Search Results

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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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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or nonsurgical 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.

The Acumen Hypotension Prediction Index feature consists of software running on the Edwards Lifesciences HemoSphere Advanced Monitoring Platform paired with the Acumen IQ extravascular blood pressure transducer (K152980) and a peripheral arterial catheter. The monitoring system includes the Acumen Hypotension Prediction Index (HPI), and graphical user interface features displaying hemodynamic parameters relevant to assessing the root cause of a potential hypotensive event. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing hemodynamic instability defined as a hypotensive event* within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates a hypotensive event is occurring. The Acumen Hypotension Prediction Index parameter (HPI), should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment. * A hypotensive event is defined as mean arterial pressure (MAP) < 65 mmHg for one minute in duration

Here is the extracted information regarding the acceptance criteria and the study that proves the device meets them:

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

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is titled:
"A Prospective, Single-Arm, Open-Label, Multicenter Study of the Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen Hypotension Prediction Index Feature (HPI Study)."

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

• Test Set (HPI Study):

  • Sample Size: 485 eligible Subjects (460 pivotal with an additional 25 roll-in cases). The Full Analysis Set (FAS) for primary effectiveness included 406 subjects.
  • Data Provenance:
    • Country of Origin: United States (11 study sites).
    • Nature: Prospective, single-arm, unblinded study.

• Comparison Group (Historical Control):

  • Sample Size: 22,109 patients. The population for the primary effectiveness comparison that experienced IOH was 19,445 subjects.
  • Data Provenance:
    • Country of Origin: United States (from hospitals across the United States).
    • Nature: Retrospective historical control group from the Multicenter Perioperative Outcomes Group (MPOG) academic consortium. Dates of data treatment were between January 1, 2017, and December 31, 2017.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth related to the MPOG historical control data or the real-time monitoring data from the HPI Study.

However, the "ground truth" for hypotension (MAP < 65 mmHg for at least one minute) is a directly measurable physiological parameter captured by arterial pressure monitoring, which is a standard of care. The definition of IOH (MAP < 65 mmHg for three or more consecutive 20-second events) is based on established clinical understanding and recorded data rather than expert adjudication of an image or subjective finding.

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

The document does not mention an adjudication method (like 2+1 or 3+1) for establishing the ground truth or evaluating the outcomes in the HPI study. The primary outcome (duration of IOH) and secondary outcomes (AUC, adverse events) were based on directly measured physiological data (MAP) and recorded clinical events, rather than subjective interpretations requiring multiple expert adjudicators. Serious adverse events (SAEs) were "adjudicated," but the specifics of this adjudication process (e.g., number of adjudicators, their roles) are not detailed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated or described as typically understood in the context of image interpretation or diagnostic performance comparison between human readers and AI.

Instead, the study investigated the effectiveness of the Acumen HPI Feature as a decision support tool for clinicians in reducing the duration of IOH. This is a comparative effectiveness study comparing a cohort where clinicians had access to the HPI feature's guidance (HPI Study arm) versus a historical control cohort where clinicians did not have this specific AI-driven predictive guidance (MPOG).

The "effect size" can be considered as the 57.6% reduction in mean IOH duration observed in the HPI arm compared to the MPOG historical control, and a 65% reduction when considering instances with zero IOH episodes. This indicates a significant improvement in patient outcomes (reduced IOH) when clinicians utilize the Acumen HPI Feature for guidance.

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

The document describes the Acumen HPI Feature as a "decision support tool" providing "physiological insight" and "guidance" for clinicians. The primary effectiveness endpoint specifically evaluates the use of the Acumen HPI Feature to guide intraoperative hemodynamic management. This indicates that the study assessed human-in-the-loop performance, where clinicians were receiving and acting upon the device's output. There is no mention of a standalone algorithm-only performance study.

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

The ground truth used for effectiveness endpoints was physiological measures and clinical outcomes data:

• Intraoperative Hypotension (IOH): Defined as Mean Arterial Pressure (MAP) < 65 mmHg for at least one minute (for the general definition) or for three or more consecutive 20-second events (for the study's specific IOH episode definition), which is directly measurable physiological data from arterial pressure monitoring.
• Area Under the Curve (AUC): Calculated from MAP values below 65 mmHg over time.
• Adverse Events/Complications: Such as cardiac arrest, death, stroke, AKI, and MINS, which are clinical outcomes recorded from patient data.

8. The sample size for the training set

The document does not specify the sample size or details of a training set for the Acumen Hypotension Prediction Index feature algorithm. It mentions that the "Acumen Hypotension Prediction Index (HPI parameter) algorithm as implemented on the HemoSphere Advanced Monitoring Platform (K201446, October 1, 2020) is identical to Acumen Hypotension Prediction Index (HPI parameter) algorithm granted in DEN160044." This suggests the algorithm itself was developed and cleared previously, and the current submission focuses on additional clinical data and labeling modifications.

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

Since the document does not provide details of a training set for this specific submission, it also does not describe how the ground truth for any training set might have been established. Based on the nature of the device (predicting hypotension), it is highly likely that any prior training would have used large datasets of continuous arterial pressure waveforms and corresponding MAP values as ground truth for hypotensive events, similar to the definition used in the clinical study.

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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 < 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 Hypotension Prediction Index (HPI) parameter.

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 < 65 mmHg for one minute in duration) within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The Acumen Hypotension Prediction Index, HPI, should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment.

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 < 65 mmHg for at least one minute in duration) within 15 minutes. The Performance Data section states that "Clinical performance data were provided to demonstrate substantial equivalence of use of the Acumen™ Hypotension Prediction Index software."

The core performance attribute is the ability of the HPI to indicate the likelihood of a hypotensive event. The HPI values range from 0 (low likelihood) to 100 (high likelihood). While specific performance metrics like sensitivity, specificity, or AUC are not provided in this excerpt, the study aims to show that the performance in non-surgical patients is substantially equivalent to its established performance in surgical patients (as the predicate device, DEN160044, already had a grant decision).

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

The provided text does not specify the exact sample size for the test set. It only mentions that "Clinical performance data were provided."

Regarding data provenance:

• Country of origin of data: Not explicitly stated.
• Retrospective or prospective: Not explicitly stated.

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

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

4. Adjudication Method for the Test Set

The document does not specify any adjudication method.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus of this 510(k) submission is on expanding the indications for use to non-surgical patients, demonstrating substantial equivalence to the predicate, rather than comparing AI-assisted performance against human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done. The Acumen HPI is described as software that "provides the clinician with physiological insight" and "is considered to be additional quantitative information...for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This implies that the algorithm generates an output (the HPI score) independently, and its clinical performance data (as mentioned under "Performance Data") refers to this standalone algorithm's ability to predict hypotension.

7. Type of Ground Truth Used

The ground truth used for identifying a hypotensive event is clearly defined: mean arterial pressure (MAP) < 65 mmHg for at least one minute in duration. This is a physiological measurement, not expert consensus or pathology.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The submission is focused on demonstrating equivalence for an expanded indication, so information about the original training of the algorithm (which likely happened for the predicate device DEN160044) is not detailed here.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established, but it can be inferred that it would have used the same physiological definition of hypotension (MAP < 65 mmHg for at least one minute) that is used for the device's indications for use and performance evaluation. This would involve continuous monitoring of MAP in a patient population.

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