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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™ Assisted Fluid Management (AFM) Software Feature ("the device") consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (K160552 cleared on June 1, 2016) coupled with an Acumen 10 sensor (which was called FloTrac IO sensor in K152980 cleared on January 19, 2016) connected to a radial arterial catheter. The goal of AFM is to reduce the barriers slowing the utilization of perioperative goal directed therapy (PGDT) during surgical procedures by easing the implementation of PGDT, recognizing patterns of fluid responsiveness (i.e. hemodynamic data and past responses to fluid), and suggesting when fluid administration may improve the patient's hemodynamic state. The clinician is responsible for reviewing the AFM software suggestion in addition to a patient's current hemodynamic state and, if the clinician agrees, the clinician can deliver fluid in the standard-of-care fashion. Alternatively, if the clinician disagrees with the fluid suggestion, it can be rejected as the clinician chooses to not deliver any fluid.

The AFM algorithm can be used on the EV1000 Clinical Platform to help maintain patient fluid balance throughout a surgery. The AFM algorithm continuously estimates patient fluid responsiveness (percent increase in Stroke Volume, A SV%) using current hemodynamic parameters and past responses to fluid boluses. The Acumen AFM software feature is intended to simplify the implementation of fluid management protocols/perioperative goal directed therapy (PGDT).

When an Acumen IO sensor is connected and the AFM algorithm is initialized. the EV1000 Clinical Platform will provide notifications to the user when fluid is recommended by the AFM algorithm. The AFM algorithm learns from the stroke volume response to each fluid bolus to determine if a patient is in a fluid responsive or pre-load dependent state. The patient's tidal volume must be ≥ 8 mL/kg while using the AFM software feature. Throughout the case. the algorithm tracks and records bolus and patient response information to adapt its suggestions based off of the individual patient. In order for the algorithm to analyze each fluid bolus, the start and stop time of each infusion must be entered in the system, as well as the volume of the fluid bolus. The algorithm uses data from the current patient in order to predict their fluid responsiveness; this data is not used by the algorithm to determine fluid responsiveness in future patients.

Each bolus can be administered with the fluid, rate, and volume at the discretion of the clinician. Additionally, any fluid bolus can be declined or discarded as deemed appropriate by the clinician. The AFM algorithm will analyze fluid boluses within the following range: Volume: 100 - 500 mL: Rate: 1 - 10 L / hr.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The primary effectiveness endpoint for the Acumen AFM feature was its ability to predict a patient's fluid responsiveness. The acceptance criterion was based on exceeding a historical performance criterion of 30% fluid responsiveness, derived from the OPTIMISE study.

Table 1: Acceptance Criteria and Reported Device Performance

Other relevant performance data:

• User Boluses (Clinician-initiated boluses outside AFM recommendations): 40.9% [37.4, 44.1] of the time, user-administered boluses resulted in an increase in stroke volume. However, the study explicitly states that "it is not appropriate to compare AFM boluses against user boluses," as the study was not designed for this comparison.

Study Proving Device Meets Acceptance Criteria

The study used to prove the device meets acceptance criteria is the Assisted Fluid Management IDE study (AFM IDE study), identified by ClinicalTrials.gov identifier NCT03469570.

1. Sample Size and Data Provenance:

• Test Set Sample Size:
  • 330 subjects were initially enrolled.
  • 307 subjects were assigned to the per-protocol pivotal cohort and included in the effectiveness evaluation for the primary endpoint.
  • The primary effectiveness endpoint was based on the 54% (165/307) of subjects who received and followed AFM Recommended suggestions.
• Data Provenance: Retrospective and prospective. The AFM IDE study was a prospective, multi-center, single-arm clinical study. Data for comparison (historical control) was from a retrospective sub-analysis of the OPTIMISE trial. The AFM IDE study was conducted at study sites in the United States (US).

2. Number of Experts and Qualifications for Ground Truth (Test Set):

• The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set.
• The ground truth for effectiveness (fluid responsiveness) was determined by measuring the percent increase in stroke volume (SV%) following a bolus and comparing it to the selected fluid strategy threshold (e.g., 15% increase for a 15% strategy). This is a physiological measurement, not directly an expert interpretation of an image or signal. Clinical decisions were made by the clinicians in charge during the study, and their actions (administering fluid after an AFM recommendation) were then assessed for outcomes.

3. Adjudication Method for the Test Set:

• For safety events, a Clinical Events Committee (CEC) reviewed and adjudicated events for anticipation, severity, and relatedness to fluid management.
• For effectiveness, the assessment was based on whether the measured physiological response (stroke volume increase) met the predefined fluid strategy threshold. There is no explicit mention of an adjudication method (like 2+1 or 3+1) for the primary effectiveness endpoint, as it relies on objective physiological measurements monitored by the device.

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

• No, an MRMC comparative effectiveness study was not done in the conventional sense of human readers interpreting data with and without AI assistance to assess diagnostic improvement.
• This device is an "adjunctive open loop fluid therapy recommender," meaning it provides suggestions to clinicians who then make the final decision and administer fluid. The study evaluated the outcome of following the device's recommendations (i.e., did the patient become fluid responsive as predicted?).
• The comparison was against a historical performance criterion (30% fluid responsiveness) rather than a direct comparison of human performance with and without AI assistance in real-time decision-making scenarios where human performance itself is being measured and improved. The text states: "The AFM IDE study was not designed to compare against manually administered fluid management protocols."

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

• The primary effectiveness endpoint was not purely standalone. It evaluated the performance of the device's recommendations followed by clinician action. The outcome measured was the percentage of times an AFM recommendation that was followed by a clinician-accepted and clinician-delivered bolus resulted in the desired physiological change.
• The algorithm generates the recommendations (standalone function), but the ultimate "performance" (i.e., whether the patient responded as predicted by the recommendation) is assessed in the context of it being a decision support tool where the human makes the final decision. The study notes that a "major study limitation" was that decline rates were high for AFM recommendations (~50%), and the outcome for these declined interventions is unknown.

6. Type of Ground Truth Used:

• The ground truth for the effectiveness endpoint was based on physiological outcomes data: specifically, the percent increase in stroke volume (SV%) after a fluid bolus, compared against a pre-selected fluid strategy threshold (e.g., 10%, 15%, 20%). This is an objective, measured physiological response.
• The historical control for comparison was also derived from clinical study data (OPTIMISE trial).

7. Sample Size for the Training Set:

• The document does not explicitly state the sample size for the training set used to develop the AFM algorithm.
• It mentions that "Algorithm unit testing was performed using privately collected patient data."
• "The AFM algorithm learns from the stroke volume response to each fluid bolus to determine if a patient is in a fluid responsive or pre-load dependent state. The algorithm uses data from the current patient in order to predict their fluid responsiveness; this data is not used by the algorithm to determine fluid responsiveness in future patients." This suggests a patient-specific learning component rather than a large, fixed, pre-trained model for all patients.

8. How Ground Truth for Training Set was Established:

• The document describes the algorithm's learning process: "The AFM algorithm learns from the stroke volume response to each fluid bolus to determine if a patient is in a fluid responsive or pre-load dependent state." This implies that the ground truth for training (or rather, for its adaptive learning) is the actual measured physiological response (stroke volume change) of a patient to administered fluid boluses.
• The animal study also provided "non-clinical justification for the basic validity of the AFM algorithm" by showing more fluid suggestions in hypovolemic states compared to hypervolemic states. This could be considered a form of "validation data" or coarse "ground truth" for the algorithm's underlying physiological model, but it's not described as the primary training data.

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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. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below 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 is indicated for use in adult and pediatic critical care patients requiring of yenous oxygen saturation (SvO2 and Scv02) 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 Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 40 kg.
· When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects ≥3 kg.
· When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects

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.
The HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and four optional external modules: the HemoSphere Swan-Ganz Module (existing), the HemoSphere Oximetry Cable (existing), the HemoSphere Pressure Cable (existing) and the HemoSphere Tissue Oximetry Module (subject of this submission). The platform also includes the Acumen Hypotension Prediction Index feature.
The existing optional HemoSphere Swan-Ganz Module and HemoSphere Oximetry Cable provide an interface to connect with currently cleared and commercially available Edwards Lifesciences Swan-Ganz catheters and Oximetry catheters (K803058, K822350, K905458, K924650, K934742, K940795, K053609 and K110167 and K160884).
The HemoSphere Pressure Cable provides an interface to connect with currently cleared and commercially available Edwards Lifesciences FloTrac (K152980), FloTrac IQ (K152980) and TruWave DPT sensors (K142749).
The HemoSphere Pressure Cable also enables the Acumen Hypotension Prediction Index (HPI) feature when connected to an Acumen IQ sensor.
The HemoSphere Tissue Oximetry Module is an interface module intended to be used with the Fore-Sight Elite Tissue Oximeter Module (K180003, cleared May 10, 2018) to display continuous monitoring of blood oxygen saturation in the tissue (StO2).
Additionally, the HemoSphere Advanced Monitoring Platform includes the Fluid Responsiveness Test feature (fluid bolus and passive leg raise).
The HemoSphere Advanced Monitor has an input that can be connected to an external vital sign patient monitor for slaving in an analog ECG and pressure signals. The HemoSphere Platform uses this analog ECG input signal to calculate a heart rate that is used by the HemoSphere Swan-Ganz Module to calculate certain derived parameters (e.g. HRavg, SV, RVEF and EDV).
The HemoSphere Pressure-Out cable enables output of analog pressure signals (AP, CVP or PAP) for display on an external patient monitor.

The provided text is a 510(k) Summary for the "HemoSphere Advanced Monitoring Platform" and its associated modules and features. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing performance through various verification and validation activities.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested (e.g., specific thresholds for accuracy, sensitivity, specificity for the Hypotension Prediction Index or other parameters). Instead, it states that "All tests passed" for various verification activities.

However, based on the description of the testing performed, the implicit acceptance criterion for each test was that the device met its predetermined design and performance specifications.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "bench simulation" for system verification and "bench and simulated environment testing" for wireless coexistence. For the usability study, "32 users" were involved.

• Test Set Sample Size:
  • System Verification: Not explicitly stated beyond "bench simulation."
  • Wireless Coexistence: Not explicitly stated beyond "bench and simulated environment."
  • Usability Study: 32 users.
• Data Provenance: The document does not specify the country of origin for the testing data or whether it was retrospective or prospective. Given the nature of "bench simulation" and "simulated environment," these are inherently prospective tests conducted in a controlled lab setting rather than on patient data from a real clinical setting.

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

The document does not describe the establishment of a ground truth by experts in a clinical context. The testing primarily involved performance verification against design specifications and relevant standards in laboratory settings.

For the usability study, "32 users with a mix of clinicians and nurses" were involved, but their role was in usability testing (evaluating the human-device interface) rather than establishing ground truth for a diagnostic algorithm.

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

No adjudication method is mentioned. This is consistent with the type of testing performed (bench/simulated verification and usability testing) which typically does not involve adjudication of clinical data.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document explicitly states: "Clinical data was not required for this device." Therefore, there is no information on improvement of human readers with or without AI assistance. The Acumen Hypotension Prediction Index (HPI) feature is described as providing "physiological insight" and "additional quantitative information" for reference, with the caveat that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This indicates that it's an informational tool, not a diagnostic aid requiring human-in-the-loop performance evaluation in the described submission.

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

The "Acumen Hypotension Prediction Index feature" is an algorithm. While its standalone performance is not detailed with specific metrics (e.g., accuracy, sensitivity, specificity of hypotension prediction), its inclusion as part of the overall system verification implies that its computational function was tested. The statement "Verification and validation testing was performed to compare the performance and functionality of the HemoSphere Advanced Monitoring Platform to its predicate devices. Testing included a side-by-side comparison of the output parameters using a bench test" suggests that the HPI's output, like other parameters, was verified against expected values or predicate device outputs in a simulated environment. However, specific performance metrics for the HPI algorithm itself are not provided in this summary.

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

The document does not detail the use of expert consensus, pathology, or outcomes data to establish ground truth.

• For system verification, the implied ground truth would be the device's own predetermined design and performance specifications, likely established through engineering and scientific principles. "Bench simulation" typically involves comparing device outputs to known inputs or established reference values.
• For electrical safety, EMC, wireless coexistence, and software verification, the ground truth is defined by the compliance requirements of the cited industry and FDA standards (e.g., IEC 60601 series, FDA Guidance for software).
• For the usability study, the "ground truth" equates to the successful completion of tasks by users, and compliance with usability engineering principles, rather than a clinical truth.

8. The sample size for the training set

The document describes verification and validation activities conducted on the device, but it does not mention a training set sample size. This is consistent with the type of submission which focuses on substantial equivalence for hardware, integrated software functions, and an analytical feature (HPI) where the underlying algorithms might have been developed and "trained" prior to this specific submission, and this submission focuses on their integration and verification in the new platform. If the HPI algorithm itself had undergone a new, extensive development and training phase relevant to this submission, more details would typically be provided.

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

Since no training set is mentioned, there is no information on how its ground truth was established. For algorithms like HPI, ground truth during development would typically involve physiological data labeled with actual hypotensive events from a large pool of patients, but this information is not part of this 510(k) summary.

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

The Acumen Hypotension Prediction Index Feature (DEN160044) consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (DEN160044) and HemoSphere Advanced Monitoring Platform (K180881) paired with the FloTrac IQ or Acumen IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The software includes the Acumen Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eadyn), the Systolic Slope Parameter (dP/dt), and additional graphical user interface features. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure

Here's a breakdown of the acceptance criteria and study information for the Acumen Hypotension Prediction Index based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the overall goal of the device, as described in the Indications for Use and Device Description, is to predict hypotensive events (MAP

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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 of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards is indicated for use in adult and pediative 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 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 feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

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.
The HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and three optional external modules: the HemoSphere Swan-Ganz Module (existing), the HemoSphere Oximetry Cable (existing) and the HemoSphere Pressure Cable (new to the platform). This version of the platform also includes the Acumen Hypotension Prediction Index feature.
The existing optional modules provide an interface to connect with currently cleared and commercially available Edwards Lifesciences Swan-Ganz catheters and Oximetry catheters (K803058, K822350, K905458, K924650, K934742, K940795, K053609 and K110167 and K160884).
The new HemoSphere Pressure Cable provides an interface to connect with currently cleared and commercially available Edwards Lifesciences FloTrac (K152980), FloTrac IQ (K152980) and TruWave DPT sensors (K142749).
All the sub-system modules provide the hardware and software technology to compute hemodynamic monitoring data that is then sent to the HemoSphere Advanced Monitor for visualization and storage.
As cleared under K163381 on April 14, 2017, the HemoSphere Advanced Monitor has an input that can be connected to an external vital sign patient monitor for the purpose of slaving in an analog ECG and pressure signals. The HemoSphere Platform uses this analog ECG input signal to calculate a heart rate that is used by the HemoSphere Swan-Ganz Module to calculate certain derived parameters (e.g. HRavg, SV, RVEF and EDV).
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable (new to the HemoSphere platform) uses the same monitoring technology (pressure and pressure based Cardiac Output), the same computational algorithms and the same default alarm limits as the EV1000A Clinical Platform (K160552, cleared June 1, 2016).
The HemoSphere Pressure Cable also enables the Acumen Hypotension Prediction Index (HPI) feature when connected to a FloTrac IQ sensor similar to the EV1000A Clinical Platform (DEN160044, granted March 16, 2018).
The HemoSphere Pressure Cable when connected to a TruWave DPT sensor and a compatible Edwards Advanced Swan-Ganz catheter allows monitoring of a new parameter; Mean Pulmonary Arterial Pressure (MPAP).
Additionally, a HemoSphere Pressure-Out cable has been developed for the HemoSphere Advanced Monitor. This cable enables output of analog pressure signals (MAP, CVP or PAP) for display on an external patient monitor.

The provided text is a 510(k) summary for the Edwards Lifesciences HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, and Acumen Hypotension Prediction Index feature.

Based on the provided document, here's a breakdown of the acceptance criteria and the study proving the device meets them:

No clinical performance data (multi-reader multi-case study, standalone performance) for the Acumen Hypotension Prediction Index (HPI) feature is provided in this 510(k) summary. The document explicitly states: "Clinical data was not required for this device." The review of the Acumen HPI feature is described as "similar to that granted in DEN160044 on March 2018." Therefore, information regarding acceptance criteria and performance studies for the Acumen HPI feature would likely be found in the DEN160044 submission, not in this document.

The provided document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing (bench and simulated environment testing) for the new or modified components of the HemoSphere Advanced Monitoring Platform, particularly the HemoSphere Pressure Cable and the integration of the Acumen HPI feature (which itself was previously cleared).

Therefore, the following answers are based on the information provided for the HemoSphere system components and the integration of the HPI feature, not the HPI algorithm's performance itself.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission focuses on non-clinical testing for substantial equivalence, the "acceptance criteria" are not detailed as specific performance metrics with target values for accuracy, sensitivity, or specificity in a clinical context. Instead, the acceptance criteria are implicitly that the device performs functionally as intended and meets relevant safety and electromagnetic compatibility (EMC) standards. The "reported device performance" is that all tests passed, demonstrating functional equivalence to predicate devices and adherence to safety standards.

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

• Test Set Sample Size: Not applicable in the context of a clinical test set for AI performance. The testing described is non-clinical (bench and simulated environment).
• Data Provenance: Not applicable for a clinical test set. The data originates from bench testing, simulated environments, and usability studies. No specific country of origin for clinical data is mentioned as none was gathered. The provenance is internal company testing. The studies were non-clinical.

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

• Not applicable for the type of testing described. Ground truth for the non-clinical tests (e.g., pressure measurements, electrical safety) would be established by reference standards, calibrated equipment, or engineering specifications, not by human experts interpreting data.
• For the usability study, "32 users with a mix of clinicians and nurses" were involved. Their qualifications are listed as "clinicians and nurses" but no further detail on their experience level is provided for establishing "ground truth" (as their role was to evaluate usability, not establish a clinical gold standard).

4. Adjudication Method for the Test Set

• Not applicable for the type of testing described (non-clinical verification). Adjudication is typically used in clinical studies where multiple human readers interpret data that may have ambiguity, which is not the case for electrical safety or bench performance verification.

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

• No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical data was not required for this device."

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

• No, a standalone clinical performance study of the Acumen HPI algorithm was not presented in this submission. The submission states that the HPI feature is "similar to that granted in DEN160044 on March 2018." This implies that the standalone performance of the HPI algorithm was evaluated as part of the DEN160044 submission, not this K180881 submission.
• The tests performed were non-clinical, verifying the integration and function of the HPI feature within the new HemoSphere platform, rather than re-evaluating the core HPI algorithm's performance.

7. The Type of Ground Truth Used

• For the non-clinical performance and verification testing:
  • Bench Testing: Ground truth established through calibrated measurement devices, comparison to reference standards, and predetermined design specifications.
  • Electrical Safety/EMC: Defined by international standards (e.g., IEC 60601 series).
  • Software Verification: Defined by software requirements specifications and testing protocols.
  • Usability Study: User feedback against usability goals and metrics.
• For the Acumen HPI feature itself, the previous submission (DEN160044) would have defined its ground truth (e.g., actual hypotensive events observed in clinical data), but this information is not in this document. The current submission relies on the prior clearance.

8. The Sample Size for the Training Set

• Not applicable for this submission. This document describes the 510(k) clearance for a device (HemoSphere monitor and cables) and the integration of a previously cleared feature (Acumen HPI). It does not describe the training or development of the Acumen HPI algorithm itself. Training set information would reside with the data used to develop the Acumen HPI algorithm, likely part of the DEN160044 submission.

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

• Not applicable for this submission, as it does not detail the training set for the Acumen HPI algorithm. This information would be found in the documentation for the original DEN160044 submission for the Acumen HPI feature.

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To be used only for blood withdrawal.

The blood sampling system is indicated for use on patients requiring periodic withdrawal of blood samples from arterial and central line catheters, including peripherally inserted central venous catheters, which are attached to pressure monitoring lines.

The subject Edwards Lifesciences VAMP Optima closed blood sampling system is a sterile, single-use device that provides a safe and convenient method for the withdrawal of blood samples from pressure monitoring lines. The subject device is a needleless, closed blood sampling system designed to reduce infection, needle sticks, and blood waste associated with blood sampling.
The VAMP Optima closed blood sampling system is designed for use with disposable pressure transducers and for connection to central line catheters (inclusive of peripherally inserted central catheters and central venous catheters) and arterial catheters where the system can be flushed clear after sampling. The VAMP Optima closed blood sampling system is used for the drawing and retention of heparinized or non-heparinized blood from the catheter or cannula within the line, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the blood or mixed heparin and blood

This is a 510(k) premarket notification for the Edwards Lifesciences VAMP Optima closed blood sampling system. It is a new version of an existing device, and the submission aims to demonstrate substantial equivalence to the predicate device (VAMP Plus Venous/Arterial Blood Management Protection System, K161962).

The document does not contain acceptance criteria or a study that directly proves the device meets specific performance acceptance criteria in the traditional sense of a clinical trial for diagnostic performance metrics. Instead, this 510(k) submission focuses on demonstrating substantial equivalence through a comparison to a predicate device and extensive functional and safety testing.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, the document does not present a table of specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding reported performance. Instead, it describes a series of functional and safety tests performed to ensure the device performs as intended and is safe.

2. Sample Size for the Test Set and Data Provenance

The document describes "functional and performance testing," "pre-clinical testing," and "bench studies." These are not clinical studies with "test sets" in the diagnostic performance sense. Therefore, information about patient sample sizes, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided here. These tests would involve laboratory or simulated environments.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The assessments are based on engineering, material science, and safety testing standards rather than expert clinical interpretation of data from a patient test set.

4. Adjudication Method

Not applicable, as there isn't a complex diagnostic outcome requiring adjudication by experts.

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

Not applicable. This device is a blood sampling system, not an AI or imaging diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance. The submission focuses on functional and safety equivalence.

6. Standalone Performance

The functional and safety tests described are effectively standalone performance assessments of the device's ability to maintain sterility, integrity, and perform its intended function of blood sampling and management. However, this is not a diagnostic algorithm standalone performance. The device is designed to be used with human operators in a clinical setting.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established by:

• Engineering specifications and regulatory standards: The device must meet predefined specifications for material strength, leak integrity, flow rates, chemical compatibility, sterilization efficacy, etc.
• Biocompatibility standards: As per ISO 10993-1, to ensure the device does not cause adverse biological reactions.
• Safety standards: Ensuring the device prevents needle sticks, minimizes blood waste, and maintains a closed system.

There is no "expert consensus," "pathology," or "outcomes data" in the context of evaluating diagnostic accuracy for this type of device.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that undergoes "training." The design and manufacturing processes are validated, not "trained."

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

Not applicable, as there is no training set for this type of medical device.

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

The Acumen Hypotension Prediction Index Feature ("the device") consists of software running on the Edwards Lifesciences EV1000 Platform (previously cleared under K100709, K110597, K131892. K140312, and K160552) paired with the FloTrac IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The device includes the Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eagyn), the Left Ventricular Contractility Parameter (dP/dt), and additional graphical user interface features.

HPI is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for sensitivity, specificity, and AUC. However, the reported performance metrics from the clinical validation studies demonstrate a level of accuracy deemed acceptable by the FDA for de novo classification. The high specificities and AUC values, along with the detailed performance table for different HPI ranges, suggest that the device's ability to predict hypotension within the 15-minute timeframe was considered sufficient. The acceptance criteria for usability testing (at least 80% of participants agree or strongly agree) are explicitly stated in the Usability Testing section.

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

The "test set" for the HPI algorithm's performance evaluation was derived from two retrospective patient databases:

• First Database (Edwards Lifesciences):
  • Sample Size: 52 subjects (OR patients)
  • Data Provenance: Global clinical sites, collected via prospective, IRB/EC approved clinical protocols with informed consent for each patient. (Retrospective analysis of prospectively collected data).
• Second Database (University Hospital):
  • Sample Size: 204 subjects (OR patients)
  • Data Provenance: From a university hospital, includes OR patients. (Retrospective analysis of an arterial waveform database).

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

The document does not specify the "number of experts" or their "qualifications" used to establish the ground truth for the test set.

Instead, the ground truth for hypotensive events was defined objectively: "mean arterial pressure (MAP)

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