Search Results

The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's biometric data are entered, the PulsioFlex Monitor presents the derived parameters indexed.

• With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.
• With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.
• With the ProAQT Sensor, the PulsioFlex Monitoring System uses arterial pulse contour analysis for continuous hemodynamic monitoring.
  The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.

The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components:
a) PulsioFlex Monitor
b) PiCCO Module
c) CeVOX Optical Module
d) ProAQT Sensor

Here's a breakdown of the acceptance criteria and study information for the PulsioFlex Monitoring System with ProAQT Sensor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for the device's diagnostic capabilities. Instead, it focuses on general performance testing, software verification, safety, and biocompatibility.

General Performance Criteria (Implicit from "Performance Data"):

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

The document does not explicitly state a specific "test set" with a defined sample size for a clinical validation or diagnostic performance study in the way one might expect for an AI/ML device. The "Clinical Performance" section mentions "Clinical data demonstrates that the pulse contour algorithm is able to process pressure signals from femoral, brachial, axillary and also radial artery adequately." This suggests a clinical study was performed, but details on sample size (number of patients, number of measurements), country of origin, or retrospective/prospective nature are not provided.

The other performance tests (visual, lifetime, software verification, safety, etc.) are generally performed on a sample of devices or components, but details on those sample sizes are also not provided in this summary.

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

This information is not provided in the document. The type of device (hemodynamic monitor) does not typically rely on "expert ground truth" in the same way an imaging AI diagnostic might. Its ground truth for pulse contour analysis would typically be established by established invasive direct measurement methods (e.g., thermodilution cardiac output) or accepted physiological principles.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device, it is unlikely that a human adjudication method like "2+1" or "3+1" was applied for its performance evaluation, as it's not an AI diagnostic dependent on human interpretation for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed or described in this document. This type of study is typically done for AI diagnostic tools that aid human interpretation of complex data (like medical images), which is not the primary function described here.

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

The "Clinical Performance" section states: "Clinical data demonstrates that the pulse contour algorithm is able to process pressure signals from femoral, brachial, axillary and also radial artery adequately." This implies standalone performance of the algorithm in deriving physiological parameters from raw pressure signals. The "PulsioFlex Monitoring System with ProAQT Sensor determines the cardiac output by means of pulse contour analysis. The ProAQT Sensor is connected in series to a pre-installed blood pressure measurement system. The required blood pressure data is measured and transferred to the PulsioFlex Monitor that analyzes the data and calculates and displays the associated parameters." This confirms the algorithm (part of the software) operates in a standalone manner on the input data to calculate parameters.

7. The Type of Ground Truth Used

Based on the description of the device (hemodynamic monitoring using pulse contour analysis), the ground truth for validating its calculated parameters (like cardiac output) would typically be established using:

• Established gold standard measurement methods: For cardiac output, this often includes intermittent thermodilution (e.g., using the PiCCO module itself as a reference, or other established thermodilution techniques), or direct Fick method, although the document doesn't explicitly state the ground truth method used in the clinical data for the ProAQT component.
• The product description for the PiCCO Module does mention: "With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique." And for the ProAQT Sensor, it states: "Subscripts 'cal' and 'pc' are used to distinguish between different calibration methods for pulse contour analysis: 'pc': Calibration with CO from thermodilution; 'cal': Calibration with CO from user input using an external measurement method." This strongly implies that thermodilution or external measurement methods (like Doppler ultrasound technique, as mentioned for ProAQT calibration) were used as the ground truth or reference for calibrating and validating the continuous pulse contour derived cardiac output.

8. The Sample Size for the Training Set

The document does not provide information on a specific "training set" sample size. The device described appears to be based on established algorithms for pulse contour analysis, rather than a machine learning model that undergoes a distinct training phase. The software updates mentioned likely involve refinements to these algorithms rather than re-training a deep learning model.

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

As no specific "training set" or explicit machine learning model training is described, this information is not applicable/provided. The 'ground truth' for the development of such physiological algorithms would typically come from extensive physiological studies and comparisons to established measurement techniques, which are then encoded as deterministic algorithms within the software.

Ask a specific question about this device

The PulsioFlex Monitoring System is a diagnostic aid for the measurement and monitoring of blood pressure, cardiopulmonary, circulatory and organ function variables. The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient's data are entered, the PulsioFlex monitor presents the derived parameters indexed.

With the PiCCO Module cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. Both are used for the determination of other derived parameters.

With the CeVOX oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System measures continuous venous oxygen saturation to assess oxygen delivery and consumption.

The use of the PulsioFlex Monitoring System is indicated in patients where cardiovascular and organ monitoring is useful. This includes patients in surgical, medical, and other hospital units.

The PulsioFlex Monitoring System is a patient monitoring system that consists of the following components:
a) PulsioFlex Monitor
b) CeVOX Optical Module
c) PICCO Module

The PulsioFlex Monitor receives incoming signals from the patient through the connections with the modules and the accessories applied to the patient. The measurement hardware in the PulsioFlex Monitoring System provides the PulsioFlex host application (software) all data from the modules via USB protocol. The algorithms embedded in the monitor host application process the signals and provide parameter calculations. Based on the patient's biometric data, the PulsioFlex Monitor presents the derived parameters indexed.

The provided text is a 510(k) Premarket Notification for the PulsioFlex Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or a study solely proving the algorithm's performance.

Therefore, the information required to answer the prompt cannot be fully extracted from the provided text. The document states: "Clinical data was not required for this device." and the "Performance Data" section primarily addresses system verification, electrical safety, software verification, cybersecurity, and usability testing, all aimed at demonstrating that updates do not adversely affect safety and effectiveness compared to the predicate device.

Here's a breakdown of why each section of your request cannot be fully answered and what little information is available:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria for new derived parameters or overall device performance in the form of a table. Its focus is on showing equivalence for already cleared parameters and verifying the functionality of newly added derived parameters (GEF, CPO, PVPI, O2ER, and ITBV) which are calculated from previously cleared parameters. The performance data section refers to "measurements of Cardiac Output parameters and Oximetry parameters were performed with the subject device," but does not provide specific values or acceptance criteria for these measurements.

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

• Not applicable/Not provided. Since "Clinical data was not required," there isn't a test set of patient data in the typical sense for evaluating diagnostic accuracy or algorithm performance derived from patient outcomes. The "System Verification" describes testing "individual modules... at a system level," but this refers to technical verification, not a clinical data test set.

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):

• Not applicable/Not provided. As no clinical data test set was required or used for direct performance evaluation, there was no need for expert-established ground truth.

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

• Not applicable/Not provided. No clinical test set to adjudicate.

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:

• Not applicable/Not provided. This is not a study of AI assistance to human readers. It's a monitoring system that calculates physiological parameters.

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

• Partially applicable, but no detailed performance metrics. The document states that new derived parameters are "calculated by the PulsioFlex Monitors host application (software) based on the previous cleared parameters." This implies algorithm-only performance for these calculations. However, no specific performance metrics (e.g., accuracy against a gold standard for these calculated parameters) or a stand-alone study showing statistical results are provided. The "System Verification" section mentions "Measurements of Cardiac Output parameters and Oximetry parameters were performed with the subject device," but provides no details on the study design or results.

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

• Not explicitly stated for the "new derived parameters." Given that they are "calculated by the PulsioFlex Monitors host application (software) based on the previous cleared parameters," the implicit ground truth for the calculation logic would be physiological principles and mathematical correctness, likely verified through internal testing against known inputs and expected outputs, rather than clinical outcomes or expert consensus on raw patient data. For the original parameters, the ground truth would have been established during the predicate device's clearance.

8. The sample size for the training set:

• Not applicable/Not provided. This device is not described as being based on a machine learning model that requires a "training set" in the common sense (e.g., for image recognition). The "algorithms" mentioned process signals and calculate parameters, implying deterministic algorithms, not learned from a training dataset.

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

• Not applicable/Not provided. (See point 8).

In summary, the provided document is a regulatory submission for a device modification, demonstrating substantial equivalence. It does not contain the kind of detailed performance study data, acceptance criteria, ground truth establishment methods, or sample sizes related to clinical validation of AI algorithms or diagnostic accuracy that your prompt requests.

Ask a specific question about this device

The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.

The PULSION PulsioFlex Monitoring System with optional PiCCO Module is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVox oximetry module connected to a compatible oximetry probe, the PulsioFlex Monitoring System with PiCCO Module measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PulsioFlex Monitoring System measures heart rate, systolic, and diastolic and derives mean arterial and central venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PulsioFlex monitor presents the derived parameters indexed to body surface area.

The provided text describes the PulsioFlex Monitoring System with PiCCO Module and its intended use, along with a table of performance specifications. However, it does not contain details about a specific study proving the device meets its acceptance criteria, nor does it describe the methodology of such a study.

The table presented is a list of acceptance criteria (or "specifications" as labeled in the document) rather than a direct report of a study's results. The "Accuracy*" column states "Coefficient of variation ≤ 2%" or "+2%", which are the target performance metrics the device is expected to meet, not observed performance from a study. The "Remark" states "Statistical evaluation based on random examination of actual production output," which hints at some form of quality control or validation, but does not provide details of a formal study.

Therefore, many of the requested details cannot be extracted from the provided document.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides the acceptance criteria (specifications) for various parameters. It does not provide a separate column for "Reported Device Performance" from a dedicated study. The "Accuracy*" column represents the target criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any particular test set. The remark "Statistical evaluation based on random examination of actual production output" does not specify a sample size.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not mentioned or applicable. This device is a monitoring system for physiological variables, not an AI-assisted diagnostic tool for human readers.

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

• The device itself is a standalone monitoring system. The document lists its performance specifications, implying standalone performance. However, there is no detailed description of a "standalone study" with specified methodology.

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

• For physiological measurements like cardiac output, volumes, and oxygen saturation, ground truth would typically be established by validated reference methods or gold standards (e.g., direct Fick method, thermodilution from pulmonary artery catheter, blood gas analysis). The document does not specify how the accuracy was determined, only the target accuracy.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable in the context of this document. The device descriptions pertain to a physiological monitoring system and not a machine learning model that would require a "training set."

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.

PulsioFlex Monitoring System with Optional CeVox ™ Accessories

The provided text is a 510(k) premarket notification and does not contain detailed information about a study proving the device meets acceptance criteria. It mainly focuses on regulatory approval. Therefore, I cannot extract complete information for all the requested sections.

However, I can extract the acceptance criteria for oxygen saturation measurements from the "Indications for Use Statement" and state that no study details are provided in this document.

Here's what can be extracted:

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

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

Not provided in this document.

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)

Not provided in this document.

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

Not provided in this document.

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

Not applicable as this is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

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

This is a standalone device measuring oxygen saturation. The document doesn't provide performance data from any study, standalone or otherwise.

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

Not provided in this document. For oximetry, typically a co-oximeter is used as the reference standard (ground truth).

8. The sample size for the training set

Not applicable as this device is not described as having a training set (e.g., it is not an AI/ML model being trained).

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

Not applicable.

Ask a specific question about this device