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510(k) Data Aggregation
(162 days)
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 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 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 oximetry catheters is indicated for use in adult and pediatric crtical 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 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. 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 Technology Module (K190205 August 29, 2019). HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).
The provided FDA 510(k) summary (K221704) for the HemoSphere Advanced Monitoring Platform does not contain a table of acceptance criteria and reported device performance for the modifications made (specifically the Right Ventricular Pressure (RVP) algorithm). While it states that "All tests passed" and "demonstrated that the subject devices meet their predetermined design and performance specifications," specific numerical performance metrics and their corresponding acceptance criteria are not detailed in this document.
However, based on the information provided, here's a breakdown of the other requested information regarding the study supporting the device:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document states that "all performance verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications" and "All tests passed," but it does not specify the quantitative acceptance criteria or the numerical results achieved by the device against those criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm."
- Sample Size for Test Set: Not specified. The document does not provide the number of patients or waveforms used for the clinical data collection for the RVP algorithm validation.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable/Not specified. The document mentions the collection of "clinical data (waveforms)" for the RVP algorithm validation, but it does not describe a process involving human experts to establish ground truth from this data. The RVP algorithm likely derives its parameters directly from physiological waveform data obtained from the Swan-Ganz Module and Pressure Cable, rather than relying on expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable/Not specified. As there is no mention of human expert-established ground truth, an adjudication method is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance in a comparative context. The device focuses on monitoring physiological parameters rather than image interpretation or diagnostic tasks involving human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The validation of the RVP algorithm described in the document is a standalone performance assessment. The statement "Clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm" implies that the algorithm's performance was evaluated based on this collected data. The conclusion that the device "has successfully passed functional and performance testing, including software and algorithm verification and validation and bench studies" further supports that the algorithm's performance was assessed. However, specific standalone performance metrics are not provided.
7. Type of Ground Truth Used for the Test Set
The ground truth for the RVP algorithm's validation would be the physiological waveform data itself, specifically from the Swan-Ganz Module and Pressure Cable. The algorithm processes this raw physiological data to derive parameters like SYSRVP, DIARVP, MRVP, PRRVP, RV dp/dt, and RVEDP. The validation would involve comparing the algorithm's derived parameters against established methods or calculations from the same direct physiological measurements (e.g., from the Swan-Ganz catheter and pressure sensors).
8. Sample Size for the Training Set
Not specified. The document mentions "clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm," but it does not differentiate between data used for design/training and data used specifically for validation (test set), nor does it specify the sample size for any such training.
9. How the Ground Truth for the Training Set Was Established
Not specified/Not explicitly described. Given that the RVP algorithm processes physiological signals from existing, cleared hardware, the "ground truth" for any potential training would inherently be the raw physiological signals themselves, as measured by the Swan-Ganz Module and Pressure Cable. The algorithm's development would likely be based on established physiological principles and signal processing techniques to derive the mentioned RVP parameters. The document does not detail a specific "training set" or a separate process for establishing ground truth for training data beyond the intrinsic nature of the physiological measurements.
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(212 days)
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.
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 (previously referred to as "Tissue Oximetry Module"; K190305 cleared, August 29, 2019), HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K203687 cleared, May 28, 2021). 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.
The provided text describes several features and modifications to the HemoSphere Advanced Monitoring Platform, but it does not contain a specific table of acceptance criteria and reported device performance, nor does it detail a standalone AI algorithm study or an MRMC comparative effectiveness study for the machine learning features (like HPI or AFM).
The document primarily focuses on demonstrating substantial equivalence to predicate devices, and the performance data mentioned is generally high-level "All tests passed" rather than specific quantitative results against defined acceptance criteria for AI model performance.
Therefore, many of the requested details about the study that proves the device meets the acceptance criteria (especially for the AI/ML features) are not available in this document. The information that can be extracted relates more to the overall device functionality and compliance than to a detailed AI performance validation.
Based on the provided text, here's what can be extracted and what information is missing:
Information NOT available in the document regarding acceptance criteria and AI study specifics:
- 1. A table of acceptance criteria and the reported device performance for AI features: This level of detail is not provided. The document states that "Completion of all performance verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications," and "Measured and derived parameters were tested using a bench simulation. Additionally, individual modules were tested at a system level to verify the safety of these modules." However, it does not enumerate specific acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) or quantitative performance results for the AI algorithms (HPI, AFM).
- 2. Sample size used for the test set and the data provenance, whether retrospective or prospective: This information is not provided. The document mentions "bench simulation" and "system level" testing but does not quantify the dataset size or its nature.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The document states, "No new clinical testing was performed in support of the subject 510(k)," indicating that specific MRMC studies for this submission were not conducted.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document states that the "Acumen Hypotension Prediction Index feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter," and similarly for AFM, "No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions." This implies the AI features are intended for human-in-the-loop use, but it doesn't explicitly refer to a "standalone" performance study in the context of a typical AI performance evaluation. It does mention "Measured and derived parameters were tested using a bench simulation," which could include algorithm-only testing, but specific metrics are absent.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
- 8. The sample size for the training set: Not specified.
- 9. How the ground truth for the training set was established: Not specified.
Information that CAN be inferred or extracted (though limited for AI-specific performance):
- Regarding "Acumen Hypotension Prediction Index Feature" and "Acumen Assisted Fluid Management Feature":
- The document explicitly states that for the Acumen HPI feature, "No modifications have been made to the previously granted AFM algorithm" (referring to the core algorithm, K203687), and for HPI Smart Alerts/Trends modifications, "There are no changes to the core HPI algorithm, the behavior of the HPI parameter display, nor the indications for use and intended use of the HPI parameter due to this Smart Trends/ Smart Alerts modification." This suggests that the core algorithms for HPI and AFM were previously cleared (DEN190029 for AFM and K203687 for HPI), and this submission focuses on incorporating and updating the display and connectivity of these features rather than re-validating the core algorithms themselves. This means the detailed AI performance validation, if done, would have been part of the previous submissions (DEN190029 and K203687).
- The HPI feature defines hypotensive events as "mean arterial pressure
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(58 days)
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 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 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 SevO2) 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 Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 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.
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 Oximetry Module (K190205 August 29, 2019), HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 cleared October 1, 2020).
The HemoSphere Advanced Monitor (K201446 most recently cleared October 1, 2020), subject of this submission, is being modified to enable connectivity to a Viewfinder Remote mobile application via a software-based Viewfinder Hub and Viewfinder Cloud.
The Viewfinder Remote mobile application provides clinicians with a supplemental near-real time display of the patient hemodynamic data from the connected HemoSphere Advanced Monitoring Platform. The Viewfinder Remote application is part of the Edwards Viewfinder network, which includes Viewfinder Hub and Viewfinder Cloud. The Viewfinder Remote mobile application functions as a supportive visual aid for patient status communication between clinicians and allows them to view multiple patient monitoring sessions at once from their mobile device. The near-real time updates to patient monitoring sessions includes non-invasive hemodynamic parameter data and the associated physiological alarm notifications, historical trend data and parameter waveform data.
The provided text describes modifications to an existing device, the HemoSphere Advanced Monitoring Platform, to include a new feature: the Viewfinder Remote mobile application. The primary predicate device is the HemoSphere Advanced Monitoring Platform itself (K201446). The submission focuses on the addition of the Viewfinder Remote and changes to the HemoSphere Advanced Monitor to support this remote viewing functionality.
The acceptance criteria and study information provided are primarily related to the safety and functionality of the new remote viewing feature and the integrated system, rather than the clinical performance of the underlying hemodynamic monitoring parameters. No clinical performance data is deemed necessary for the modifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for parameters like accuracy, sensitivity, or specificity for the Viewfinder Remote mobile application. Instead, it states that "All tests passed" for various verification activities, implying that the device met internal performance specifications for these tests. The focus is on ensuring data integrity, safety, and usability of the remote viewing function.
| Acceptance Criteria Category | Specific Test/Description | Reported Device Performance |
|---|---|---|
| System Verification | End-to-end system verification for data integrity and accuracy (Monitor to Remote View mobile application) | All tests passed. |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34 and IEC 60601-2-49 standards | All tests passed. |
| Wireless Coexistence | ANSI C63.27/D1.0, bench and simulated environment testing on the entire platform, including modules and the Viewfinder Remote | All tests passed. |
| Software Verification | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | All tests passed. (HemoSphere Advanced Monitor: Major Level of Concern; Viewfinder Remote: Moderate Level of Concern) |
| Usability Study | FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices" | All tests passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the verification tests (system, wireless, software, usability). It does not mention clinical data proving the device meets the acceptance criteria, as clinical data was not required for the modifications. The tests appear to be non-clinical (bench and simulated environment).
- Test Set Sample Size: Not specified.
- Data Provenance: Non-clinical (bench and simulated environment testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The verification activities mentioned are technical and regulatory compliance tests, not typically requiring expert ground truth in the way a diagnostic algorithm's performance would. For the usability study, "clinicians" are mentioned as users, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided.
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 such study was mentioned. The device (Viewfinder Remote) is a "supportive visual aid" for remote display of parameters, not an AI-assisted diagnostic tool that would improve human reader performance in interpreting complex medical images or data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Viewfinder Remote itself is a standalone application in the sense that it displays data from the HemoSphere monitor, but its "performance" is based on accurately reflecting the data generated by the primary monitoring platform. The verification activities focus on the integrity and accuracy of this data transfer and display, not on the Viewfinder Remote generating independent algorithmic outputs. The "Acumen Hypotension Prediction Index Feature" is mentioned as a component of the HemoSphere system, providing "additional quantitative information," but the document doesn't detail standalone performance studies for this specific AI feature outside of its integration with the HemoSphere platform and the context of the Viewfinder Remote submission.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the HemoSphere Advanced Monitoring Platform itself, the ground truth for its core hemodynamic parameters would typically be established through validation against gold-standard invasive measurements or other well-established methods. However, for the modifications related to the Viewfinder Remote, the "ground truth" for the verification tests involved comparing the displayed data on the remote application against the data displayed on the primary HemoSphere monitor, and ensuring it passed technical and regulatory standards.
- For the Viewfinder Remote modifications: The ground truth for data integrity and accuracy would be the parameters and alarms generated and displayed on the HemoSphere Advanced Monitor itself.
- For the overall HemoSphere Advanced Monitor (implied from its existing clearance K201446 and general device type): Ground truth for hemodynamic parameters like cardiac output, pressure, and oxygen saturation would typically rely on established clinical measurement techniques (e.g., thermodilution for CO, direct arterial line measurement for BP, co-oximetry for SvO2).
8. The Sample Size for the Training Set
This information is not provided. Given that clinical data was not required for these specific modifications, and the focus is on a remote display application rather than a new diagnostic algorithm requiring extensive training data, a training set as typically understood for AI models is not explicitly mentioned. If the Acumen HPI feature involves AI, its training data details are not provided in this document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. (See point 8).
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(206 days)
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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| System Verification | Measured and derived parameters were tested using a bench simulation. Individual modules and integrated system were verified for safety and effectiveness. All tests passed. |
| Electrical Safety & EMC | The HemoSphere Advanced Monitor and HemoSphere Pressure Cable were tested to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34 and IEC 60601-2-49 standards. All tests passed. |
| Wireless Coexistence | Bench and simulated environment testing was performed on the entire HemoSphere Advanced Monitoring Platform, including all sub-system modules and interfacing analog inputs and outputs. All tests passed. |
| Software Verification | Software verification was performed per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software on each individual module was tested at a sub-system level. All tests passed. |
| Usability Study | A usability study was performed in accordance with FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Test Passed. |
| Clinical Performance | Clinical data was not required for this device. (This implies the acceptance criterion for clinical performance was that existing predicate data and non-clinical testing were sufficient to demonstrate substantial equivalence, and no new clinical study was deemed necessary by the FDA for this submission.) |
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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