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The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol enables consistent in the intended patient populations. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.

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

EV1000A:
The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner when it is used as a system with various Edwards' components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.

The EV1000 Clinical Platform includes an Acumen Hypotension Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP)

The provided text does not contain specific acceptance criteria with numerical thresholds or detailed study results for device performance related to specific clinical metrics. Instead, it describes general verification and validation activities conducted for software modifications and system functionality.

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 provide a table of acceptance criteria with specific performance metrics and their corresponding reported values. It generally states that "All tests passed" and that the device "meet their predetermined design and performance specifications."

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

The document mentions "retrospective data analysis for algorithm and performance verification" but does not specify the sample size for this analysis nor the country of origin. It also does not explicitly state whether the test set was retrospective or prospective, though the mention of "retrospective data analysis" suggests a retrospective component.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document mentions "an assessment by clinicians of its usability and human factors considerations" for usability testing. However, it does not specify the number of experts used to establish ground truth for any of the performance verification, nor their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This type of study seems irrelevant given the device's function as a monitoring platform rather than an AI-assisted diagnostic tool for image interpretation.

6. Standalone (Algorithm Only) Performance Study:

The document mentions that "Measured and derived parameters were tested using a bench simulation" and "individual components were tested at a sub-system level" and "integrated as a system and verified for their safety and effectiveness." This implicitly describes standalone (algorithm-only) performance testing against simulations and individual component verification. However, it does not provide detailed numerical results or specific performance metrics from these standalone tests.

7. Type of Ground Truth Used:

The ground truth for the verification activities appears to be based on:

• Predetermined design and performance specifications: The document states that the device "meet their predetermined design and performance specifications."
• Bench simulation: Used for testing "measured and derived parameters."
• Comparison to predicate devices: The submission aims to demonstrate substantial equivalence to predicate devices.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. The submission focuses on software modifications and verification, and if any machine learning algorithms were involved (e.g., for the Acumen HPI feature which was previously cleared), the details of their training are not part of this specific submission summary. The Acumen HPI feature itself was cleared in a separate submission (K183646), and this submission for K203131 only notes minor updates to its display.

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

Since a training set is not mentioned in this document, the method for establishing its ground truth is not provided.

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The EV 1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.

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 EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner when it is used as a system with various Edwards' components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient. The EV1000 Clinical Platform includes an Acumen Hypotension Prediction Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP)

This document is a 510(k) premarket notification for the Edwards Lifesciences EV1000 Clinical Platform. It describes a corrective action related to a hardware change in the AC inlet to prevent liquid ingress. The primary focus of the provided text is on demonstrating the safety and substantial equivalence of this modified device to a previously cleared predicate device, specifically regarding the hardware change.

Therefore, the study information requested (acceptance criteria related to device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details) is not detailed in this document. The document describes a design verification test for a hardware modification, not a clinical performance study of a device feature like the Acumen Hypotension Index (HPI).

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document states that "a reduction in occurrences of liquid ingress at the AC inlet was achieved." This implies an acceptance criterion related to reducing liquid ingress, but specific quantitative targets (e.g., maximum ingress rate, number of failures allowed) are not provided.
• Reported Device Performance: The document states that the device "successfully passed functional and bench studies to demonstrate that the device is substantially equivalent to the cited predicate device and the Power Adapter Cover reduces the possibility of fluid ingress." Again, specific quantitative performance metrics (e.g., exact reduction percentage, ingress test results) are not provided.

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

• Sample Size: Not specified. The document mentions "functional and bench studies" but does not detail the number of units tested.
• Data Provenance: Not specified, but given it's bench testing for a hardware modification, it would be laboratory data.

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

• Not applicable for this type of hardware verification study. "Ground truth" in the context of device performance, specifically for preventing liquid ingress, would be determined by physical measurements and observations during bench testing, not expert consensus.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting clinical data or images, not for bench testing hardware modifications.

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, an MRMC study was not done. This document pertains to a hardware modification for liquid ingress prevention, not the clinical performance or AI features of the device. The "Acumen Hypotension Index (HPI) feature" is mentioned as part of the overall device, but this submission is not a study of its effectiveness. It's a special 510(k) for a corrective action related to a physical design change.

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

• Not explicitly stated, but not applicable. This document describes a hardware change, not an evaluation of an algorithm's standalone performance. While the HPI is an algorithm, its performance evaluation is not the subject of this specific submission.

7. The type of ground truth used:

• For the liquid ingress test, the ground truth would be physical observation and measurement of liquid ingress during bench testing, as per relevant standards (e.g., IPX ratings).

8. The sample size for the training set:

• Not applicable. This document describes verification testing for a hardware change, not an AI model's training.

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

• Not applicable.

In summary, this 510(k) submission addresses a specific hardware modification for liquid ingress and demonstrates its safety and substantial equivalence through functional and bench studies. It does not contain the detailed clinical study information that would typically be provided for evaluating the performance of a diagnostic or predictive algorithm like the Acumen Hypotension Index. For such details, one would need to refer to separate 510(k)s or clinical trial reports specifically for those features.

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EV1000 Clinical Platform (EV1000A):

The EV 1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.

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

EV1000 Clinical Platform (EV1000A):

The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner when it is used as a system with various Edwards' components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.

The EV1000 Clinical Platform includes an Acumen Hypotension Prediction Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP)

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a 510(k) submission for modifications to existing devices (EV1000 Clinical Platform and EV1000 Clinical Platform NI) rather than a new device requiring extensive performance acceptance criteria for clinical efficacy. The primary purpose of this submission is a "Special 510(k) Corrective Action Being Effected" to address issues related to fluid exposure and power adapter orientation. Therefore, the acceptance criteria and performance reported are focused on the safety and functional integrity of these modifications.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not provide specific sample sizes for a "test set" in the context of clinical performance evaluation (e.g., patient numbers for diagnostic accuracy). Instead, it refers to "Design Verification testing" and "functional and bench studies" which are typically focused on engineering and safety validation, rather than clinical trials with patient cohorts.

• Sample Size for Test Set: Not explicitly stated in terms of patient numbers. The testing appears to be focused on bench and functional validation of the hardware changes.
• Data Provenance: Not specified, but given the nature of the modifications (hardware ingress protection, labeling), the testing would typically be conducted by the manufacturer in a controlled lab environment. There is no indication of clinical data from specific countries or whether it was retrospective or prospective.

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

This information is not applicable to the type of safety and functional testing described. The "ground truth" for the acceptance criteria outlined above would be established through engineering specifications, regulatory standards for ingress protection (e.g., IP ratings), and functional performance benchmarks, rather than expert clinical consensus.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert reviewers evaluate performance against a golden standard. For hardware and functional testing, the "adjudication" is based on objective measurements and compliance with engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not performed. The submission focuses on hardware modifications and labeling changes to address safety concerns, not on assessing reader performance or the clinical interpretation of the device's outputs.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The EV1000 Clinical Platforms are medical monitoring devices that generate physiological parameters for clinicians. The "Acumen Hypotension Prediction Index" (HPI) feature is an algorithm that provides "additional quantitative information regarding the patient's physiological condition for reference only," explicitly stating "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This indicates it's designed to be used with human interpretation, not as a standalone diagnostic or therapeutic tool. The current submission, however, is not about the HPI's performance but modifications to the physical device.

7. The Type of Ground Truth Used:

For the EV1000A, the "ground truth" for the corrected issue (power adapter orientation) is simply the correct physical orientation as defined by engineering and safety standards, communicated via labeling.

For the EV1000NI, the "ground truth" for the corrected issue (liquid ingress) would be objective measurements of liquid ingress (e.g., in milliliters or by visual inspection for presence of liquid) compared against a pre-defined acceptance threshold that demonstrates adequate protection, typically derived from engineering and safety standards (e.g., IEC 60601-1, IP ratings).

8. The Sample Size for the Training Set:

Not applicable. This submission is for modifications to existing cleared devices, not for the development or training of a new algorithm or AI model. The Acumen HPI, which does involve an algorithm, was part of a prior submission (K183646) and would have had its own training and validation data, but that is not the subject of this specific 510(k).

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

Not applicable, as there is no mention of a training set for this specific 510(k) submission.

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

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

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

1. Acceptance Criteria and Reported Device Performance

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

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The EV1000 Clinical Platform NI and the ClearSightTM Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the non-invasive system is indicated or use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV 1000 Clinical Platform and the ClearSightTM Finger Cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The EV1000 Clinical Platform NI and the ClearSight™ Finger Cuffs is a non-invasive system that continuously measures blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform. The EV1000 Clinical Platform NI and the ClearSight™ Finger Cuffs consists of the EV1000 monitor (EV1000M), the EV1000 Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (EVHRS or also referred to as HRS), and the ClearSight™ Finger Cuffs. EV1000M may be attached to the patient bedside, an IV pole or roll stand. The subject of this 510(k) is a change of the tubing material and its establishment of shelf life for the EVHRS, a component of the subject device, EV1000 Clinical Platform NI and the ClearSight Finger Cuff.

This document is a 510(k) premarket notification for a medical device called the EV1000 Clinical Platform™ NI and the ClearSight™ Finger Cuffs or ClearSight™ System. The submission, K182245, is seeking substantial equivalence to a previously cleared device (K160552) for a change in tubing material and shelf life of a component, the Heart Reference Sensor (EVHRS).

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria related to its performance as a blood pressure measurement system after the material change. The provided text primarily focuses on demonstrating substantial equivalence for engineering/material changes, not clinical performance changes.

Therefore, many of the requested details cannot be extracted from this document because they pertain to a performance study for a medical device AI/software, not a material change to an existing device component.

However, I can extract the following:

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

The document states: "functional testing was conducted to show performance is not affected. The EVHRS has been shown to be substantially equivalent to the predicate device for its intended use in hospitals and other appropriate clinical environments. The Heart Reference Sensor (EVHRS) accessory to the subject device, EV1000 Clinical Platform NI and the ClearSight™ Finger cuffs have successfully passed functional and performance testing, including mechanical, shelf life, biocompatibility, and bench studies, demonstrating that the subject device is substantially equivalent to the predicate device."

This implies that the acceptance criteria for this specific 510(k) (K182245) related to the change in tubing material were that the performance characteristics of the device, as measured by functional, mechanical, shelf life, biocompatibility, and bench studies, remained equivalent to the predicate device. However, specific numerical acceptance criteria or reported performance data are NOT provided in this document. It only states that the tests were "successfully passed."

The remaining questions (2-9) cannot be answered from the provided text as they relate to clinical performance studies, particularly for AI/software, which are not the subject of this specific 510(k) submission. This 510(k) (K182245) is for a material change and shelf-life establishment of a component (EVHRS), not the initial clinical validation of the blood pressure measurement capabilities of the EV1000 system. The clinical performance and ground truth for the overall device would have been established during the clearance of the predicate device (K160552 and K140312).

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The EV1000 Clinical Platform NI and the ClearSightTM Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the non-invasive system is indicated for use in patients with co- morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.

The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner when it is used as a system with various Edwards' components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.
The EV1000 Clinical Platform consists of the EV1000 Monitor (Monitor), the EV1000 Databox (Databox), and an Ethernet cable to connect the Databox to the Monitor. It may be attached to the patient bedside, an IV pole or roll stand.
The EV1000 Clinical Platform NI with ClearSight Finger Cuffs is a non- invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peñàz - Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform.
The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000 Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight™ Finger Cuffs. It may be attached to the patient bedside, an IV pole or roll stand.

This FDA 510(k) summary provides information for the EV1000 Clinical Platform NI with ClearSight™ Finger Cuffs or ClearSight™ System.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the clinical study as demonstrating substantial equivalence to the predicate device. However, it does not explicitly list specific numerical acceptance criteria (e.g., accuracy thresholds, precision ranges) for individual hemodynamic parameters, nor does it provide a precise table of the device's reported performance against such criteria. The "Comparative Analysis" and "Functional/Safety Testing" sections state that the device's performance and functionality were compared to the predicate device, and the device was shown to be "safe, effective, and substantially equivalent."

Therefore, I cannot populate a table with specific numerical acceptance criteria and reported device performance from the provided text. The evaluation focused on substantial equivalence rather than meeting pre-defined numerical thresholds for accuracy or precision.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for the Test Set (Clinical Study): The document states that "an evaluation of archived clinical data demonstrated that the device is substantially equivalent to the cited predicate device." It also mentions "a clinical study" in the "Comparative Analysis" section. However, the exact sample size (number of patients or data points) for this clinical study or the evaluation of archived data is not specified in the provided text.
• Data Provenance (e.g., country of origin, retrospective or prospective): The document refers to "archived clinical data," which implies a retrospective evaluation. The country of origin of this data is not specified.

3. Number of Experts and Their Qualifications for Ground Truth

The document does not mention the involvement of experts (e.g., radiologists) to establish ground truth for the test set. Instead, it refers to the device measuring blood pressure and deriving hemodynamic parameters based on the "scientific method of Peñàz - Wesseling" and comparison to a predicate device. This suggests that the "ground truth" or reference standard for comparison would likely be the measurements obtained from the predicate device or a clinical gold standard for blood pressure measurement, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Since the establishment of ground truth by multiple experts is not mentioned, an adjudication method is not applicable and therefore not described in the provided text.

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

An MRMC study is relevant for devices that involve human interpretation, such as AI for medical imaging. The EV1000 Clinical Platform NI with ClearSight™ Finger Cuffs is a hemodynamic monitoring device, not an imaging device that requires human interpretation in the same way. Therefore, an MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device based on the information provided. The study focused on device performance and functionality comparison with a predicate, not how human readers improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The device described, the EV1000 Clinical Platform NI, is a continuous monitoring system that directly measures and derives physiological parameters. Its performance, as described, is its standalone performance without explicit human intervention in the real-time measurement or derivation of parameters. The "Functional/Safety Testing" included "software verification and validation, mechanical and electrical testing, and bench studies," which would assess its standalone operational accuracy. The evaluation of archived clinical data also represents a standalone assessment of the device's output against a reference. Therefore, yes, its performance described is essentially its standalone (algorithm only) performance.

7. Type of Ground Truth Used

The type of ground truth used for comparison during the "clinical study" and "evaluation of archived clinical data" was likely:

• Measurements from the predicate device (K140312 – EV1000 Clinical Platform™ NI with ClearSight™ Finger Cuffs or ClearSight™ System).
• A clinically established gold standard for blood pressure and hemodynamic parameter measurement, which the predicate device itself would have been compared against during its clearance. This could involve invasive arterial line measurements for blood pressure or other established methods for cardiac output and fluid volume assessment not explicitly detailed in this summary.

8. Sample Size for the Training Set

The document focuses on the evaluation of the device, which typically refers to testing its performance rather than training an AI model. While the device uses a "scientific method" (Peñàz - Wesseling) and derives parameters, there is no mention of an AI algorithm that was "trained" on a specific dataset as would be the case for machine learning devices. Therefore, a "training set" for an AI algorithm is not explicitly mentioned or applicable in the context presented.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not provided.

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The EV1000 Clinical Platform and the ClearSight™ Finger Cuffs are indicated for patients over 18 years of age in which the balance between. cardiac function, fluid status, and vascular resistance needs continuous assessment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSight™ finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The EV1000 Clinical Platform with ClearSight Finger Cuffs is a non- invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peňáz - Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform. The EV1000 ClearSight™ System consists of a monitor, a pump-unit, a pressure controller that is worn on the wrist, and ClearSight Finger cuffs. The EV1000 Pump-unit receives incoming signals from the pressure controller and the finger cuffs. The algorithms embedded in the Pump- Unit and the pressure controller process signals from the finger cuffs and provide parameter calculations. The EV1000 Monitor is connected to the Pump-Unit via an Ethernet cable, and the Pump-unit is connected to the pressure controller via a RS485 port. The monitor is a touchscreen panel PC with a graphical user interface (GUI). The monitor displays the measured and calculated parameters from the Pump-Unit.

The provided text describes the EV1000 Clinical Platform with ClearSight™ Finger Cuffs, a non-invasive blood pressure measurement system. The submission focuses on demonstrating substantial equivalence to a predicate device through verification and validation testing, including a clinical study.

Here's an analysis of the acceptance criteria and study details based on the provided text:

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

The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes meeting acceptance criteria through a comparison to a predicate device.

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 "a clinical study" was conducted. However, it does not specify the sample size used for this clinical study (test set). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

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 provide any information regarding the number of experts used to establish ground truth or their qualifications. Given that the device measures physiological parameters (blood pressure), ground truth would likely be established through a reference measurement method, rather than expert interpretation of images/data.

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

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

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

The document describes a comparative effectiveness study, but it is not an MRMC study comparing human readers with and without AI assistance. This device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for human readers. The comparative effectiveness study focuses on the device's performance against a predicate device. Therefore, there is no mention of an effect size related to human reader improvement with AI.

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

The device itself is a standalone non-invasive blood pressure monitor that measures and calculates parameters. The "clinical study" would inherently assess the performance of this device in a standalone manner against a reference method or predicate device. The document states "a clinical study demonstrated that the device is substantially equivalent to the cited predicate device." This implies standalone performance was assessed.

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

While not explicitly stated, for a non-invasive blood pressure monitor, the "ground truth" in a clinical study would typically be established by simultaneous measurements from a reference invasive blood pressure monitoring system (e.g., arterial line) or another highly accurate, validated non-invasive method. The document does not specify the exact method used for ground truth.

8. The sample size for the training set

This document describes a medical device seeking 510(k) clearance, not an AI/Machine Learning model that undergoes explicit "training." Therefore, there is no concept of a training set sample size as it would apply to AI. The device's algorithms are embedded and validated through testing, not iterative training on a large dataset in the AI sense.

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

As described in point 8, there isn't a "training set" in the context of an AI model for this device. The device's underlying scientific method (Peňáz - Wesseling) and embedded algorithms are based on established physiological principles and likely validated through extensive engineering and clinical testing, not ground truth labeling for a training set.

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The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.

The EV1000 Clinical Platform consists of Databox and Monitor components, which can be mounted to an IV pole. The EV1000 Clinical Platform measures patient physiologic parameters when it is used as a system with various Edwards components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.

The EV1000 Databox receives incoming signals from the patient through the connections provided by the accessories applied to the patient. The algorithms embedded in the Databox process the signals and provide parameter calculations.

The EV1000 Monitor is connected to the Databox via an ethernet cable. The Monitor is a touchscreen, panel PC with a graphical user interface (GUI). The Monitor displays the measured and calculated parameter values from the Databox.

The EV1000 Clinical Platform, when used with the VolumeView System, measures and/or calculates hemodynamic parameters such as: Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume. Manual-calibrated intermittent parameters: cardiac output, cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index.

When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates auto-calibrated arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.

When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters (specifically mixed venous oximetry (SvO2) and central venous oximetry (ScvO2).

Here's a breakdown of the acceptance criteria and the study information for the EV1000 Clinical Platform, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the EV1000 Clinical Platform is a 510(k) summary and approval letter, not a detailed study report with specific acceptance criteria and quantitative performance metrics. Therefore, a direct table of numerical "acceptance criteria" and "reported device performance" as one might find for accuracy or precision claims is not available in the provided text.

Instead, the acceptance criteria here are broad statements related to safety, effectiveness, and substantial equivalence to a predicate device. The device performance is described in terms of having "successfully passed functional and performance testing."

Here's how we can infer and represent the information:

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions "comparison testing of clinical cases" and "comparative analysis of clinical data" but does not give a number of cases or patients.
• Data Provenance: Not explicitly stated regarding country of origin. The study included "bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." No indication if these were retrospective or prospective, or geographically where they were conducted.

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

• Number of Experts: Not applicable/Not stated. For a device like the EV1000 Clinical Platform, "ground truth" for its measurements (e.g., cardiac output, stroke volume) would typically be established by validated reference methods or the predicate device itself, not by a panel of human experts reviewing observational data.
• Qualifications of Experts: Not applicable/Not stated for the reason above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not stated. Since the "ground truth" for this type of device is usually based on empirical measurements and comparison to a predicate, rather than subjective expert interpretation, an adjudication method for conflicting expert opinions is not relevant or described.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is measured. This device is a physiological monitoring platform, hence such a study design is not relevant here.
• Effect Size with AI vs. Without AI Assistance: Not applicable for the reasons above.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

• Standalone Study: Yes, implicitly. The nature of the device (a cardiac output/oximetry computer) means its core function is to autonomously process signals and calculate parameters. The "functional and performance testing" and "bench studies" inherently evaluate the algorithms' performance in a standalone manner, separate from human interpretation of raw signals. The comparison to the predicate device also assesses the algorithm's output. While not explicitly termed a "standalone study," the entire evaluation process focuses on the device's algorithmic and hardware performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the EV1000 Clinical Platform would be derived from:
  • Validated Reference Methods: For quantitative physiological parameters, this would involve comparing the device's measurements to established, gold-standard methods (though these specific methods are not detailed in the summary).
  • Predicate Device Comparison: A significant part of the substantial equivalence claim relies on "side-by-side bench and pre-clinical studies, and comparative analysis of clinical data" against the EV1000 Clinical Platform, K110597 (the predicate). The measurements from the predicate device serve as the reference.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not stated. This summary describes a device that likely uses established physiological algorithms and signal processing, rather than a machine learning or AI model that requires a dedicated "training set" in the modern sense of deep learning. The algorithms are "embedded in the Databox." Therefore, there isn't a "training set" as one would discuss for, say, an image recognition AI. If any form of algorithm tuning or development data was used, it's not documented here.

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

• Ground Truth for Training Set: Not applicable/Not stated for the same reasons as #8.

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The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.

The EV1000 Clinical Platform consists of a Databox and Monitor components, which can be mounted to an IV pole. The EV1000 Clinical Platform measures patient physiologic parameters when it is used as a system with various Edwards components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.

The EV1000 Databox receives incoming signals from the patient through the connections provided by the accessories applied to the patient. The algorithms embedded in the Databox process the signals and provide parameter calculations.

The EV1000 Monitor is connected to the Databox via an ethernet cable. The Monitor is a touchscreen, panel PC with a graphical user interface (GUI). The Monitor displays the measured and calculated parameter values from the Databox.

The EV1000 Clinical Platform, when used with the VolumeView System, measures and/or calculates hemodynamic parameters such as:
• Auto-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation;
• Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; and,
• Manual-calibrated intermittent parameters: cardiac output , cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index.

When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.

When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters.

Acceptance Criteria and Study for EV1000 Clinical Platform

This document describes the acceptance criteria and the study performed to demonstrate that the EV1000 Clinical Platform meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it describes a comprehensive testing regimen designed to demonstrate the device's "safety and effectiveness and substantial equivalence to the cited predicate devices." The performance reported is that the EV1000 Clinical Platform has been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use.

The comparative analysis and functional/safety testing sections indicate that the device met the performance and functionality of the predicate devices. Therefore, the implicit acceptance criteria are that the EV1000 Clinical Platform performs comparably to its predicate devices in terms of functionality and safety without introducing new questions of safety or effectiveness.

Implicit Acceptance Criteria and Reported Device Performance:

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

The document states:

• Archived clinical data: This implies retrospective data.
• Clinical data obtained during a multi-center clinical trial: This implies prospective data.
• The country of origin is not specified, but Edwards Lifesciences LLC is based in Irvine, CA.

However, specific sample sizes for the test sets used in the comparative analysis, bench studies, pre-clinical studies, or multi-center clinical trial are not provided in the summary.

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

This information is not provided in the 510(k) summary. The document does not mention the use of experts to establish ground truth for the test set. Given the nature of the device (measuring physiological parameters), ground truth would typically be established by established medical measurement methods or reference devices, not expert consensus in the traditional sense of image interpretation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. As mentioned above, for physiological parameter measurements, ground truth is usually established by comparison to reference methods rather than human adjudication.

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

An MRMC study is relevant for devices involving human interpretation of clinical data (e.g., imaging devices). The EV1000 Clinical Platform measures and calculates physiological parameters directly. Therefore, a MRMC comparative effectiveness study was not conducted as it is not applicable to this type of device. The study involved comparing the device's measurements against predicate devices or established methods, not assessing human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

The device itself is an algorithm-driven platform for measuring and calculating physiological parameters. The entire study described, which includes head-to-head bench and pre-clinical studies, and comparative analysis of clinical data, is essentially a standalone performance assessment of the EV1000 Clinical Platform's algorithms and hardware in measuring these parameters. It doesn't involve a human-in-the-loop scenario where a human is assisting the algorithm's output for diagnosis or interpretation. The device provides information to human clinicians.

7. Type of Ground Truth Used

Based on the description of device functionality and the testing methods, the ground truth would likely be established through:

• Reference physiological measurements: Comparing the device's output to measurements obtained from established, validated methods or "gold standard" devices for hemodynamic and oximetry parameters.
• Pathology/Outcomes data: While not explicitly stated, clinical outcomes or direct physiological measurements taken during procedures would serve as the ultimate ground truth for validating the accuracy and clinical utility of the measured parameters.
• Predicate device comparison: The study explicitly mentions "head-to-head bench and pre-clinical studies, and comparative analysis of archived clinical data and clinical data obtained during a multi-center clinical trial of the EV1000 Clinical Platform" against predicate devices. This implies the predicate devices' performance serves as a form of "ground truth" or reference for evaluating substantial equivalence.

8. Sample Size for the Training Set

The document does not specify a sample size for any training set. The EV1000 Clinical Platform is a measurement device with embedded algorithms, not a machine learning "AI" device as typically understood that undergoes a distinct training phase on a large dataset. Its algorithms are likely based on established physiological models and signal processing, rather than being "trained" in the machine learning sense. The "comparative analysis" refers to testing the device's performance, not training it.

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

As noted above, a distinct "training set" in the context of machine learning is not indicated for this device. Therefore, this information is not applicable and not provided in the summary. The algorithms' inherent accuracy would be based on underlying scientific principles and engineering design, with performance validated through the testing described.

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