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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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• HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter and Swan-Ganz Jr catheter indications for use statements for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, FloTrac Jr sensor, Acumen IQ sensor, and TruWave disposable pressure transducer indications for use statements for information on target patient populations specific to the sensor/transducer being used. The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

• HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients >=18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions. The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.

• HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable: The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

  • When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >=40 kg.
  • When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >=3 kg.
  • When used with small sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects

The HemoSphere Advanced Monitor was designed to simplify the customer experience by providing one platform with modular solutions for all hemodynamic monitoring needs. The user can choose from available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

The provided FDA 510(k) clearance letter and summary for the Edwards Lifesciences HemoSphere Advanced Monitor (HEM1) and associated components outlines the device's indications for use and the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed acceptance criteria or the specific study results (performance data) in the format typically required to answer your request fully, especially for acceptance criteria and performance of an AI/algorithm-based feature like the Hypotension Prediction Index (HPI) or Assisted Fluid Management (AFM).

The document states:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation. Additionally, system integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing was conducted, and documentation was provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed."

This indicates that internal performance specifications were met, but the specific metrics, thresholds, and study designs for achieving those specifications are not detailed in this public summary.

Therefore, I cannot populate the table with specific numerical performance data against acceptance criteria for the HPI or AFM features, nor can I provide details on sample size, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The text primarily focuses on:

• Substantial equivalence to predicate devices.
• Indications for Use for various HemoSphere configurations and modules.
• Description of software and hardware modifications (e.g., integration of HPI algorithm, new finger cuffs).
• General categories of testing performed (Usability, System Verification, Electrical Safety/EMC, Software Verification) with a blanket statement that "All tests passed."

Based on the provided document, here's what can and cannot be stated:

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

Cannot be provided with specific numerical data or thresholds from the given text. The document only states that "all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." No specific acceptance criteria values (e.g., "Accuracy > X%", "Sensitivity > Y%", "Mean Absolute Error

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The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team.

The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.

The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team.

iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.

The provided text is a 510(k) Summary for the iCare App, focusing on its substantial equivalence to a predicate device. It primarily details regulatory information, device description, and non-clinical test summaries. It does not contain information about a study that proves the device meets specific performance acceptance criteria for a medical diagnostic or screening function.

The iCare App is classified as a "Medical Device Data System" (MDDS) that transmits, displays, and stores data from connected medical devices. Its function is to aid users and healthcare professionals in viewing test results for health management. It explicitly states: "Both devices make no interpretation, evaluation, medical judgments, or recommendations for treatment." This means the app itself doesn't perform diagnostic functions that would require specific performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested criteria, such as acceptance criteria for diagnostic performance, a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not provided in this document because the device is a data management system, not a diagnostic algorithm.

Here's a breakdown of the applicable information based on the provided text:

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

The document does not present a table of quantitative performance acceptance criteria for diagnostic accuracy, sensitivity, or specificity, because the iCare App is an MDDS for data management, not a diagnostic tool. Instead, acceptance criteria are implied through the successful completion of non-clinical tests that demonstrate the basic functionality, safety, and effectiveness for its intended use as a data display and storage system.

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

• Sample Size for Test Set: Not applicable for diagnostic performance as the device is not a diagnostic algorithm. The document mentions non-clinical testing (software, wireless, cybersecurity, usability) but does not specify "test set" sizes in the context of clinical data for diagnostic performance.
• Data Provenance: Not applicable in the context of clinical diagnostic data. The document focuses on the technical aspects of the software.

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

• Number of Experts: Not applicable, as the device does not perform diagnostic interpretations requiring expert-established ground truth for clinical cases.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable, as there is no clinical test set requiring ground truth adjudication for diagnostic performance.

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

• MRMC Study: No, an MRMC study was not done. The iCare App is an MDDS and does not involve AI assistance for human readers in a diagnostic capacity. It makes "no interpretation, evaluation, medical judgments, or recommendations for treatment."
• Effect Size: Not applicable.

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

• Standalone Performance: No, a standalone performance study in the context of diagnostic accuracy was not done. The device's function is data transmission, display, and storage, not diagnostic algorithm performance.

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

• Type of Ground Truth: Not applicable for clinical diagnostic performance. For the software verification and validation, the "ground truth" would be the successful execution against specified requirements and accepted software engineering practices and FDA guidance.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document does not describe a machine learning model that was trained on a dataset. The iCare App is a software application for data management, not an AI/ML algorithm requiring a training set of clinical data for diagnostic purposes.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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HemoSphere Alta™ Advanced Monitor with Swan-Ganz Technology
The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and petical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed in a hospital environment. Refer to the Edwards Swan-Ganz Ir catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

When used in combination with a Swan-Ganz catheter connected to a pressure transducer, the Edwards Lifesciences Smart Wedge algorithm measures and provides pulmonary artery occlusion pressure and assesses the quality of the pulmonary artery occlusion pressurement. The Smart Wedge algorithm is indicated for use in critical care patients over 18 years of age receiving advanced hemodynamic monitoring. The Smart Wedge algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Smart Wedge algorithm parameters.

HemoSphere Alta Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

HemoSphere Alta Advanced Monitor with HemoSphere Pressure Cable or HemoSphere Alta Monitor Pressure Cable
The HemoSphere Alta monitor when used with the HemoSphere Pressure Cable or HemoSphere Alta monitor Pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, FloTrac Jr, Acumen IQ, and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.

The Edwards Lifesciences Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

When used in combination with the Swan-Ganz technology connected to a compatible Swan-Ganz catheter, the Edward Lifesciences Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Right Ventricular Pressure (RVP) parameters.

When used in combination with the HemoSphere Pressure Cable connected to a compatible Swan-Ganz catheter, the Right Ventricular Cardiac Output (RVCO) feature provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVCO algorithm is intended for use in surgical patients over 18 years of age that require advanced hemodynamic monitoring. The Right Ventricular Cardiac a continuous cardiac output and derived parameters.

The Cerebral Adaptive Index (CAI) Algorithm is an informational index to help assess the level of coherence or lack thereof between Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in patient's cerebral tissue. MAP is acquired by the HemoSphere pressure cable or HemoSphere Alta Pressure Cable and StO2 is acquired by the ForeSight oximeter cable. CAI is intended for use in patients over 18 years of age receiving advanced hemodynamic monitoring. CAI is not indicated to be used for treatment of any disease or condition and no therapeutic decisions should be made based solely on the Cerebral Adaptive Index (CAI) Algorithm.

HemoSphere Alta Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor
The Acumen assisted fluid management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy.

Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the assisted fluid management suggestions.

Acumen IQ Fluid Meter
The Acumen IQ fluid meter is a sterile single use device that is intended to be used with the HemoSphere Alta AFM cable and AFM software feature to inform the user of the rate of flow. The device is intended to be used by qualified personnel or clinicians in a clinical setting for up to 24 hours.

HemoSphere Alta Advanced Monitor with ForeSight Oximeter Cable
The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The ForeSight oximeter cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight oximeter cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere Alta monitor.

• When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents ≥40 kg.
· When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
· When used with Small Sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects

The HemoSphere Alta Advanced Monitoring Platform is Edwards' next-generation platform that provides a means to interact with and visualize hemodynamic and volumetric data on a screen. It incorporates a comprehensive view of patient hemodynamic parameters with an intuitive and easy user interface. The HemoSphere Alta Advanced Monitoring Platform is designed to provide monitoring of cardiac flow with various core technologies coupled with other technologies-based features such as Algorithms and Interactions. It integrates Edwards existing Critical Care technologies into a unified platform.

The Right Ventricular Cardiac Output (RVCO) feature is a machinelearning algorithm that calculates and displays continuous cardiac output (CORV) from the right ventricle using as inputs the right ventricular pressure waveform and derived right ventricular pressure parameters such as SYSRVF, DIARVP, MRVP, RVEDP, PRRV and Max RV dP/dt from the existing Right Ventricular Pressure (RVP) algorithm and if available, intermittent cardiac output (iCO).

The provided text describes the HemoSphere Alta Advanced Monitoring Platform and its various features, as well as the testing conducted to support its 510(k) clearance. However, it does not contain specific acceptance criteria and detailed device performance data in the format of a table, nor does it provide a detailed study that proves the device meets specific acceptance criteria for any of its algorithms.

The document makes general statements about testing, such as:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation."
• "All tests passed."
• "Software verification testing were conducted, and documentation was provided per FDA's Guidance..." "All tests passed."
• "Usability study was conducted per FDA's guidance document... The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm."

While it mentions the Right Ventricular Cardiac Output (RVCO) algorithm as a new algorithm and states that "clinical data (waveforms) were collected in support of the design and validation of the RVCO algorithm," it does not present the detailed results of this validation study, nor does it define specific acceptance criteria for the RVCO algorithm and its performance against those criteria.

Therefore,Based on the provided text, I cannot provide the requested information in the form of a table of acceptance criteria and reported device performance for any specific algorithm, nor can I describe a detailed study that proves the device meets these criteria. The document contains general statements about testing and compliance but lacks the specific quantitative data and study design details needed to answer all aspects of your request.

To provide a complete answer, specific study reports and performance data would be required, which are not present in the provided FDA 510(k) summary.

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The RespArray™ patient monitor is intended to be used for monitoring, storing, reviewing 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 hospital environments. The monitor is for prescription use only.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2).

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The SpO2 (Nellcor™) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion and no motion conditions, and in patients who are well or poorly perfused.

The Microstream™ capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR). The monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. A/hr and ODI are intended for ages 22 and up.

The monitors are not intended for MRI environments.

The RespArray patient monitor (hereinafter called RespArray) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

The provided text is a 510(k) summary for the Edan Instruments Patient Monitor (RespArray). It focuses on establishing substantial equivalence to a predicate device, primarily through non-clinical performance and software verification/validation.

Crucially, the document explicitly states: "Clinical data: Not applicable." This means there was no clinical study conducted to prove the device meets specific acceptance criteria in a human-use setting, particularly relating to diagnostic accuracy where AI assistance or expert consensus would be relevant.

Therefore, many of the requested items, such as multi-reader multi-case studies, ground truth establishment for a test set, and sample sizes for clinical test sets, are not applicable to this submission as per the document's contents.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria discussed are primarily related to electrical safety, electromagnetic compatibility (EMC), and general performance of the physiological parameter measurements (ECG, RESP, NIBP, TEMP, SpO2, CO2). The document states that the device was found to comply with relevant standards and that bench testing shows it meets its accuracy specification and relevant consensus standards.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-clinical data" including:

• Electrical safety and electromagnetic compatibility (EMC) assessments.
• Performance testing-Bench
• Software Verification and Validation Testing.

Detailed Information on the Study:

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

   • Sample Size: Not explicitly quantified in terms of number of patients or physiological measurements. The testing was "bench" testing, meaning laboratory-based tests on the device's functionality and accuracy against reference standards, rather than patient-derived data.
   • Data Provenance: Not applicable in the context of clinical data. For testing against standards, it implies standardized test setups and simulated physiological signals/conditions.

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

   • Not applicable. No experts were used for ground truth establishment as it was non-clinical bench testing against established engineering and medical device performance standards. There's no "ground truth" of a diagnostic nature being established by human experts in this context.

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

   • Not applicable. Adjudication is relevant for human-interpreted diagnostic data. This study relies on objective measurements against engineering specifications and international standards.

4. 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, not applicable. The device is a patient monitor, not an AI-assisted diagnostic tool that interprets medical images/signals for improved human reader performance. The submission explicitly states "Clinical data: Not applicable."

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

   • Yes, in essence. The "Performance testing-Bench" and "Software Verification and Validation Testing" evaluate the device's inherent algorithms and functionality in a standalone manner (without a human in the loop for diagnostic interpretation, but rather for operational functionality and accuracy of physiological measurements). However, this is not in the context of a diagnostic AI algorithm.

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

   • Reference standards and engineering specifications. The "ground truth" for the non-clinical tests is derived from established international and national standards for medical electrical equipment, specific performance criteria for various physiological measurement modules, and the device's own accuracy specifications validated through bench testing.

7. The sample size for the training set:

   • Not applicable for a clinical training set. This is not an AI/ML device in the sense of learning from a large dataset of patient cases. The device's algorithms are designed and verified, not "trained" on patient data in a machine learning sense.

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

   • Not applicable. As above, no clinical training set or associated ground truth establishment process is described or relevant for this type of device submission.

In summary, the provided 510(k) focuses on demonstrating substantial equivalence through adherence to recognized performance and safety standards via non-clinical bench testing and software validation, rather than clinical studies involving human patients or complex AI diagnostic algorithms requiring expert review and adjudication.

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The SimpleSense Platform is intended for use at home, a healthcare facility, or medical research organization under the direction of a licensed medical professional to record, display, and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; d) Activity including posture; e) Systolic and Diastolic Blood Pressure and f) other validated data sources. The SimpleSense Platform is intended for use when the licensed medical professional decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSense Platform is intended to be used by patients at rest with a stationary torso. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances.

The SimpleSense Platform does not produce alarms and is not intended for active patient monitoring. The SimpleSense Platform is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The SimpleSense Platform is not intended for use in the presence of a pacemaker.

The SimpleSense-BP software application is intended to estimate, display and store blood pressure data on adult patients who are twenty two (22) years and older. The SimpleSense-BP can be used after a clinician determines the user's hypertension classification via an auscultatory blood pressure cuff measurement. The Blood Pressure algorithm uses patient specific information (age, gender, height and weight) and the blood pressure measurement as inputs. SimpleSense-BP is used to provide blood pressure estimations derived from physiological sensors to qualified medical personnel as a complimentary physiological feature for the purposes of assessing a patient's cardiac health and variance.

The SimpleSense-BP Software Application accesses the physiological parameters like ECG, heart sounds, and thoracic impedance captured by the SimpleSense Device for processing into the vital sign outputs of the product which includes estimation of Systolic and Diastolic blood pressure. The software uses recorded data from the SimpleSense electronics module as inputs into a validated computational model for estimating blood pressure over the period of wear. The system samples blood pressure while the user is at rest. In addition, SimpleSense-BP Software utilizes inputs such as demographic information (age, weight, height, and gender) and a blood pressure measurement for clinical stratification to the algorithm. The blood pressure outputs are returned to the SimpleSense Mobile Application and/or SimpleSense webserver for display, review and interpretation by a physician.

The Nanowear SimpleSense system is a non-invasive, wearable, and portable medical device for the evaluation and monitoring of patients. It utilizes physiologic and biometric sensors embedded in a garment and an electronics module to gather the heart health data. The specific physiological parameters recorded by the device include: two vectors of Electrocardiogram (ECG), respiratory rate though thoracic impedance, heart sounds, and activity including posture. The signals are recorded by the electronics module on a removable data storage card and are periodically transferred to a smartphone mobile application that connects to the electronics module over a wireless Bluetooth connection. The mobile application provides the functionality of transferring the data collected by the electronics module then relaying the data to the Nanowear web server for display of the data by a physician.

The provided text describes the acceptance criteria and study proving the performance of the SimpleSense-BP software application for blood pressure estimation.

Here's an organized breakdown of the requested information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SimpleSense-BP algorithm are based on the ISO 81060-2 standard for non-invasive sphygmomanometers. The reported performance refers to the accuracy of the device's blood pressure estimations compared to reference measurements.

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

• Sample Size for Induced Change Test: 149 subjects in total were identified, with 147 subjects having usable data. The study ensured at least 10 subjects had a change in BP of at least 15 mmHg systolic or 10 mmHg diastolic for each of the 4 models used by the device.
• Sample Size for Accuracy over Calibration Period Test: 91 subjects. The study enrolled subjects until at least 85 subjects were included and at least 21 subjects in each clinical stratification (Normal, Prehypertension, Stage 1 hypertension, and Stage 2 hypertension) were represented.
• Data Provenance: The document does not explicitly state the country of origin. It indicates that blood pressure variations were induced using physical activity and thermal stimuli, and auscultatory reference measurements were used for validation, suggesting a prospective study design.

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

The document states that "auscultatory reference measurements were used to validate the SimpleSense-BP algorithm." This implies a clinical setting where blood pressure is manually measured by trained personnel, typically healthcare professionals, using a cuff. However, the exact number of experts, their specific qualifications (e.g., "radiologist with 10 years of experience"), or the method of their involvement (e.g., individual readings, consensus) are not specified in the provided text.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1, none) for the test set. The ground truth was established by "auscultatory reference measurements," which usually implies direct clinical measurement rather than adjudicated review of digital data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes a standalone performance study comparing the device's output to a gold standard (auscultatory measurements), not a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no mention of an effect size for human reader improvement with AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes. The entire performance testing section (Section 11) is dedicated to evaluating the "SimpleSense-BP algorithm" against auscultatory reference measurements. This represents a standalone (algorithm only) performance evaluation.

7. The Type of Ground Truth Used

The type of ground truth used is auscultatory blood pressure cuff measurements, which is considered the gold standard for non-invasive blood pressure measurement.

8. The Sample Size for the Training Set

The sample size for the training set is not specified. The document explicitly states, "There was no overlap of subjects between the training and test data sets i.e., none of the measurements from subjects in the training data set were included in the test data set and vice versa," confirming that a training set was used but not detailing its size.

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

The document does not explicitly state how the ground truth for the training set was established. However, given that the validation uses "auscultatory reference measurements" as the gold standard, it is highly probable that the training data's ground truth was established using the same (or a similar and equally robust) method of auscultatory blood pressure measurements.

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The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and pediatic critical care patients requiring of cardiac output (continuous [CO] and intermittent [CO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.

HemoSphere Alta monitor with HemoSphere Oximetry Cable

The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Alta Monitor with HemoSphere Pressure Cable

The HemoSphere Alta monitor when used with the HemoSphere pressure cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.

The Edwards Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

The HemoSphere Alta™ Advanced Monitoring Platform is Edwards' next-Device generation platform that provides a means to interact with and visualize Description: hemodynamic and volumetric data on a screen. The HemoSphere Alta™ Monitoring Platform provides an improved user interface utilizing the existing Edwards technologies and algorithms commercially available in the HemoSphere Advanced Monitoring Platform.

This FDA 510(k) summary for the Edwards Lifesciences HemoSphere Alta Advanced Monitoring Platform (K232294) primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance validation. It explicitly states that "No new clinical testing was performed in support of the subject 510(k)." As such, the document does not provide specific acceptance criteria for AI/algorithm performance or details of a study proving the device meets such criteria through clinical data.

Instead, the submission emphasizes the device's functional and safety aspects, along with the integration of existing, previously cleared technologies and algorithms into a new hardware and software platform with an improved user interface.

Therefore, many of the requested sections below cannot be fully answered based on the provided text, as the focus was on non-clinical verification and substantial equivalence rather than new clinical performance studies for AI/algorithm features.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific acceptance criteria and detailed device performance metrics for individual AI/algorithm features (like HPI, GHI, AFM, RVP) are not detailed as part of a new clinical study for this 510(k) submission. The submission states, "No new clinical testing was performed in support of the subject 510(k)." The "Performance Data" section primarily discusses non-clinical verification.

The document states:

• "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications."
• "Measured and derived parameters were tested using a bench simulation."
• "System integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed."
• "Software verification testing were conducted... All tests passed."

This indicates that internal performance specifications were met, but these specifications themselves are not provided, nor is the performance against them quantified in this public summary.

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

No test set for clinical performance of AI/algorithm features is described, as "No new clinical testing was performed." The device leverages existing, previously cleared algorithms.

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

Not applicable, as no new clinical test set for AI/algorithm performance is described. The AI/algorithm features leverage ground truth established in prior clearances for the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set for AI/algorithm performance is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned, as "No new clinical testing was performed." The submission focuses on the HemoSphere Alta platform being a new generation integrating existing Edwards technologies and algorithms with an improved user interface and hardware.

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

The document does not describe new standalone performance studies for the AI/algorithm features. The AI/algorithm features (HPI, GHI, AFM, RVP) themselves were likely evaluated in standalone fashion during their original predicate clearances (e.g., K231038 for GHI). This 510(k) integrates these existing algorithms into a new platform.

7. Type of Ground Truth Used

The type of ground truth for the AI/algorithm features (HPI, GHI, AFM, RVP) would have been established during their original clearances. For this 510(k) submission, this information is not provided. Typically, hemodynamic algorithms like HPI or GHI rely on physiological measurements (e.g., direct arterial pressure, SvO2 from Swan-Ganz catheter, outcomes data related to hypotension or hypoperfusion events) as ground truth.

8. Sample Size for the Training Set

No details regarding training set sample sizes for the AI/algorithm features are provided in this 510(k) summary, as it covers the integration of existing algorithms. The training data would have been described in the original 510(k) submissions for those predicate algorithms (e.g., for Acumen HPI feature, Global Hypoperfusion Index, Right Ventricular Pressure algorithm, Acumen Assisted Fluid Management).

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

As with the training set size, the method for establishing ground truth for the training set of the AI/algorithm features is not detailed in this 510(k) summary because it pertains to existing algorithms. This would have been covered in their individual predicate 510(k) submissions.

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The SOZO Pro has the following uses:

For adult human patients at risk of lymphedema:

A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.

The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or irradiated.

The SOZO Pro is intended for adult patients living with heart failure.

This device is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.

The SOZO Pro may be used as an adjunct to existing methods by aiding clinicians who are using Subjective Global Assessment (SGA) tools to assess patients at risk of protein-calorie malnutrition (PCM).

The SOZO Pro may be further used to estimate the following body composition parameters in humans to track clinically relevant body composition parameters over time:

• Fat mass

• Fat-free mass

• Total body water

• Intracellular fluid

• Extracellular fluid

• Skeletal muscle mass

• The following outputs are also presented:

• Body Mass Index (BMI)

• Basal metabolic rate (BMR; based on Mifflin St. Jeor's algorithm) displayed in calories per day

• Protein and mineral (also known as 'dry lean mass') represents the content of a body that is not fat or fluid; calculated by subtracting total body water weight from fat-free mass weight.

The SOZO Pro device measures current (I), voltage (V) and phase angle (Phi), and from these values calculates resistance (R), reactance (Xc), and impedance (Z), which are used to estimate the above body composition parameters. The device' software will also display the Cole plot, subject height, weight, age and sex.

The SOZO Pro system consists of a connected hand and footplate with built-in stainless-steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware, and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloud- hosted database. Patient weight is measured with load cells located in the SOZO Pro foot unit or can be hand entered.

Bioimpedance measurements require the patient's weight to be measured by a scale embedded in the base of the system or for the weight of the patient to be entered manually. Following the collection of the patient weight, the patient contacts the SOZO Pro with their bare hands and feet on stainless steel electrodes. The impedance measurement takes about 30 seconds, during which the SOZO Pro® system applies small levels of electrical energy (200μA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.

The provided text describes the SOZO Pro device, a bioimpedance spectroscopy device, and its 510(k) submission to the FDA. However, it does not contain the specific details about acceptance criteria, a comparative study with a human-in-the-loop, the exact sample sizes for test and training sets, the number and qualifications of experts for ground truth, or adjudication methods for all the stated indications for use.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device went through "appropriate testing per design controls to confirm functionality and performance of the indications." While specific numerical acceptance criteria (e.g., accuracy percentages, thresholds) are not explicitly provided in this document, the general categories of testing and the reported outcomes are:

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

• Test Set Sample Size: Not explicitly stated for any of the performance tests. The document mentions "fixed loads" for functional performance, implying a controlled, non-patient-specific test, and "a variety of pacemakers" for compatibility. For the software V&V, it states the software was "verified and validated," which implies testing, but sample size is not quantified.
• Data Provenance: Not explicitly stated. The document is a 510(k) summary for a device manufactured by ImpediMed Limited in Australia. The testing is likely conducted by the manufacturer, but the origin of the data used for performance comparison (e.g., patient data) is not specified. It does not indicate if it was retrospective or prospective.

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

• Not explicitly stated. The document focuses on technical performance and validation against engineering standards and a predicate device, rather than diagnostic accuracy studies involving expert human readers and a ground truth derived from clinical experts.

4. Adjudication Method for the Test Set

• Not applicable/Not explicitly stated. Since there's no mention of a human-in-the-loop diagnostic study or expert consensus for ground truth establishment, adjudication methods are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, not explicitly stated or implied. The submission emphasizes substantial equivalence to a predicate device primarily through technical and functional comparisons, not through a comparative effectiveness study showing improvement in human reader performance with AI assistance. The document states, "The SOZO Pro is intended for use, under the direction of a physician, for the monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data." This indicates it's an aid, not a standalone diagnostic that would typically undergo such a comparative study for its primary clearance.

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

• Yes, implied. The "Functional performance" section, where it states "performance testing was undertaken using fixed loads and comparing modified SOZO Pro to predicate SOZO measurements to demonstrate that outputs remained consistently accurate and precise," suggests standalone performance evaluation. The device measures impedance, resistance, reactance, and then calculates body composition parameters. The validation of these calculations against a known standard (fixed loads, predicate device performance) represents a standalone performance assessment.

7. The Type of Ground Truth Used

• Reference to Predicate Device and Engineering Standards: For most of the performance claims, the ground truth appears to be:

  • The performance of the predicate SOZO device (K203473).
  • Compliance with IEC 60601 (Electrical Safety/EMC), ISO 62304 (Software V&V), ISO 10993 (Biocompatibility), NIST Handbook 44 and EU Directive 2014/31/EU (Weight Scale).
  • Fixed loads for functional performance testing.
  • ISO 14117 for pacemaker/ICD compatibility.

  There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth for the device's diagnostic or monitoring capabilities beyond aiding clinical assessment.

8. The Sample Size for the Training Set

• Not applicable/Not stated. This device does not appear to be an AI/ML device that requires a distinct "training set" in the conventional sense for a deep learning model. It's a bioimpedance spectroscopy device that measures physical parameters and applies algorithms (e.g., Mifflin St. Jeor for BMR). The "software updates were included to integrate the scale and weight measurement capabilities," but this doesn't imply a self-learning algorithm that would require a training dataset.

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

• Not applicable. As it does not appear to be an AI/ML device with a training set, this information is not relevant or provided. The algorithms it uses (e.g., for body composition) are likely fixed formulas validated against general physiological principles and existing scientific literature.

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Swan-Ganz catheters:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
Models 096F6, 096F6P, TS105F5, 132F5, 131F7, 131F7P 831F75, 831F75P, 834F75, and 834F75P are intended for adult and pediatric patients:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of critically ill adult and pediatric patients ≥ 12 years of age including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

FloTrac sensors:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥ 12 years of age.

ClearSight finger cuffs:
The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.
The ClearSight finger cuffs are indicated for adult and pediatric patients ≥ 12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.

HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Pressure Cable (compatible with FloTrac sensors):
The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

Swan-Ganz Catheters:
The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

FloTrac Sensors:
The FloTrac sensor is a sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. When connected to a compatible monitor, the FloTrac sensor minimally-invasively measures cardiac output and key hemodynamic parameters, which assist the clinician in assessing the patient's physiologic status and support clinical decisions related to hemodynamic optimization. The disposable sterile cable, with a red-connector interfaces, exclusively with an Edwards cable that is specifically wired for the pressure monitor being used. The disposable sterile cable, with a green-connector interfaces, exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware.
The FloTrac sensor has a straight, flow-through design across the pressure sensors with an integral flush device.

ClearSight finger cuffs:
The ClearSight finger cuffs, when used with an appropriate Edwards monitoring system, provide continuous, noninvasive hemodynamic monitoring. The ClearSight finger cuffs utilize the volume-clamp method to measure blood pressure with an inflatable bladder wrapped around the middle phalanx of the finger.

HemoSphere Advanced Monitor Platform:
The HemoSphere Advanced Monitoring Platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

This document is a 510(k) summary for Edwards Lifesciences' Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, and HemoSphere Advanced Monitoring Platform. The core of this submission is to expand the indications for use of these devices to include pediatric patients (≥12 years of age), in addition to their existing adult indications.

The information regarding acceptance criteria and the study that proves the device meets those criteria, as detailed in your request, is primarily found in the "Device Verification and Validation" and "Conclusion" sections. However, the FDA summary document only provides a high-level overview. It does not contain the detailed acceptance criteria table, precise performance metrics, sample sizes, ground truth establishment methods, or specific details about expert adjudication or MRMC studies, which are typically found in the full 510(k) submission or supporting clinical trial reports.

Based on the provided text, here's what can be extracted and what information is not present:

Key Takeaway from the FDA 510(k) Summary:

The primary purpose of this 510(k) submission is to expand the indicated patient population for the listed devices from adult-only to include pediatric patients aged 12 years and older. The submission claims that the devices perform similarly in this expanded pediatric population compared to adults, meeting predefined acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

Not Provided in this Document. The document states "within predefined acceptance criteria" but does not list these criteria or the specific reported device performance metrics against them.

Study Details (Based on available information):

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "the target pediatric population in a clinical study" but does not provide the number of patients.
   • Data Provenance:
     • Country of Origin: Not specified in this summary. Clinical studies are often multi-center, but no specific locations are mentioned.
     • Retrospective or Prospective: Not explicitly stated, but the phrase "clinical study" typically implies prospective data collection for regulatory submissions, especially for expanding indications to a new population.

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

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. Given the nature of these hemodynamic devices, ground truth would likely be established by clinical measurements and potentially other validated reference methods, rather than expert interpretation of images or signals in the same way a radiologist might interpret an X-ray. Clinical experts (e.g., intensivists, anesthesiologists, cardiologists) would be involved in patient selection, data collection, and overseeing the study.

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

   • Adjudication Method: Not specified. This type of adjudication (e.g., multi-reader consensus) is more common in image-based diagnostic AI studies. For device performance measurement, agreement with a reference standard is the typical method.

4. 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:

   • MRMC Study: Not applicable/not performed for this type of device and study. MRMC studies are primarily for evaluating AI's impact on human interpretation tasks (e.g., radiologists reading images). This submission is for devices that directly measure physiological parameters and provide data, with one feature (Acumen HPI) providing "physiological insight" for reference. The study focuses on the device's performance in a new patient population, not on how it assists human readers in interpreting complex cases, except perhaps by providing accessible data. The Acumen HPI feature specifically states "no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter," indicating it's an informational tool rather than a definitive diagnostic AI assist requiring a MRMC study.

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

   • Standalone Performance: The study evaluated the devices' performance in the pediatric population. The devices themselves are "standalone" in that they acquire and process physiological signals to output parameters. The statement "The data demonstrate the performance in the expanded pediatric population ≥ 12 years of age and is substantially equivalent to their respective predicate devices for adult patient population ≥ 18 years of age" suggests an evaluation of the device's measurement accuracy and consistency.

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

   • Type of Ground Truth: Not explicitly stated, but for hemodynamic monitoring devices, ground truth is typically established by:
     • Reference Standards/Comparative Measurements: Comparing the device's measurements (e.g., cardiac output, blood pressure) against established, precise, and often more invasive or gold-standard methods (e.g., thermodilution, invasive arterial line measurements from validated transducers).
     • Clinical Outcomes/Safety Data: Demonstrating safety and effectiveness in the target population through clinical monitoring and observation.
   • The document states "clinical data presented in this 510(k) demonstrates the performance of hemodynamic parameters expanded to pediatric patients ≥ 12 years of age... are consistent and within predefined acceptance criteria," implying comparisons to a reference or expected range.

7. The sample size for the training set:

   • Training Set Size: Not applicable/not specified. These devices measure physiological parameters; they are not "AI algorithms" in the sense of needing a large training dataset to learn patterns for classification or prediction (except for the Acumen HPI feature, but no details on its development or training are provided here). The focus of this 510(k) is the application of existing technology to a new age group, not the development of a new pattern-recognition algorithm.

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

   • Ground Truth for Training Set: Not applicable, as there's no mention of a traditional AI training set. The devices likely use established physiological models and algorithms for calculating parameters. If the Acumen HPI feature involved machine learning, its training ground truth would likely be based on recorded physiological data and subsequent hypotensive events. However, the document does not elaborate on the development of this specific feature in the context of this 510(k).

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Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients:

• Bioelectrical Impedance
• ECG Amplitude
• PPG Amplitude
• Skin Temperature

The Zynex Monitoring System, Model CM-1600, simultaneously monitors various parameters of a patient's body. These parameters include Bioelectrical Impedance, Electrocardiogram (ECG) Amplitude, Photoplethysmography (PPG) Amplitude, and Skin Temperature. A Relative Index value is calculated as a combination of the changes in these parameters and is represented by a single number. The CM-1600 System is comprised of two (2) subsystems, the Wearable and the Monitor. The CM-1600 Wearable is designed and developed by Zynex Monitoring Solutions, and it collects physiological parameters and transmits those parameters to the CM-1600 Monitor via wireless communication. The CM-1600 Monitor is a Zynex-branded, third-party all-in-one medical grade tablet.

The provided text is a 510(k) summary for the Zynex Monitoring System, Model CM-1600. It describes the device, its intended use, a comparison to a predicate device, and performance data provided in support of substantial equivalence.

However, the provided document does not contain information regarding an AI/ML device, expert ground truth establishment, or specific details on studies proving the device meets acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, or AUC). The device described, the Zynex Monitoring System, Model CM-1600, monitors physiological parameters such as Bioelectrical Impedance, ECG Amplitude, PPG Amplitude, and Skin Temperature and calculates a "Relative Index" as a combination of changes in these parameters. This appears to be a traditional medical monitoring device, not a device incorporating artificial intelligence or machine learning for diagnostic or interpretive purposes.

Therefore, many of the requested points, such as AI/ML acceptance criteria, sample size for AI/ML test sets, expert adjudication methods, MRMC studies, or ground truth establishment for AI/ML models, cannot be answered from the provided text because the text does not describe an AI/ML device or studies typically associated with its validation.

The available information related to device performance and validation is summarized below:

Device: Zynex Monitoring System, Model CM-1600

Intended Use: Monitoring of Bioelectrical Impedance, ECG Amplitude, PPG Amplitude, and Skin Temperature, and their relative changes in fluid volume in adult patients. It provides numerical values to aid diagnosis by a physician; it is the physician's responsibility to make proper judgments based on these measurements.

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

The document does not specify "acceptance criteria" in terms of numerical performance thresholds (like accuracy percentages or error rates) for the physiological measurements themselves. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device through various performance tests.

Note: The document states "Animal Testing: No Testing Required" and "Clinical Testing: No Testing Required", indicating these were not part of the performance data submitted for this 510(k) clearance.

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 detail specific sample sizes for "test sets" in the way one would for an AI/ML algorithm. The performance testing (V&V/Predicate Testing) demonstrates that the device meets applicable requirements and is substantially equivalent to the predicate device. This typically involves engineering and functional validation, not data-driven performance assessments on patient cohorts for diagnostic accuracy. No information is provided regarding data provenance (country of origin, retrospective/prospective). Since clinical testing was not required/conducted, there isn't patient-specific data being referred to in this context.

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

Not applicable. The document does not describe the establishment of a "ground truth" by experts for diagnostic purposes or for validating an AI/ML model. The device provides raw physiological parameters and a "Relative Index," which are direct measurements or calculations, not interpretations requiring expert consensus for ground truth.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic or interpretive performance.

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, and no MRMC study was mentioned or conducted.

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

Not applicable. The device provides physiological measurements and a calculated index. There isn't an "algorithm only" component that generates a diagnosis or interpretation independent of human interpretation for which standalone performance would be relevant in the context of AI/ML.

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

Not applicable. For this type of physiological monitoring device, "ground truth" would relate to the accuracy of its direct measurements (e.g., how accurately it measures bioelectrical impedance or temperature) against a calibrated standard, not against expert consensus on a diagnosis, pathology, or outcomes data, as these are beyond the scope of a monitoring device providing raw or relative change data.

8. The sample size for the training set

Not applicable. The document does not describe the use of a "training set" for an AI/ML model for this device.

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

Not applicable. As no training set for an AI/ML model is mentioned, the method for establishing its ground truth is not discussed.

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