managing physiological data, not a standalone AI algorithm. It's a medical device system, where the listed software functions for pace detection or arrhythmia analysis are integral parts of the physiological monitoring, not separate AI algorithms in the sense of a standalone diagnostic tool. The document states "No data processing is done by the BeneVision Central Monitoring System for data received from compatible monitors." This implies the system primarily relays and displays data without independent algorithmic analysis beyond what the individual monitors (e.g., TMS60, TM70, TM80) might perform for parameters like arrhythmia or ST-segment analysis. The "software pace detection" mentioned is an update to how the hardware detects pacemakers, not an AI diagnostic algorithm.

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

The "ground truth" for this device's performance is not derived from clinical expert consensus or pathology. Instead, it is based on:

• Engineering specifications and design requirements: The device's components and system are tested against predefined performance parameters (e.g., signal accuracy, wireless range, data integrity, latency, alarm thresholds).
• Industry and regulatory standards: Compliance with consensus standards such as IEC 60601-1-2 (EMC), IEC 60601-2-27 (ECG monitoring), AAMI TIR 69 (wireless coexistence), and FCC certifications (wireless performance).
• Predicate device equivalence: Demonstrating that the modified device performs "equivalently" to previously cleared, substantially equivalent devices.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set" in the common sense (i.e., for a deep learning model). The software is developed using traditional software engineering processes (V&V testing).

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

Not applicable. As there's no stated AI/ML training set, the concept of establishing ground truth for it doesn't apply to this submission.

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The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment.

The MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment.

The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment.

The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

The transcutaneous gas measurement (tcGas) with the M1018A plug-in module is restricted to neonatal patients only.

BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The IntelliVue NMT Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800 and IntelliVue Multi-Measurement Module X3 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, ScvO2, spirometry, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. Several monitor models can also be used mobile, during patient transport inside or outside of hospitals.

The monitors have a color display with touch-screen and/or keys and a navigation point as a primary input device. They also support further local input devices such as specialized remote control, keyboard, and mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

With the current software Rev. N.0 the following modifications have been introduced:

• Implementation of the existing feature Alarm Advisor into the IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3. Alarm Advisor provides feedback on recurring and continuous alarm limit violations based on configured criteria. The information provided by the Alarm Advisor supports device operator in adapting alarm limits more specifically. This is the same functionality as that in other IntelliVue Patient Monitors: MP5, MP5SC, MX400, MX430, MX450, MX500, MX550, MX700, and MX800 (cleared with K161531).
• Modification of a few specific elements of the Graphical User Interface (GUI) of the IntelliVue Patient Monitors MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, and the Intelli Vue Multi-Measurement Module X3:
  • The key 'Silence' has been renamed to 'Acknowledge',
  • A new default configuration for the Pause/Switch off of alarms via 'Acknowledge' key combined with a specific pop-up window has been added to all monitor models,
  • New default configurations of visual alarm indicators with other colors and flashing behavior of the alarm numerics and limits have been added.

The provided document is a 510(k) premarket notification from Philips Medizin Systeme Boeblingen GmbH to the FDA for their IntelliVue Patient Monitors. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and addressing minor software modifications, specifically the implementation of an "Alarm Advisor" feature and GUI changes related to alarm management.

The document does not contain the specific details required to answer all parts of your request, particularly regarding clinical performance studies with specific acceptance criteria, sample sizes for test and training sets, expert consensus, or MRMC studies for an AI device. This is because the submission is for a patient monitor and its software updates, not an AI-powered diagnostic device in the sense that would require such extensive clinical validation to demonstrate improved human reader performance or standalone algorithm performance.

However, I can extract information related to the acceptance criteria and study proving the device meets its acceptance criteria, based on the scope of this type of submission.

Here's an analysis based on the provided text, while acknowledging the limitations for a full AI device performance study:

Acceptance Criteria and Device Performance (as evident from this 510(k) submission):

For this type of device (patient monitors with software updates), the "acceptance criteria" and "device performance" are primarily demonstrated through compliance with recognized standards, hazard analysis, and functional/regression testing rather than a clinical trial with a defined performance metric like sensitivity/specificity for a diagnostic AI.

Study Details (based on the provided document):

Given that this is a 510(k) for patient monitors with minor software updates, the "study" is primarily a series of verification and validation (V&V) activities focused on engineering and software aspects, rather than a clinical trial for an AI diagnostic.

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify a "test set" in the context of a dataset for an AI model. Instead, it refers to V&V activities that include:
     • Hazard Analysis Testing: "All specified pass/fail criteria have been met." (No specific sample size of incidents/scenarios mentioned, typically an engineering analysis).
     • Functional System Level Tests: Performed on a variety of monitor models (MP5, MP5SC, MX100, MX400, MX430, MX450, MX500, MX550, MX700, MX800, Multi-Measurement Module X3) for the new features (Alarm Advisor, blinking numerics, Alarm Acknowledge, Pause/Switch off Alarms). No specific number of test cases or "patients" is provided.
     • Regression Tests: Performed on the same range of monitor models to ensure unchanged functions still work.
   • Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The tests are performed on the device itself and its software.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • Not described as "ground truth" establishment in this context. For usability testing, it mentions "expert reviews" as part of formative evaluations, but the specific number and qualifications of these experts are not detailed. These would typically be human factors engineers, clinical specialists, or design experts.

3. Adjudication Method for the Test Set:

   • Not applicable as there is no "test set" of clinical cases requiring adjudication. The V&V activities are based on engineering specifications and standard compliance.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This submission is for patient monitors and their alarm management and GUI features, which do not involve diagnostic interpretation in that manner. The "Alarm Advisor" provides feedback on alarm limit violations, which is a clinical decision support tool related to device settings, not an image interpretation aid.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:

   • Yes, to an extent, in the sense that the new software features were functionally tested independently of human interaction (e.g., "Functional tests... All tests have been passed"). The "Alarm Advisor" functionality and GUI changes needed to perform as specified by the algorithm/software design. However, this is not a "standalone performance study" in the context of an AI diagnostic that might output a diagnosis or risk score. It's more about verifying software logic and output.

6. The Type of Ground Truth Used:

   • Engineering Specifications and Standards Compliance. For the new features and existing functionalities, the "ground truth" is whether the software performs according to its design specifications, established industry standards (e.g., IEC 60601-1-8 for alarms), and internal quality requirements. For usability, "user feedback" (from focus groups, usability tests) serves as the basis for improvement.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI model that undergoes a "training phase" from a clinical dataset in the traditional machine learning sense. The software development process involves design, coding, and V&V activities.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as above.

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The Philips Multi-Measurement Module (MMX) is for use with Philips IntelliVue Patient Monitors.

The Multi-Measurement Module, with its host patient monitor, is intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare facilities.

It sends processed measurement data (for example, measurement waves and numerics) to the monitor screen, generates alerts, and supports the transfer of patient data between monitors.

The Multi-Measurement Module is intended for use by trained healthcare professionals in a hospital environment. The Multi-Measurement Module is additionally intended for use in transport situations within hospital environments together with its host patient monitor.

The Multi-Measurement Module is only for use on one patient at a time. It is not intended for home use. It is not a therapeutic device. The Multi-Measurement Module is for prescription use only.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is 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.

The newly introduced IntelliVue Multi-Measurement Module MMX acquires multiple physiological patient signals, sends processed measurement data (for example, measurement waves and numerics) to the host monitor screen, generates alerts, and supports the transfer of patient data between monitors.

The device, together with its compatible host monitor, offers a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. It can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals.

The measurement sensors are applied at diverse body locations, depending on the physiological parameters monitored.

The new device has the same range of functions as the legally marketed predicate devices; it provides the same measurement parameters as the predicates.

The Multi-Measurement Module MMX provides multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The Philips IntelliVue Multi-Measurement Module MMX is a device intended for monitoring, recording, and alarming multiple physiological parameters in adults, pediatrics, and neonates within healthcare facilities. The following details describe its acceptance criteria and the study that proves the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a validation and verification (V&V) study, but it does not present a single consolidated table of acceptance criteria with corresponding performance statistics. Instead, it refers to fulfilling requirements of various standards and guidance documents. Based on the "Summary of V&V Activities" section, the acceptance criteria are generally defined as meeting all applicable requirements of recognized consensus standards and FDA guidance documents, and that "All specified pass/fail criteria have been met."

Since specific numerical acceptance criteria and reported device performance values are not explicitly listed in a table, here's a conceptual representation of what such a table would contain, based on the types of testing mentioned:

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size for any specific test set beyond "a minimum of three devices" for non-invasive blood pressure intra-device variability testing.
The origin of the data (country, retrospective/prospective) is not specified. The testing appears to be conducted by the manufacturer, Philips Medizin Systeme Boeblingen GmbH, based in Germany. The nature of the V&V activities suggests prospective testing against established standards and internal specifications.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. The validation relies on meeting criteria defined by recognized consensus standards and FDA guidance rather than expert consensus on individual cases. For parameters like SpO2 and NBP, ground truth would typically be established by validated reference methods (e.g., co-oximetry for SpO2, invasive arterial pressure for NBP).

4. Adjudication Method

No adjudication method is mentioned, as the validation strategy is based on direct measurement against technical standards and reference methods, not subjective expert review of cases.

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

An MRMC comparative effectiveness study was not conducted. This device is a physiological monitoring module, and its performance is evaluated against technical standards and reference measurements, not by human reader interpretation of outputs requiring AI assistance.

6. Standalone (Algorithm Only) Performance

A standalone performance evaluation was done. The entire "Summary of V&V Activities" section describes the testing of the device itself (the IntelliVue Multi-Measurement Module MMX) against various technical standards without human-in-the-loop intervention for the core physiological measurements. The measurements (ECG, respiration, SpO2, NBP, invasive pressure, temperature, CO2) are automatically processed and displayed by the device.

7. Type of Ground Truth Used

The ground truth used for testing is primarily based on:

• Reference Standards: Performance specifications defined by international standards (e.g., IEC, ISO, AAMI/ANSI) for physiological measurement devices.
• Reference Methods: For parameters like SpO2 and NBP, the ground truth would typically involve comparison against highly accurate and validated reference measurement techniques (e.g., co-oximetry for SpO2, intra-arterial catheter for NBP).
• Internal Specifications: Philips' own defined specifications for the device's behavior and performance.

The document does not mention pathology, outcomes data, or expert consensus on patient cases as ground truth for the device's technical validation.

8. Sample Size for the Training Set

The document does not mention a training set. This document describes the validation of a medical device with established algorithms for physiological parameter measurement, not a machine learning or AI-based system that typically requires a distinct training phase with a large dataset. The underlying algorithms for most physiological monitors are well-established and are typically validated through engineering and clinical testing rather than "training" in the machine learning sense.

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

As no training set is described or implied for this type of medical device's validation, no information is provided on how its ground truth would have been established.

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The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions. and for patients who are well or poorly perfused.

The derived measurement Pulse Pressure Variation (PPV) is intended for use with sedated patients receiving controlled mechanical ventilation and which are mainly free from cardiac arrhythmia.

The PPV measurement is validated for use with adult patients only.

The measurement extension adds physiological measurements (Microstream CO2 and optionally temperature, invasive blood pressure and cardiac output) to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals.

The measurement extension can only function when it is connected to a dedicated host device.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management.

The devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals.

The measurement sensors are applied at diverse body locations, depending on the actual physiological parameters monitored.

The MX100 and X3 provide multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The modification that is subject of this Premarket Notification adds the derived measurement PPV (pulse pressure variation), which is calculated from beat-to-beat arterial pressure values.

The Microstream Extension 867041 adds to the dedicated host device (IntelliVue Patient Monitor or Multi-Measurement Module) physiological measurements: Microstream CO2, and optionally dual invasive pressure and temperature.

The measurement extension is not a stand-alone device; it can only function when it is connected to a dedicated host device.

The modified Microstream Extension now provides the additional optional measurement cardiac output to the host devices.

The provided text contains information about the Philips IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, and IntelliVue Microstream Extension 867041. However, it does not contain specific acceptance criteria values or the results of a study designed to prove the device meets those specific criteria in the format requested, especially for performance metrics like sensitivity, specificity, or reader improvement.

The document focuses on explaining changes made to the devices (addition of PPV measurement and cardiac output measurement), demonstrating substantial equivalence to predicate devices, and listing various verification and validation (V&V) activities performed. These V&V activities generally ensure the device functions as intended and meets safety standards, rather than providing specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy.

Therefore, I cannot populate the table and answer all questions in the requested format based on the provided text.

Here's what can be extracted and what information is missing:

Missing Information (Crucial for the Request):

• Specific Acceptance Criteria Values: The document mentions that "All applicable requirements have been met" and "All specified pass/fail criteria have been met," but it does not specify what those numerical criteria are for the derived measurements (PPV, Cardiac Output accuracy, etc.). For instance, it doesn't say "PPV accuracy must be within X%" or "Cardiac Output repeatability must be less than Y%."
• Reported Device Performance: Due to the absence of specific acceptance criteria, corresponding reported device performance values are also not explicitly stated in a quantifiable manner for diagnostic type performance. It states "The modified devices perform according to the specified criteria," but the numerical results are not provided.
• Sample Size for Test Set: Not mentioned for any performance-related tests involving patient data.
• Data Provenance (Country, Retrospective/Prospective): Not mentioned.
• Number of Experts for Ground Truth: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Adjudication Method: Not mentioned.
• Multi-Reader Multi-Case (MRMC) Study: No mention of an MRMC study or AI assistance. The devices are patient monitors, not AI diagnostic tools that typically involve human readers interpreting images with or without AI assistance.
• Standalone Performance: The performance testing mentioned ("Verification of PPV calculation by comparison to predicate device", "Verification of accuracy and repeatability for right heart measurement" etc.) relates to the device's accuracy in measuring physiological parameters, which is inherently standalone measurement performance. However, specific quantifiable results are not provided.
• Type of Ground Truth: For the "Performance testing of derived measurement PPV" and "Performance testing of Cardiac Output (C.O.)", the ground truth seems to be established against the predicate device's performance or standard measurement techniques. For example, "Verification of PPV calculation by comparison to predicate device."
• Sample Size for Training Set: Not applicable as this is a patient monitor, not an AI or machine learning model that would typically have a separate "training set" in the diagnostic sense.
• How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, here's what can be stated:

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

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text for any performance-related tests.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The ground truth for performance was primarily established by comparison to predicate devices or specified criteria derived from standard measurement techniques, rather than expert consensus on patient data.

4. Adjudication method for the test set:

• Not applicable/Not specified. The testing described largely involves verification against technical specifications and predicate device performance, not independent adjudication of clinical interpretations.

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:

• No. The devices are patient monitors that acquire and display physiological parameters, and calculate derived measurements (PPV, Cardiac Output). They are not described as AI-assisted diagnostic tools requiring MRMC studies for human reader improvement.

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

• Yes, implicitly. The performance verification of PPV calculation and Cardiac Output accuracy (e.g., "Verification of accuracy and repeatability") are tests of the device's standalone measurement capabilities. However, specific numerical results of these tests (e.g., actual accuracy percentages or repeatability values) are not provided.

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

• Primarily comparison to predicate device performance and compliance with recognized consensus standards and internal specifications. For example, "Verification of PPV calculation by comparison to predicate device" and "All specified test requirements have been met. The modified devices perform according to the specified criteria that are the same as those for the predicate devices."

8. The sample size for the training set:

• Not applicable. These are patient monitoring devices with specified measurement algorithms, not machine learning models that undergo training on a "training set" in the typical sense.

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

• Not applicable, as there is no mention of a "training set" for AI/ML algorithms.

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Indications for Use statement for the MX100 and X3:

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.

Indications for Use statement for the Hemodynamic Extension 867039:

The measurement extension adds physiological measurements to a dedicated host device. It is intended for use by trained healthcare professionals for adult, pediatric, and neonatal patients in a hospital environment and for transport inside hospitals. The measurement extension can only function when it is connected to a dedicated host device.

The new IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, and Hemodynamic Extension 867039 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The devices offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They can be located in the patient vicinity at the bedside or can be used mobile, during patient transport inside hospitals. The measurement sensors are applied at diverse bodily locations, depending on the actual physiological parameters monitored.

The new devices have the same range of functions as the legally marketed predicate devices. They use the same measurement parameters as the predicates.

Whereas the predicate devices optionally provide one invasive pressure, the new devices optionally provide two invasive pressures (dual pressure) that can be measured with one pressure connector.

The MX100 and X3 provide multiple non-invasive and invasive measurements: ECG (including arrhythmia and ST), respiration, SpO2, NBP, dual invasive pressure, temperature, and CO2.

The Hemodynamic Extension 867039 adds optional measurements: dual invasive pressure, temperature, and cardiac output /continuous cardiac output to the host device. The measurement extension can only function when it is connected to a dedicated host device.

Specifications of all measurement characteristics, including measurement principles, methods, algorithms, and all detailed performance specifications and measurement alarm specifications, are the same as those in the predicate devices. The new devices reuse unchanged existing accessories of the predicates.

The new IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 are compact, rugged, lightweight monitors with built-in measurements. The X3 can be used in two ways: as a multi-measurement module for the Philips IntelliVue family of patient monitors and as a stand-alone monitor.

The MX100 and X3 have a 6.1' TFT flat panel color display with a multi-finger touchscreen as input device.

The MX100 and X3 can interact with the Central Station via LAN or wireless link.

The new Transpac IV Dual IBP Cable 453564588501 is a reusable cable intended to connect two ICU Transpac pressure transducers with one of the new Philips measuring devices (Patient Monitor MX100, Multi-Measurement Module X3, or Hemodynamic Extension 867039). The cable transmits analog voltage signals from the pressure transducers to the Philips device and provides electrical power from the Philips device to the transducers.

Here's a breakdown of the acceptance criteria and study information for the Philips IntelliVue Patient Monitor MX100, Multi-Measurement Module X3, and IntelliVue Hemodynamic Extension 867039, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in a concise format. Instead, it refers to fulfilling requirements of various recognized consensus standards and device-specific guidance documents. The general statement is:

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

The document does not explicitly state the sample sizes used for various test sets in terms of patient numbers or data records.

• NIBP testing: "minimum of three devices" were compared for intra-device variability.
• Data Provenance: Not specified. The document describes a series of engineering tests and compliance to standards, rather than clinical trials with patient data.

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

This information is not provided in the document. The studies described are primarily engineering verification and validation against established standards and predicate device specifications, rather than relying on expert ground truth for patient data in the typical sense of a diagnostic AI product.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described is against defined technical specifications and standards, not a diagnostic task requiring adjudication of expert interpretations.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This device is a patient monitor, not an AI-assisted diagnostic tool that aids human readers in interpreting medical images or data. The focus is on the device's accuracy and reliability in measuring and displaying physiological parameters.

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

The device is inherently a "standalone" system in terms of its algorithmic performance for measuring physiological parameters. The studies described (e.g., NIBP accuracy, SpO2 accuracy, respiration rate accuracy) directly assess the device's algorithms and hardware without requiring human intervention in the measurement process itself, though it is intended for use by healthcare professionals.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance testing appears to be based on:

• Reference Standards: For parameters like NIBP, a "comparison to the intra-arterial reference standard for mean blood pressure" was used.
• Predicate Device Specifications: The "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
• Consensus Standards: Performance was evaluated against recognized consensus standards (e.g., IEC, AAMI, ISO) which define acceptable limits for accuracy and performance.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The document describes a medical device, not a machine learning or AI model that requires a "training set" in the conventional sense. The device's algorithms are likely based on established physiological principles and engineering design, not data-driven machine learning models that are "trained."

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

This information is not applicable and not provided, as there is no mention of a "training set" for a machine learning algorithm.

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The ACIST RXi Mini is indicated for obtaining intravascular pressure measurements for use in the diagnosis and treatment of coronary and peripheral artery disease. The ACIST Navvus Catheter is intended for use with the ACIST RXi Mini.

ACIST RXi Mini consists of a 1.) Navvus Interface, which receives the pressure signal sensed by the Navvus Catheter, and a 2.) Processing Unit, which converts the optical sensor pressure signal into an analog pressure signal that can be read by a third party hemodynamic system in real-time. These two hardware components are intended to be located on or around a patient bed, and multiple mounting options are available to accommodate different workflows. Both components contain software.

The two modules are connected using the Navvus Interface cable, which contains both a fiber optic cable and an electrical signal (communication) cable. A hemodynamic cable is connected to the Processing Unit and is plugged into the appropriate channel programmed to accept the distal pressure in the hemodynamic system. The power cord is plugged into the Processing Unit and is then connected to the mains power source.

The provided text describes a 510(k) submission for the ACIST RXi Mini System, a medical device for measuring intravascular pressure. However, the document focuses on non-clinical tests (bench testing, electrical, software verification) to demonstrate substantial equivalence to a predicate device. It does not present clinical study data or specific acceptance criteria for device performance.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) cannot be populated from the provided information.

Here's a summary based on the available text:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document refers to "bench testing," "electrical testing," "software verification," and "design validation" which are non-clinical and do not typically involve human patient "test sets" in the context of diagnostic accuracy.
• Data Provenance: The tests were non-clinical, likely conducted at the manufacturer's facilities or accredited labs. Country of origin for data is not applicable as it's not patient data. Retrospective/Prospective: Not applicable as it's non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. As this was non-clinical engineering and software testing, there was no "ground truth" established by medical experts in the context of patient diagnosis. Performance was assessed against engineering specifications and regulatory standards.

4. Adjudication method for the test set

• Not applicable. There was no clinical imagery or patient data requiring expert adjudication.

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

• No. This device is a transducer system for measuring intravascular pressure, not a diagnostic imaging AI system. Therefore, an MRMC study or AI assistance evaluation is not relevant.

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

• Yes, in a sense. The "standalone" performance refers to the device's ability to accurately convert the optical sensor pressure signal into an analog pressure signal. This performance was validated through non-clinical testing (bench testing, electrical testing, software verification, design validation) to show it functions as intended by itself, without human interpretation of its output beyond ensuring it meets specifications.

7. The type of ground truth used

• The "ground truth" for the non-clinical tests would have been engineering specifications, established standards (e.g., IEC 60601-1, IEC 60601-1-2), and design requirements. The device’s output was measured against these predefined technical benchmarks rather than against a medical outcome or expert consensus on clinical data.

8. The sample size for the training set

• Not applicable. This device is a hardware and software system for signal processing, not a machine learning or AI model that requires a "training set" of data in the typical sense.

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

• Not applicable, as there was no training set in the context of machine learning.

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The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients.

The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment.

The monitor is also intended for use during patient transport inside and outside of the hospital environment.

The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only.

The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).

ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.

The IntelliVue Patient Monitors MP2, MP5, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450, MX500, MX550, MX600, MX700, MX800 and the Multi-Measurement Module X2 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and noninvasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, Sv02, Scv02, spirometry, EEG, BIS, NMT, and gas analysis.

The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. Several monitor models can also be used mobile, during patient transport inside or outside of hospitals.

The monitors have a color display with touch-screen and/or keys and a navigation point as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. External displays can be connected to a built-in video port to provide an adaptive duplicate image of the primary display.

The monitors can interact with several compatible external measuring and auxiliary devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link.

The software of the IntelliVue Patient Monitors MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450, MX550, MX600, MX700, and MX800, was modified to provide the feature Alarm Advisor. Legally marketed IntelliVue Patient Monitors provide the features Graphic Trends (displays for configurable time in a graphic form patient measurement data to show how this data develops over time) and Alarm Limits window (displays in a graphic form 15 min trends, alarm limits, and measurement values, and allows operator changing the limits manually on the basis of the displayed information).

In the new software Rev. M.0 of the subject devices MP5 to MX800, these functionalities were combined in one feature called Alarm Advisor in order to display in a graphic format for a configurable time trends, alarm limits, and measurement values and to allow operator changing the alarm limits manually.

Compared to Graphic Trends and Alarm Limits window, Alarm Advisor provides two enhancements: it gives feedback in case of recurring or continuous alarm limit violations in form of a notification and it allows operator to try out new alarm limits before setting them, with the help of the graphical trend information. When an operator tries a new alarm limit, Alarm Advisor shows the effect the new alarm limit would have had on the occurred alarm limit violations. The Alarm Advisor itself does not propose any specific alarm limit values. It also does not make any automatic alarm limit settings.

The combination of existing trending and alarm limit setting features and their enhancement joint in the Alarm Advisor feature, supports clinician in adapting alarm limits more specifically for individual patients.

The software of the IntelliVue Patient Monitors MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX400, MX430, MX450, MX500, MX550, MX600, MX700, MX800, and the IntelliVue X2 Multi-Measurement Module was additionally modified to support configurable source of QRS tone. In the previously cleared IntelliVue Patient Monitors, the QRS tone can be derived from either HR or Pulse, depending on which is currently selected as the alarm source. In the modified IntelliVue Patient Monitors software Rev. M.0 this limitation has been eliminated so that the source of the QRS tone is free selectable between HR and Pulse.

The provided text describes software modifications to Philips IntelliVue Patient Monitors and the Multi-Measurement Module X2, focusing on the "Alarm Advisor" feature and configurable QRS tone source. The documentation outlines the verification and validation (V&V) activities undertaken to demonstrate the substantial equivalence of these modified devices to their previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study as presented in the document:

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

The document doesn't provide a specific table contrasting acceptance criteria with numerical performance data in the traditional sense of diagnostic accuracy (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicit in the pass/fail criteria of the various tests conducted, and the reported "performance" is that these criteria "have been met."

The primary acceptance criteria seem to be related to:

• Functionality: Correct operation, control, configuration, and functioning of the new features (Alarm Advisor and configurable QRS tone source) as specified and according to labeling claims.
• Safety and Effectiveness: Maintaining safe and effective operation of unchanged functions and adhering to relevant safety standards (e.g., IEC 60601-1-8 for the alarm system).
• Reliability: Meeting all defined reliability requirements and performance claims.

Since specific numerical performance metrics are not given, a table like the one requested cannot be fully constructed. However, we can represent the described V&V outcomes:

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" in terms of patient data or case numbers. The V&V activities described are primarily software testing, including functional tests, regression tests, and hazard analysis.

• Sample Size: Not applicable in the context of patient data for performance evaluation in this document. The "sample" would be the software itself and its functionalities.
• Data Provenance: Not applicable as it's not a study on clinical data. The tests were likely conducted on simulated environments or test benches in a laboratory setting by the manufacturer, Philips Medizin Systeme Boeblingen GmbH (Germany).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Since the V&V activities relate to software functionality and technical standards rather than clinical diagnostic performance, the "ground truth" would be established by technical specifications, design documents, and relevant industry standards (e.g., AAMI EC 11 for ECG, IEC 60601-1-8 for alarms). Expert clinical review for establishing a "ground truth" on patient data is not described for these specific software modifications.

4. Adjudication method for the test set:

Not applicable. The V&V activities described are technical tests against predefined internal and external (standards-based) criteria, not clinical case adjudication.

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:

No, an MRMC comparative effectiveness study was not done. The device modifications ("Alarm Advisor" and configurable QRS tone) are enhancements to existing monitoring features and do not describe an AI component that would assist human readers in interpretation or diagnosis. The Alarm Advisor
"supports clinicians in adapting alarm limits more specifically for individual patients" by providing graphical trend information and allowing "trying out" new alarm limits, but it "does not propose any specific alarm limit values" nor "make any automatic alarm limit settings." Therefore, it's not an AI-assisted diagnostic tool as typically evaluated by MRMC studies.

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

No, a standalone algorithm-only performance study was not done for a diagnostic algorithm. The Alarm Advisor and configurable QRS tone are integrated software features of a patient monitor, and their performance is evaluated in the context of their functional correctness and compliance with specifications, not as a standalone diagnostic algorithm.

7. The type of ground truth used:

The ground truth for the V&V activities was based on:

• Technical Specifications: Internal design documents and functional requirements for the software features.
• Industry Standards:
  • AAMI EC 11 for ECG measurement (mentioned in the Indications for Use for various monitor models).
  • IEC 60601-1-8 for the alarm system (specifically mentioned for regression tests of the alarm system).
• Hazard Analysis: Ensuring risks are mitigated as per established safety protocols.
• Predicate Device Performance: Pass/fail criteria were based on specifications cleared for the predicate devices, ensuring substantial equivalence.

8. The sample size for the training set:

Not applicable. This document describes V&V activities for software modifications to existing patient monitors, not the development or training of an AI algorithm from a dataset.

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

Not applicable, as there is no mention of a training set for an AI algorithm.

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