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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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