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The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set (herein referred to as Optima set), model 14000ES16, consists of a sheath, vessel dilator, introducer, and in-sheath dilator. The Optima set is available with inner sheath diameter of 16 French and is used to facilitate introduction and removal of compatible devices used with the Edwards transcatheter heart valve (THV) systems into/from the vasculature.

The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer jacket expands by stretching radially, temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing.

The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.

The 29mm loader (included with the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

The provided text is a 510(k) clearance letter for a medical device called the Edwards eSheath Optima Introducer Set. It outlines the regulatory process and asserts the device's substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that an AI/software device meets those criteria, as typically seen in AI/ML medical device submissions.

The document pertains to a physical medical device (catheter introducer) and its non-clinical performance testing. The "summary of non-clinical testing" section lists various engineering and biocompatibility tests performed on the device itself, not on an AI algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/software device.
2. Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, or how training ground truth was established, because this information is not present in the provided document regarding an AI/software device.

The document is about a physical medical device and its non-clinical (engineering and biocompatibility) testing, not an AI/ML-based device.

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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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Indications for Use: This device is intended for use in patients who are morbidly obese and have failed to lose weight with diet and exercise.

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Here's a breakdown of the acceptance criteria and study details for the Hypertension Prediction Index (HePI) Algorithm, based on the provided FDA 510(k) letter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported performance is for the overall datasets (N=1813 for Minimally Invasive, N=1351 for Non-invasive). All sub-categories (surgical/non-surgical) also met the acceptance criteria.

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

• Minimally Invasive Sensor:
  • US Patients: 1615 subjects
  • OUS Patients: 198 subjects
  • Total N: 1813 subjects
• Non-Invasive Finger Cuff:
  • US Patients: 464 subjects
  • OUS Patients: 887 subjects
  • Total N: 1351 subjects

Data Provenance: The study used retrospective clinical data from multiple independent datasets. Data was collected from both US and OUS (Outside United States) patients.

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

The provided document does not specify the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set

The provided document does not specify an adjudication method. The ground truth definition of a "hypertensive event" is clearly stated (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg), suggesting an objective, pre-defined criterion rather than expert consensus on individual cases that would require adjudication.

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

The provided document does not indicate that an MRMC comparative effectiveness study was done. The focus is on the standalone performance of the algorithm.

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

Yes, a standalone performance study was done. The results presented in Table 2 (AUC, Sensitivity, Specificity, PPV, NPV) are direct measures of the algorithm's performance in predicting hypertensive events based on retrospective clinical data, without human interaction.

7. The Type of Ground Truth Used

The ground truth used is defined by objective physiological measurements and thresholds:
A "hypertensive event" is defined as:

• Mean Arterial Pressure (MAP) greater than 115 mmHg for at least 1 minute OR
• A MAP increase of more than 20% when current MAP is greater than 95 mmHg.

8. The Sample Size for the Training Set

The provided document does not explicitly state the sample size for the training set. It mentions that "Algorithm performance was tested using retrospective clinical data" and "Prospective analyses of retrospective clinical data from multiple independent datasets...were analyzed to verify the safety and performance of the subject device," referring to the test sets.

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

The provided document does not explicitly state how the ground truth for the training set was established. However, given the nature of the device and the ground truth definition for the test set, it is highly likely that the same objective physiological measurements and thresholds (MAP > 115 mmHg for at least 1 minute or MAP increase of > 20% when current MAP > 95 mmHg) were used to establish ground truth labels for the training data.

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The Edwards eSheath Optima introducer set is indicated for the introduction and removal of compatible devices used with Edwards transcatheter heart valves.

The Edwards eSheath Optima introducer set consists of a sheath, vessel dilator, introducer, and insheath dilator. The Edwards Optima introducer set is available with inner sheath diameter of 14 French (model 14000ES14). The Edwards eSheath Optima introducer set is used to facilitate introduction of the Edwards transcatheter heart valve systems into the vasculature.

The sheath shaft is composed of two layers; as devices are passed through the sheath, the inner member expands by sliding against itself while the outer iacket expands by stretching radially. temporarily expanding the shaft diameter. A radiopaque marker on the distal end indicates the location of the sheath tip in the body and a hydrophilic coating on the sheath tubing exterior facilitates introduction into the vessel. The sheath tubing mates with a housing, which holds three seals to provide hemostasis, and an extension tube with stopcock for flushing.

The vessel dilator is used to dilate the vessel prior to sheath insertion. The introducer is inserted into the sheath hub and locked prior to insertion into the body over a guidewire. The in-sheath dilator is used to expand the sheath during device use at the physician's discretion. The introducer, vessel dilator, and in-sheath dilator are radiopaque to improve fluoroscopic visibility intra-procedure.

The loader (included in the Edwards delivery system) features a disc valve within the loader cap assembly to help maintain hemostasis, and a scored perforation on the loader tube allowing the loader tubing to be "peeled away" and removed to utilize the full working length of the inserted device.

The provided document is an FDA 510(k) clearance letter and summary for the Edwards eSheath Optima introducer set. It demonstrates substantial equivalence to a predicate device based on non-clinical testing. However, it does not contain a detailed study meeting the specific criteria you've outlined, particularly for AI/algorithm performance. The information provided relates to the physical and functional performance of a medical device, not an AI or software component.

Therefore, I cannot extract the following information from the provided text:

• 1. A table of acceptance criteria and the reported device performance: While the document mentions various bench tests were "successfully completed" and "all design requirements were met," it does not provide specific quantitative acceptance criteria or detailed numerical results for each test.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as this is non-clinical bench testing of a physical device, not an AI or software study with a test set of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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, as this device does not involve AI or human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable in the context of AI/software performance. For a physical device, the "ground truth" would be the engineering specifications and established test methods.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of available information from the document:

The document describes the Edwards eSheath Optima introducer set, a physical medical device.

Device Description:
The introducer set comprises a sheath, vessel dilator, introducer, and in-sheath dilator. It's designed to facilitate the introduction and removal of compatible devices used with Edwards transcatheter heart valves. Key features include an expandable inner member and outer jacket, a radiopaque marker, a hydrophilic coating, hemostatic seals, and an optional in-sheath dilator.

Non-Clinical Testing:
A list of bench tests was performed to demonstrate substantial equivalence to the predicate device and that all design requirements were met. These tests cover various physical and functional aspects of the device, including:

• Recovered Outer Diameter (OD)
• In-Sheath Dilator (ISD) Max Distal OD
• Tip OD
• ISD Insertion & Retrieval
• Tip Inner Diameter (ID)
• Sheath Insertion & Retrieval
• Sheath Working Length
• ISD Working Length
• Hemostasis
• Kink Radius
• Fishmouth
• Lubricity and Durability
• Bond Tensile Strengths (Sheath Housing to Shaft, Sheath Shaft to Tip, Flush Tube to Housing, Stopcock to Flush Tub, ISD Hub to Shaft)
• Transcatheter Heart Valve (THV)/Sheath Interaction
• Device Interaction
• Guidewire Compatibility
• Delivery System Insertion & Retrieval
• Crimped THV Retrieval
• Radiopacity
• Particulate Testing
• Sterilization Validation
• Biocompatibility (Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility, Thrombogenicity)

The document states that these tests were "successfully completed" and that "all design requirements were met," leading to the conclusion that the device is substantially equivalent to the predicate. However, it does not provide specific acceptance criteria values or the quantitative results from these tests.

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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.

The FloTrac Jr 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 Jr sensor is indicated for use in pediatric patients ≥ 12 years of age.

The Acumen IQ 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.

The VolumeView 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, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.

The provided FDA 510(k) summary for the FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the typical format requested for an AI/ML-based medical device.

This document describes a substantial equivalence determination for extravascular blood pressure transducers (sensors) manufactured by Edwards Lifesciences, LLC. The core of the submission is that the subject devices are identical to the predicate devices in terms of intended use, indications for use, and technological characteristics, EXCEPT for changed pressure tubing and IV set component materials.

Therefore, the "study" described here is primarily focused on demonstrating that these material changes do not introduce new safety or effectiveness concerns, rather than validating an AI/ML algorithm's diagnostic performance against established ground truth.

Here's a breakdown based on the provided text, addressing your questions where possible, and noting where the information is not applicable or not present:

Overview of the Device and Study's Focus:

The devices in question are FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors, which are intravascular pressure monitoring devices that also work with Edwards' arterial pressure-based cardiac output monitoring hardware. The 510(k) submission (K242909) is for modifications to these existing devices, specifically changes to the pressure tubing and IV set component materials. The premise of the submission is that these material changes do not alter the fundamental performance or safety in a way that would require new clinical performance studies typical for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states:

• "All testing met the existing predetermined acceptance criteria."
• "Based on the performance testing and the technological characteristics, the FloTrac sensors, Acumen IQ sensors, and VolumeView sensors meet the established performance criteria and are substantially equivalent to the predicate."

However, the specific quantitative acceptance criteria (e.g., accuracy +/- X mmHg, drift

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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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Cerebral Autoregulation Index (CAI) Algorithm is an informational index intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by 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 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 Autoregulation Index (CAI) Algorithm.

The Cerebral Adaptive Index (CAI) Algorithm is being renamed to Cerebral Autoregulation Index (CAI) Algorithm. The originally cleared Cerebral Adaptive Index is in effect an index of cerebral autoregulation, and the renaming results in a labeling change. The evidence to support the proposed labeling change for the Cerebral Autoregulation Index algorithm demonstrates the capability of CAI to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired, as expressed by the level of coherence or lack thereof between MAP (as a surrogate of cerebral perfusion pressure) and cerebral StO2 (as a surrogate of cerebral blood flow) of the patient.

The Cerebral Autoregulation Index (CAI) Algorithm is a derived parameter that quantifies the dynamic relationship between two existing hemodynamic parameters, Mean Arterial Pressure (MAP) and the Absolute Levels of Blood Oxygenation Saturation (StO2) in the cerebral tissue. CAI is intended to represent a surrogate measurement of whether cerebral autoregulation is likely intact or is likely impaired as expressed by the level of coherence between MAP and cerebral StO2. The output will be represented as an index value in a trend plot.

MAP is acquired from the HemoSphere Pressure Cable (initially cleared in K180881 on November 16, 2018). StO2 used for computing CAI is acquired from the ForeSight Oximeter Cable (cleared in K201446 on October 1, 2020).

CAI will be continuously displayed at 20-second rate. The parameter will not have any alarm ranges and will be represented as a number with a range between 0 to 100. A high CAI value (CAI ≥45) means that MAP and StO2 have a greater coherence and informs the clinician that alterations in MAP may result in concomitant changes in cerebral oxygen saturation because cerebral autoregulation is likely impaired. Whereas a low CAI value (CAI

Here’s a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Cerebral Autoregulation Index (CAI) Algorithm

The document describes a 510(k) submission for a name change (and re-clarification of its meaning) of an existing device (Cerebral Adaptive Index (CAI) Algorithm) to Cerebral Autoregulation Index (CAI) Algorithm. The core algorithm and its function remain the same. The performance data presented appears to be the original validation data for the algorithm, supporting the claim that the renamed device retains its safety and effectiveness.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: 50 subjects.
   • Data Provenance: Retrospectively obtained from 3 clinical sites:
     • Northwestern University, Chicago, USA
     • UC Davis, Sacramento, USA
     • Amsterdam UMC, Amsterdam, The Netherlands
   • Patient Characteristics: Adult surgical patients (cardiac and general surgery) over 18 years of age.

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

   • The document does not specify the number of experts used to establish the ground truth or their qualifications. The ground truth was established algorithmically based on physiological measurements.

3. Adjudication Method:

   • Not applicable/Not mentioned. The ground truth was established via a polynomial fit of CBFV-MAP data to determine LLA and ULA, and then a rule-based classification (Intact or Impaired) was applied. There's no indication of human adjudication of this ground truth.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC study was done, as this algorithm is not intended for human interpretation or direct assistance in a diagnostic image reading scenario. Its output is an index value representing a physiological state.

5. Standalone Performance:

   • Yes, a standalone performance evaluation was conducted. The study assessed the algorithm's ability to discriminate between "Intact" and "Impaired" cerebral autoregulation conditions based on its calculated CAI value, against a ground truth derived from physiological measurements (CBFV-MAP).

6. Type of Ground Truth Used:

   • Physiological Ground Truth: The ground truth for cerebral autoregulation status (Intact vs. Impaired) was established using a polynomial fit of Cerebral Blood Flow Velocity (CBFV) and Mean Arterial Pressure (MAP) data. Specifically, LLA (Lower Limit of Autoregulation) and ULA (Upper Limit of Autoregulation) were determined from this data, and an autoregulation status was assigned based on MAP's relationship to these limits:
     • Impaired: MAP ≤ LLA or MAP ≥ ULA
     • Intact: LLA

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The Fogarty thru-lumen embolectomy catheter is indicated for adults requiring the removal of fresh, soft emboli and thrombi from vessels in the arteries of the peripheral vasculature. Additionally, it may also be used for temporary occlusion of blood vessels, infusion of fluids, and blood sampling in general surgical procedures.

The Fogarty Thru-Lumen Embolectomy Catheter is a double lumen catheter with a latex balloon at the distal end. One lumen is used for balloon inflation and is accessed through the gate valve at the proximal end. The thru-lumen is used for infusion of fluids, sampling of blood or guidewire passage through the distal tip. A removable stainless steel stylet(s) is provided.

It appears there might be a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device: the Fogarty Thru-Lumen Embolectomy Catheter.

This document is not about an AI/software-as-medical-device (SaMD) or a device that relies on complex algorithms requiring a study to prove its performance against acceptance criteria like sensitivity, specificity, or AUC based on a test set, ground truth, or expert readers.

Instead, this device is a physical catheter used to remove emboli and thrombi. The "acceptance criteria" and "study" proving its performance in this context relate to engineering and biocompatibility testing, not to AI model performance or interpretation of medical images.

Here's why the questions about AI/software-related study methodologies are not applicable to the provided document:

• No mention of AI, algorithms, or software: The document describes a physical medical device. There is no indication that it incorporates AI, software, or image analysis to function.
• "Study that proves the device meets the acceptance criteria" refers to bench testing: The document explicitly states under "Device Testing": "Bench testing was performed in accordance with Edwards' current design requirements. In addition, shelf-life, packaging, and sterilization validations have been performed to existing specifications. All testing met the existing predetermined acceptance criteria." This refers to mechanical, material, and sterilization performance, not diagnostic accuracy or AI performance.
• Comparison to a predicate device: The basis for clearance is "substantial equivalence" to a predicate device (Fogarty Thru-Lumen Embolectomy Catheter cleared in K892410). The comparative analysis states, "The subject device is identical to the predicate device in terms of the intended use, indications for use, and technological characteristics (including design, material, chemical composition, principle of operation)." This reinforces that it's a physical device, not an AI system that would typically undergo MRMC studies or performance validation against a ground truth dataset of patient images.

Therefore, I cannot provide the requested information (table of acceptance criteria, sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) because the provided FDA document pertains to a physical medical device and does not involve AI or software development with the type of validation methodology you are asking about.

To summarize, the document is about the FDA clearance of a conventional medical device, not an AI-powered one. The "acceptance criteria" and "study" refer to engineering and biological safety tests, not the performance metrics of an AI model.

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The Edwards Lifesciences 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 AFM Software Feature (core AFM algorithm + AFM Graphical User Interface) was originally granted in De Novo, DEN190029, on November 13, 2020, to inform clinicians about a patient's fluid responsiveness. The performance of the AFM Software Feature in predicting a patient's fluid responsiveness is measured using response rate and is calculated by reporting the percentage of followed AFM recommendations ("Fluid Bolus Suggested" and "Test Bolus Suggested" prompts) that have the desired change in stroke volume (SV), divided by the total number of AFM recommendations.

With this submission, Edwards is seeking clearance for the AFM Prompt Reclassifier algorithm (AFM PR algorithm) to the Acumen AFM Software Feature. The AFM Prompt Reclassifier algorithm is intended to be used in conjunction with the core AFM algorithm to re-assess the fluid bolus recommendations provided by the core alqorithm. It analyzes the patient's current hemodynamics for either confirming (corroborating) the original prompt or reclassifying the prompts (i.e., reclassify a "Test Bolus Suggested" prompt to a "Fluid Bolus Suggested" prompt or vice versa). In doing so, it acts as a secondary check for the fluid bolus prompts such that a greater number of the "Fluid Bolus Suggested" prompts lead to the desired change in stroke volume. Through refined prompt adjustments informed by real-time hemodynamic data, the AFM PR algorithm aims to improve patient responsiveness, thereby optimizing the impact of the AFM Software Feature on patient hemodynamics.

The FDA 510(k) summary for the Acumen Assisted Fluid Management (AFM) Software Feature describes the acceptance criteria and the study conducted to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The algorithm performance was analyzed on an archived dataset consisting of 1229 data points from 307 patients.
• Data Provenance: The data came from the US IDE Study, G170204. The study involved 9 independent U.S. sites. The data is retrospective as it was an "archived dataset."

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

• This information is not provided in the document. The study uses physiological response (change in stroke volume) as the outcome measure, implying a physiological ground truth rather than expert interpretation of images or other data.

4. Adjudication Method for the Test Set

• This information is not provided in the document. Given the nature of the ground truth (physiological response), a traditional adjudication method for subjective assessments might not be directly applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• A MRMC comparative effectiveness study was not explicitly mentioned or described.
• The study focuses on the algorithm's performance in improving the response rate of its suggestions, rather than comparing human reader performance with and without AI assistance. The device offers "suggestions" and the "decision to administer a fluid bolus is made by the clinician."

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

• Yes, a standalone algorithm performance study was done. The document states, "Algorithm performance was analyzed on the archived dataset... The validation was to demonstrate the impact on the response rate of the AFM Software Feature's fluid bolus prompts due to the addition of AFM Prompt Reclassifier algorithm." This implies evaluating the algorithm's predictions against the measured physiological outcomes.

7. The Type of Ground Truth Used

• The ground truth used is physiological response/outcomes data. Specifically, the "desired change in stroke volume (SV)" following AFM recommendations was used to measure the "response rate."

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set. It only mentions the "archived dataset from the US IDE Study, G170204" used for algorithm performance analysis/validation.

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

• The document does not explicitly describe how the ground truth for the training set was established. It focuses on the validation of the AFM Prompt Reclassifier algorithm using an existing dataset. Given that the core AFM algorithm was granted in De Novo DEN190029, the ground truth for its original training would likely have involved similar physiological outcome data from clinical studies where fluid administration decisions were made and subsequent stroke volume changes were observed.

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The Fogarty Fortis Arterial Embolectomy Catheters are indicated for use in adult patients for the removal of fresh, soft emboli and thrombi from vessels in the peripheral arterial system.

The Fogarty Fortis Arterial Embolectomy Catheters provide a means of clearing emboli and thrombi from vessels in the arteries of the peripheral system through inflation of the balloon and engagement with the arterial wall beyond the vascular obstruction followed by gentle withdrawal of the catheter thereby removing the obstruction from its position. The device catheter size is 4F and are available in 40 cm and 80 cm lengths. The device consists of a radiopaque catheter shaft with an integrated elastomeric latex balloon and an atraumatic tip that is inserted surgically into arterial vessels of the peripheral system. A hub at the proximal end is used for balloon inflation.

This document is a 510(k) summary for the Fogarty Fortis Arterial Embolectomy Catheter. It outlines the device description, indications for use, and a comparative analysis to a predicate device. The document states that "All testing met the existing predetermined acceptance criteria." However, it does not provide any specific acceptance criteria or detailed study results for device performance.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and the study proving the device meets them because it is not present in the provided text.

Based on the available information:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document only states, "All testing met the existing predetermined acceptance criteria."
• 2. Sample size used for the test set and the data provenance: This information is not provided. The document mentions "Bench testing was performed in accordance with Edwards' current design requirements," but no details on sample size or data provenance are given.
• 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.
• 4. Adjudication method for the test set: This information is not provided.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a medical device (catheter), not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm, so this concept is not applicable.
• 7. The type of ground truth used: For a physical medical device like an embolectomy catheter, "ground truth" would typically refer to established engineering standards, biocompatibility testing guidelines (e.g., ISO 10993-1), and internal design requirements. The document states:
  • "Biocompatibility testing was performed in accordance with ISO 10993-1: 2018..."
  • "Bench testing was performed in accordance with Edwards' current design requirements."
• 8. The sample size for the training set: This is a physical medical device, not a machine learning model, so there is no "training set."
• 9. How the ground truth for the training set was established: Not applicable, as there is no training set.

The document focuses on substantiating equivalence to a predicate device through bench testing and biocompatibility assessments, stating that the new device meets "existing predetermined acceptance criteria" without detailing what those criteria are or the specific performance metrics achieved.

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