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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 < Y%, etc.) and the reported numerical performance data from these tests are not provided in this summary document. The summary indicates that "Performance verification was performed in accordance with Edwards' current design requirements," and "shelf-life and sterilization validations have been performed to existing specifications." These are standard engineering and manufacturing performance metrics, not AI/ML performance metrics.

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

The document refers to "Performance verification" and "Biocompatibility testing." These generally involve lab-based testing (e.g., mechanical stress tests, pressure accuracy checks on a test bench, chemical compatibility tests) rather than patient data test sets in the context of an AI/ML algorithm.

• Sample Size for Test Set: Not specified. The nature of the "test set" here refers to physical product samples for engineering verification and manufacturing quality, not a dataset of patient measurements for AI validation.
• Data Provenance: The studies mentioned (biocompatibility, performance verification, shelf-life, sterilization) are likely conducted in a controlled lab/manufacturing environment, not directly on patient data. Therefore, questions of "country of origin" or "retrospective/prospective" data collection are not applicable in the context of this type of submission.

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

Given this is not an AI/ML submission related to diagnostic imaging or interpretation, the concept of "experts establishing ground truth" in the clinical sense is not applicable. The ground truth for this device's performance would be established through:

• Engineering specifications and testing standards for pressure transducers.
• Biocompatibility standards (e.g., ISO 10993-1).
• Sterilization validation protocols.
• Comparison to the performance of the predicate device.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic interpretations where multiple readers assess cases. This submission is about the physical device's material change and its impact on manufacturing and engineering performance, not clinical interpretation.

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

No. An MRMC study is designed to assess the impact of an AI algorithm on human reader performance for tasks like diagnosis or detection. Since this submission is for material changes to a physical sensor, and there is no AI component described, an MRMC study was not performed and is not relevant.

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

No. This question pertains to AI/ML algorithms. The device described (pressure sensor) does not have a standalone AI algorithm that would produce a diagnostic output. Its function is to convert a physiological signal to an electrical signal for a monitor.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering specifications and validated testing methods: For pressure accuracy, electrical signal output fidelity, and physical integrity.
• International standards (e.g., ISO 10993-1): For biocompatibility.
• Defined shelf-life and sterilization parameters: Within established industry and regulatory norms.
• Comparison to the performance characteristics of the legally marketed predicate devices.

This is not ground truth derived from expert consensus, pathology, or outcomes data in the clinical sense, as it's not a diagnostic AI device.

8. The Sample Size for the Training Set

Not Applicable. Training sets are relevant for machine learning algorithms. This submission does not describe an AI/ML component or the training of such a component.

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

Not Applicable. As there's no mention of an AI/ML training set, the establishment of ground truth for it is irrelevant to this 510(k) summary.

In summary: This FDA 510(k) summary provides a high-level overview of a submission for material changes to existing medical devices (intravascular pressure sensors). The document focuses on demonstrating substantial equivalence by confirming that these material changes do not negatively impact the device's established performance, biocompatibility, shelf-life, or sterilization. It does not contain the detailed information typically associated with the validation of an AI/ML diagnostic algorithm, such as specific performance metrics, test set sizes for clinical data, expert panel ground truth adjudication, or MRMC study results.

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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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Fogarty Venous Thrombectomy Catheters are indicated for use in the peripheral venous vasculature of adult patients for the removal of emboli and thrombi, and may be used for temporary vessel occlusion.

Fogarty venous thrombectomy catheters are specifically designed for the performance of venous thrombectomy in adult patients. Fogarty venous thrombectomy catheters have a long, soft tip which is intended to facilitate advancement past the venous valves while minimizing trauma. The flexibility required for the venous procedure is supplied by the spring-wound body. The spring is covered with a braiding for additional strength. The gate valve is designed for single-handed operation and to minimize the possibility of leakage. The gate valve has an arrow to indicate the "open" and "closed" positions. There are three available catheter sizes (6 French (2.0 mm), 8 French (2.7 mm), and 8/10 French (2.7/3.3 mm)). Each may be quickly identified by the color-coded body. The size and filling capacity are printed on each catheter.

This document is a 510(k) summary for the Fogarty Venous Thrombectomy Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. Importantly, it focuses on demonstrating substantial equivalence to a preamendment predicate device through bench testing, biocompatibility testing, shelf-life, packaging, and sterilization validations. It does not present a study proving the device meets acceptance criteria related to AI/software performance or human-in-the-loop improvements, nor does it discuss ground truth establishment, expert consensus, or MRMC studies.

Therefore, I cannot extract the information required to answer your prompt because the provided text pertains to a traditional medical device (catheter) and does not contain information about AI, software, or the types of studies you are asking about (e.g., MRMC studies, standalone algorithm performance).

The document explicitly states: "Bench testing inclusive of design verification, packaging, sterilization, and biocompatibility testing all demonstrate that the subject devices are substantially equivalent to the predicate devices." This highlights that the device's performance is demonstrated through physical and biological testing, not through AI/software evaluation.

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The Edwards Algorithm for Measurement of Blood Hemoglobin is indicated for continuously monitoring changes to hemoglobin concentration in the circulating blood of adults ≥ 40 kg receiving advanced hemodynamic monitoring using HemoSphere ForeSight Oximeter Cable and non-invasive ForeSight sensors (large) in cerebral locations.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for use as an adjunct monitor of relative and total hemoglobin concentration of blood in individuals at risk for reduced-flow or no-flow ischemic states in surgical and ICU settings.

The Edwards Algorithm for Measurement of Blood Hemoglobin is intended for continuously and non-invasively monitoring the relative and total hemoglobin values in the blood of patients requiring advanced hemodynamic monitoring in a critical care environment. The outputs of the algorithm include the relative changes in total hemoglobin in blood ( $\Delta$ tHb) and total hemoglobin in blood (tHb) parameters and are derived from the relative change in concentration of total tissue hemoglobin ( $\Delta$ ctHb parameter) measured by the ForeSight Oximeter Cable on the HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022).

The subject algorithm provides relative blood hemoglobin ( $\Delta$ tHb; measured in g/dL of blood) values continuously as a change over time from 0 g/dL. It can also be calibrated using an optional input of reference blood hemoglobin measurements such as ones obtained in vitro from a blood gas analyzer. When calibrated, it provides the value of total blood hemoglobin (tHb).

Additionally, the algorithm also provides three secondary output flags:
o DoNotCalibrate Flag: This flag is intended to indicate when a calibration should not be performed.
o Recalibrate Flag: This flag is intended to indicate when a new calibration is recommended.
o Unstable Flag: This flag is intended to indicate when the input signal ( $\Delta$ ctHb) is unstable.

The provided text describes the Edwards Algorithm for Measurement of Blood Hemoglobin, an algorithm intended for continuously monitoring changes to hemoglobin concentration. Here's a breakdown of the acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results demonstrated that the subject device subject device met the acceptance criteria of 1g/dL with a bias close to 0 and precision less than 1g/dL". While it mentions meeting the criteria, the exact numerical values for bias and precision are not explicitly provided in the text beyond "close to 0" and "less than 1g/dL". The 1g/dL criteria appears to be for RMSE/ARMS.

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

• Sample Size: 83 patients
• Data Provenance:
  • Country of Origin: Data was collected from 5 sites across the US and EU.
    • Amsterdam, The Netherlands (European Union) - 27 patients (32.53%)
    • Santander, Spain (European Union) - 8 patients (9.64%)
    • Greenville, North Carolina, USA - 18 patients (21.69%)
    • Sacramento, California, USA - 11 patients (13.25%)
    • Chicago, Illinois, USA - 19 patients (22.89%)
  • Retrospective or Prospective: Retrospective analyses were performed on data already collected, independent of the device development.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth. However, it indicates that the device's performance was compared against a "laboratory co-oximeter," which implies a gold standard measurement method rather than expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by laboratory co-oximeter measurements, not through expert adjudication of human interpretations.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the algorithm's direct performance against a laboratory co-oximeter. The text states, "No clinical trial was performed in support of the subject 510(k) submission."

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

Yes, a standalone performance study was done. The performance data was assessed by comparing the device's output to laboratory co-oximeter measurements, without human interaction with the algorithm's output during the measurement process. The algorithm's outputs are numerical values for hemoglobin concentration.

7. The Type of Ground Truth Used

The ground truth used was laboratory co-oximeter measurements of total hemoglobin values in blood. This is considered a highly accurate and objective reference method for hemoglobin quantification.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. The descriptions provided are solely for the retrospective analysis performed for validation (the test set).

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

The document does not provide information regarding how the ground truth for the training set was established, as details about the training phase are not included in the provided text.

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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 < 65 mmHg for at least one minute in duration) 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.

When used in combination with the HemoSphere Pressure Cable 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.

Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Alta 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 <8 kg and non-cerebral use on pediatric subjects <5kg.

Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Alta Monitor with ClearSight Technology

The HemoSphere Alta when used with the pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult.

The HemoSphere Alta monitor and compatible Edwards finger cuffs non-invasively measures blood pressure and associated hemodynamic parameters. Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

The Edwards Acumen Hypotension Index (HP)) feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) 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 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 Alta 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 HemoSphere Alta Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.

The HemoSphere Alta Advanced Monitoring Platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPTs, ForeSight /ForeSight Jr sensors, and ClearSight/Acumen IQ finger cuffs.

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 Acumen™ IQ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the HemoSphere advanced monitoring platform.

The Acumen IQ finger cuff is intended to noninvasively measure blood pressure and use the information to derive hemodynamic parameters when connected to an Edwards' HemoSphere Advanced Monitoring platform.

The provided text describes a 510(k) premarket notification for the Acumen IQ finger cuff, which is a modified version of a previously cleared device (K190130). The modification involves expanding the finger circumference size range and removing a finger sizing aid. The submission states that the device is identical to the predicate device in terms of design, intended use, and technology.

The document mentions that usability testing was conducted in accordance with ANSI/AAMI HE75 and that clinical performance testing was completed to ensure the finger cuffs perform as intended, and that the Acumen IQ finger cuff has successfully passed all testing. However, the actual acceptance criteria and device performance results from these studies are not explicitly provided in the given text. The text only broadly states that the device "successfully passed all testing."

Without the specific details of the clinical performance testing, a comprehensive table of acceptance criteria and reported device performance cannot be generated. Similarly, concrete information regarding sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone performance is not available in the provided document.

Therefore,Based on the provided text, a complete answer to your request is not possible. The document states that clinical performance testing was completed and successfully passed, but it does not provide the specific acceptance criteria or the numerical results of this performance testing.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and the Reported Device Performance: This information is not provided in the document. The text only states that "clinical performance testing was completed to ensure the finger cuffs perform as intended" and that the device "has successfully passed all testing." No specific criteria (e.g., accuracy, precision) or numerical performance values are given.

2. Sample size used for the test set and the data provenance: This information is not provided in the document.

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 in the document.

4. Adjudication method for the test set: This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided in the document. The device is a "noninvasive blood pressure measurement system," not an AI diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is a measurement device. Its "performance" would inherently be standalone in its measurement capability once the cuff is applied. However, specific methodology (e.g., comparison to invasive measurements) and results are not provided.

7. The type of ground truth used: Given that the device non-invasively measures blood pressure, the ground truth for clinical performance testing would typically be established using a reference method for blood pressure measurement, such as invasive arterial line measurements or a highly accurate non-invasive oscillometric device that meets specific standards (e.g., ISO or BHS protocols). However, this is not explicitly stated in the document.

8. The sample size for the training set: This information is not provided in the document. (Note: For a device like a blood pressure monitor, there might not be a "training set" in the same sense as an AI algorithm that learns from data. It's more about calibration and validation against ground truth.)

9. How the ground truth for the training set was established: This information is not provided in the document.

In summary, the provided FDA clearance letter and 510(k) summary confirm that usability and clinical performance testing were conducted and passed, but they do not detail the specific acceptance criteria, performance results, or methodologies of those studies.

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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.

The Smart Wedge algorithm is designed to provide the value at end-expiration of the pulmonary artery occlusion pressure (PAOP) signal, also called pulmonary wedge pressure, pulmonary capillary wedge pressure (PCWP), or pulmonary artery wedge pressure (PAWP), and to assess the quality of the pulmonary artery occlusion pressure measurement.

The Smart Wedge algorithm is intended to be used with a Swan-Ganz pulmonary artery catheter connected to a pressure cable and pressure transducer.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The device performance is reported for two main aspects: PAOP (Pulmonary Artery Occlusion Pressure) Identification and PAOP Measurement. The acceptance criteria can be inferred from the reported performance results and the comparison to the predicate device, especially the statement: "Results for the Smart Wedge algorithm met or exceeded predicate device performance." While explicit numerical acceptance criteria aren't listed as "targets," the provided performance values serve as the acceptable outcomes.

Note: The document explicitly states for PAOP Measurement: "PAOP within mean absolute error < 4 mmHg accuracy." This serves as a clear numerical acceptance criterion for MAE.

2. Sample Sizes and Data Provenance

• Test Set (PAOP Identification): 225 PAP waveforms from 129 patients.
• Test Set (PAOP Measurement): 110 PAOP measurements from 59 patients.
• Data Provenance: Retrospectively collected from ICU and OR patients. The country of origin is not specified, but given the Edwards Lifesciences headquarters in Irvine, California, it's likely primarily US-based or multi-site.

3. Number of Experts and Qualifications

• Number of Experts: Three experienced healthcare providers (HCPs) were used to establish the ground truth.
• Qualifications: Described as "experienced healthcare providers (HCPs)." Specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed, but the term "experienced" suggests domain expertise relevant to pulmonary artery occlusion pressure waveforms.

4. Adjudication Method for the Test Set

• For PAOP Identification: "Mode of three HCP annotations." This means the most frequent annotation among the three experts was
  taken as the ground truth.
• For PAOP Measurement: "Average PAOP measurement of three HCPs." This implies the numerical average of the three experts' measurements was used as the ground truth.

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

• The document explicitly states: "No clinical trial was performed in support of the subject 510(k)."
• Therefore, an MRMC comparative effectiveness study, which typically involves human readers improving with AI vs. without AI assistance, was not conducted. The study focuses on the algorithm's performance against expert consensus.

6. Standalone (Algorithm Only) Performance

• Yes, the reported study describes the standalone performance of the Smart Wedge algorithm. The tables ("Performance Results of PAOP Identification" and "Performance Results of PAOP Measurements") present the algorithm's capabilities (Sensitivity, Specificity, MAE, Bias, Correlation) measured against the established expert consensus ground truth. There's no mention of a human-in-the-loop component in the reported performance metrics.

7. Type of Ground Truth Used

• The ground truth used was expert consensus.
  • For PAOP Identification: "Mode of three HCP annotations."
  • For PAOP Measurement: "Average PAOP measurement of three HCPs."

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set. It mentions the verification was performed using "waveforms retrospectively collected from ICU and OR patients", but the specific number for training versus testing is not provided. The provided numbers (225 waveforms/129 patients for identification, 110 measurements/59 patients for measurement) are for the test set.

9. How Ground Truth for Training Set Was Established

• Similar to the training set sample size, the document does not explicitly detail how the ground truth for the training set was established. Typically, for machine learning models, the training data also requires labeled ground truth, often established similarly to the test set (e.g., expert annotation or other reliable sources). However, this specific 510(k) summary focuses on the verification and validation of the algorithm's performance and the ground truth establishment for the test data.

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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 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.

The Global Hypoperfusion Index (GHI) parameter provides the clinician with physiological insight into a patient's likelihood of a global hypoperfusion event on average 10-15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%. The GHI feature is intended for use in surgical or nonsurgical patients. The product predictions are adjunctive for reference only and no therapeutic decisions should be made based solely on the GHI parameter.

The provided text does not contain detailed acceptance criteria or a comprehensive study report with all the requested information. It primarily presents the FDA's 510(k) clearance letter and a summary of the device, its indications for use, and a comparison to predicate devices, stating that performance testing was executed and that no clinical trial was performed for the 510(k) submission.

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

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

The document mentions that 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 and alerts the clinician on average 10-15 minutes before SvO2 reaches 60%. It also states that the GHI algorithm provides an index from 0 to 100 where the higher the value, the increased likelihood that a global hypoperfusion event will occur.

While specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or AUC) and their corresponding achieved performance values are not explicitly stated in the provided text, the overall conclusion is that the algorithm "has successfully passed functional and performance testing" and "meets the predetermined design and performance specifications." This implies that internal acceptance criteria were met, even if they are not detailed here.

Example (Hypothetical, as not provided in text):

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

• Sample Size: The text states, "Prospective analyses of retrospective clinical data from multiple independent datasets, comprised of data from a diverse set of patients over the age of 18 years undergoing surgical procedures with invasive monitoring, were analyzed to verify the safety and performance of the subject device." However, the exact sample size (number of patients or data points) for the test set is not specified.
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: "Prospective analyses of retrospective clinical data" implies that existing (retrospective) data was collected and then analyzed in a forward-looking (prospective) manner for the purpose of the study.

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

The text does not provide any information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set.

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

The text does not provide any information regarding an adjudication method for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The text explicitly states: "No clinical trial was performed in support of the subject 510(k)." This indicates that an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted for this submission.

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

Yes, a standalone performance evaluation was conducted. The text states:

• "Algorithm performance was tested using clinical data."
• "The algorithm was tested at the algorithm level to ensure the safety of the device. All tests passed."
• "Prospective analyses of retrospective clinical data... were analyzed to verify the safety and performance of the subject device."

This confirms that the algorithm's performance was assessed independently.

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

The ground truth for a "global hypoperfusion event" is explicitly defined in the Indications for Use as: "SvO2 ≤ 60% for at least 1 minute." This is an objective physiological measurement (outcomes data) rather than expert consensus or pathology.

8. The sample size for the training set:

While the text mentions that "patient waveforms were collected in support of the development and validation of the GHI algorithm," the sample size for the training set is not specified.

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

Given that the ground truth for the device's output is based on SvO2 measurements, it is highly probable that the ground truth for the training set was established using the same objective physiological measurement: SvO2 ≤ 60% for at least 1 minute. The text implies that clinical data (patient waveforms) were used for both development and validation.

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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. 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 indications for use statement for information on target patient population specific to the catheter being used. 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 Oximetry Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere 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.
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 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 hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen 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 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 on the HemoSphere advanced monitor.
• When used with large sensor, 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 < 8 kg and non-cerebral use on pediatric subjects <5kg.
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 ClearSight Module:
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
The Edwards Lifesciences Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) 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.
Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

Indications for Use for the Acumen IQ Fluid Meter
The Acumen IQ fluid meter is indicated for surgical patients over 18 years of age to track the fluid being administered to the patient, when used with a compatible hemodynamic monitoring platform.

Intended Use- HemoSphere Advanced Monitoring Platform:
The HemoSphere Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The Viewfinder Remote mobile application can be used for supplemental near real-time remote display of monitored hemodynamic parameter data as well as Faults, Alerts and Notifications generated by the HemoSphere Advanced Monitoring Platform.
The HemoSphere Advanced Monitoring Platform is intended for use with compatible Edwards Swan-Ganz and Oximetry Catheters, FloTrac sensors, Acumen IQ sensors, Acumen IQ fluid meter, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs.

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.
HemoSphere Advanced Monitoring Platform, subject of this submission, consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on the monitor screen and its five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Technology Module (K213682 cleared, June 22, 2022), HemoSphere ForeSight Module (K213682, June 22, 2022), and the HemoSphere ClearSight Module (K203687 cleared, May 28, 2021). Additionally, the HemoSphere Advanced Monitoring Platform includes the Acumen Hypotension Prediction Index software feature (DEN160044 granted March 16, 2018) and the Acumen Assisted Fluid Management software feature (DEN190029 granted November 13, 2020). The HemoSphere Advanced Monitor also has wired and wireless capabilities, which was originally used only for connecting to a Hospital Information System (HIS) for data charting purposes. This capability is now used to allow it to stream continuously monitored data to the Viewfinder Remote, a mobile device-based application, for remote viewing the information (K211465, cleared July 8, 2021). The remotely transmitted data from the patient monitoring sessions include all hemodynamic parameter data and the associated physiological alarm notifications, historical trend data, and parameter waveform data.

HemoSphere Advanced Monitoring platform as cleared in K213682 cleared June 22, 2022, is being modified as follows:

1. Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
   The AFM software feature (AFM algorithm + AFM GUI), which informs clinicians of patient fluid responsiveness (K213682, cleared June 22, 2022), allows for manual fluid tracking, and resides on the HemoSphere Advanced Monitor.
   The AFM software feature is being modified to allow for an automated fluid tracking mode as the default mode. Users can switch to the optional manual fluid tracking mode through the advanced settings menu. This automated fluid tracking mode for the AFM software feature is achieved via two components namely, the Acumen AFM Cable and the Acumen IQ fluid meter (both devices subject of this 510(k)). No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automated fluid tracking mode via the Acumen AFM cable and Acumen IO fluid meter.
   The Acumen AFM Cable is a reusable cable that connects the Acumen IO fluid meter to the HemoSphere Advanced Monitoring Platform and converts the flow rate received from the Acumen IQ fluid meter to total volume for the HemoSphere monitor to be used by AFM software feature. No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automatic fluid tracking mode. The Acumen IQ fluid meter is a sterile, single use device that measures the flow of fluid delivered to a patient through the intravenous line to which it is connected.
   When used together, the Acumen IQ fluid meter with the Acumen AFM Cable connected to a HemoSphere monitor, the fluid volume can be automatically tracked and displayed on the monitor as part of the AFM software feature screens.

2. Automatic Zeroing of the Heart Reference Sensor (HRS)
   The ClearSight Module (CSM), initially cleared in K201446 on October 1, 2020, is a non-invasive monitoring platform that includes a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight/Acumen IQ Finger Cuffs.
   The Pressure Controller (also referred to as 'Wrist unit' or PC2) is connected to the patient via a wrist band. The Pressure Controller connects to the ClearSight Module (CSM) on one end and with the Heart Reference Sensor (HRS) and the finger cuff on the other. The connection to the CSM provides power and serial communication. The Pressure Controller is designed to control the blood pressure measurement process and send the finger arterial pressure waveform to the CSM. The CSM software transforms the finger level blood pressure measurements into the conventional radial blood pressure.
   In the predicate HemoSphere (K213682, cleared on June 22, 2022), as part of the ClearSight workflow, the user was required to zero the HRS prior to monitoring by aligning both ends of the HRS, the heart end and the finger end, and pressing the "0" button on the HemoSphere Graphical User Interface (GUI). After zeroing the HRS, the user is required to place both ends of the HRS in the appropriate location and then they can begin monitoring.
   For the subject device, the Pressure Controller (PC2) firmware has been updated to include a mathematical model that automatically calculates the zero offset of the HRS based on the age of the specific HRS at the time of use. With the addition of the mathematical model, the user is no longer required to zero the HRS prior to start of monitoring since the system now has the zero-offset calculated. As such, the HemoSphere Advanced Monitor graphical user interface (GUI) was updated to remove the Zero HRS step as part of the Zero & Waveform screen and ClearSight setup.
   The ClearSight Module firmware was also updated as part of support for the Automatic Zeroing of HRS feature. The firmware update included additional logging to support HRS calibration, bug fixes and updates to communication to the pressure controller to support display of proper HRS calibration information.

3. Patient Query
   As cleared in K213682, when the user queried for patient information, all patient records that match the search criteria were sent to the HemoSphere platform (from the Viewfinder Hub) for the user to review. With this update, only 30 records are shared at a time between the Viewfinder Hub and HemoSphere monitor.

4. Miscellaneous Updates
   Miscellaneous updates include:

• Bug fixes -
• Cybersecurity updates -
• Operator's manual updates -
• Heart Reference Sensor Instructions for Use update -

Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Edwards Lifesciences, LLC, regarding the HemoSphere Advanced Monitor and related components. It does not contain the detailed acceptance criteria and study proving device performance in the way typically required for AI/ML-driven diagnostic devices. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new clinical claim with a standalone performance study.

Therefore, many of the requested details about acceptance criteria, human expert involvement, ground truth, and training set information are not available in this specific regulatory document, as they are not typically required for a 510(k) submission for device modifications like those described here. The "Acumen Assisted Fluid Management software feature" is mentioned, and an "AFM algorithm" is referenced, but detailed studies on its performance metrics are not included in this summary.

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

Acceptance Criteria and Device Performance Study (Partial Information)

This 510(k) notification describes modifications to an existing device (HemoSphere Advanced Monitoring Platform) and new components (Acumen AFM Cable, Acumen IQ fluid meter). The primary goal is to demonstrate substantial equivalence to a previously cleared predicate device (K213682). As such, the performance data presented is focused on verifying that the modifications do not adversely affect safety and effectiveness, rather than establishing new clinical performance metrics or comparing AI performance against human readers.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria for AI performance in the way one would for a new AI diagnostic claim (e.g., sensitivity, specificity, AUC). Instead, it lists various verification and validation activities performed to ensure the modified device functions as intended and remains safe and effective.

Summary of Performance Data Presented:

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not specified for any quantitative testing that would typically involve a "test set" in the context of AI model validation (e.g., number of patient cases, number of images). The performance data cited are primarily bench simulations and system-level verification, not a clinical study with a patient test set.
• Data Provenance: Not specified, as no new clinical data or specific patient test sets are described. The reference to "bench simulation" suggests data generated in a lab environment.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable/Not Provided: Since "No new clinical testing was performed" for this 510(k), there is no mention of expert involvement for establishing ground truth on a clinical test set. The original AFM algorithm clearance (DEN190029) might contain this information, but it's not in this document.

4. Adjudication Method for Test Set

• Not Applicable/Not Provided: No clinical test set described.

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

• No: The document explicitly states, "No new clinical testing was performed." Therefore, no MRMC study was conducted or reported in this submission.

6. Standalone (Algorithm Only) Performance Study

• Partial/Limited: While the document mentions "AFM outputs when the fluid meter mode was unlocked... were tested using a bench simulation," it does not provide quantitative results (e.g., accuracy, precision) for the algorithm's performance in a standalone setting. The focus is on the functionality and safety of the hardware additions (cable, meter) and the automation of fluid tracking for an existing algorithm. The "core predictive algorithm for the Assisted Fluid Management software feature" is stated to be from the predicate device (K213682), which itself refers back to DEN190029.

7. Type of Ground Truth Used

• Not explicitly stated for AI performance: For the "bench simulation" of AFM outputs, the "ground truth" would likely be the known, controlled fluid flow rates programmed into the simulation. No external clinical ground truth (e.g., pathology, long-term outcomes) is described in relation to the AI/AFM performance in this document.

8. Sample Size for Training Set

• Not Provided: The document focuses on demonstrating substantial equivalence of modifications. Information about the training set size for the AI algorithm (Acumen Assisted Fluid Management software feature) would have been part of its original clearance (DEN190029), not this subsequent 510(k) for modifications and new hardware. It mentions: "No modifications have been made to the previously cleared AFM algorithm."

9. How Ground Truth for Training Set Was Established

• Not Provided: Similar to point 8, this information would pertain to the original clearance of the AFM algorithm (DEN190029) and is not detailed in this document.

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