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Indications for Use: 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-Gatheter 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 pediatric critical care patients requiring of venous 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 < 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.

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

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

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

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

• When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >40 kg.

· When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >3 kg.

· When used with small sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects < 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 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 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 ClearSight finger cuff indications for information on target patient population specific to the finger cuff being used.

Intended Use of HemoSphere Advanced Monitor: 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, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs.

Intended Use of Viewfinder Remote: Viewfinder Remote is a mobile application, which provides supplemental remote near real-time display of hemodynamic data measured by a connected HemoSphere advanced monitoring platform. Viewfinder Remote allows clinicians to view continuous monitoring data and alarms/alerts remotely for multiple patients. All displayed data is generated by connected HemoSphere advanced monitoring platforms, and not by Viewfinder Remote. Viewfinder Remote is intended for use by clinicians as a supportive visual aid, and not as a replacement for in-person patient monitoring with connected HemoSphere advanced monitoring platforms.

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 consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and 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 Tissue Oximeter Module (K190205 August 29, 2019), HemoSphere ForeSight Oximeter Cable (K213682 cleared June 22, 2022). and the HemoSphere ClearSight Module (K203687 cleared May 28, 2021).

The regulatory submission K223127 for the HemoSphere Advanced Monitoring Platform indicates a modification to the existing StO2 algorithm of the HemoSphere ForeSight Oximeter Cable. The submission claims substantial equivalence to a predicate device (K213682 cleared June 22, 2022) and an additional predicate (Fore-Sight Elite Module Tissue Oximeter, K143675 cleared April 10, 2015) for the StO2 algorithm.

Here's an analysis based on the provided text, fulfilling the requested information points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All testing passed without exception" and the "modification did not adversely affect the safety and effectiveness of the subject device." However, specific numerical acceptance criteria (e.g., accuracy +/- X%, bias Y, precision Z) and the corresponding reported performance values for the StO2 algorithm are not explicitly provided in the given text.

The text vaguely indicates that:

• "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
• "The same methods, protocols and acceptance criteria as the predicate device (K213682) were used to evaluate the modification."
• "Design, materials, energy source, user interface, measurement principle and all performance specifications of the modified HemoSphere ForeSight Oximeter cable remain unchanged."

Without the actual specific criteria and reported values from the predicate device's clearance, a detailed table with numerical data cannot be generated from this document.

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

The document does not specify the sample size used for the test set. It mentions "Algorithm Verification" and "System Verification" without detailing the number of cases or patients included in these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not provided.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Given that the modified device measures "absolute regional hemoglobin oxygen saturation (StO2)," the ground truth would typically be established through a reference method (e.g., co-oximetry of arterial and venous blood samples, or another validated oximetry technique) rather than expert consensus on images.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set.

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

The document does not indicate that an MRMC comparative effectiveness study was performed. The device is a monitoring platform providing quantitative physiological parameters, not an imaging device requiring human reader interpretation in the same way.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study of the algorithm was done. The submission explicitly states:

• "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
• "The results establish that the modification did not adversely affect the safety and effectiveness of the subject device."

This "Algorithm Verification" section refers to directly testing the algorithm's performance.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used but implies it would be a comparison to existing specifications from the predicate devices. For a tissue oximeter measuring StO2, the ground truth would typically involve comparison to a validated reference method for oxygen saturation, possibly through in-vivo or in-vitro testing. It is not expert consensus on images or pathology in this context.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. This is a modification to an existing algorithm, so the original algorithm would have been developed and trained, but details about that original training are not in this submission.

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

The document does not provide details on how the ground truth for the training set (of the original algorithm) was established. It only refers to the modification of an "existing StO2 algorithm."

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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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The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

The Edwards Lifesciences Pressure Monitoring kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data.

The TruWave disposable pressure transducer has a straight, flow through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.

The provided text is a 510(k) summary for a medical device, the TruWave Disposable Pressure Transducer. It describes the device, its intended use, and the regulatory determination of substantial equivalence.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device, which is what the prompt is asking for. The device described (a pressure transducer) is a physical medical device, not an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from the provided document as it is not relevant to an AI/ML device study.

The document discusses:

• Device Name: TruWave Disposable Pressure Transducer
• Regulation Number: 21 CFR 870.2870 (Catheter Tip Pressure Transducer)
• Indications for Use: For patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
• Substantial Equivalence: To predicate devices K171996 and K142749.
• Testing: Mentions "successfully passed biocompatibility and functional testing," but no details on the specific performance metrics or acceptance criteria for these tests are provided, nor is there any mention of AI/ML performance metrics. The "functional testing" broadly refers to the device's physical operation, not an AI algorithm's performance.

To answer your prompt, I would need a document detailing the clinical validation or performance study of an AI/ML medical device, including its acceptance criteria and how it was proven to meet them.

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