(265 days)
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"):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional and Technical | - Visual, dimensional, and handling tests passed |
| - Lifetime test passed | |
| - Verification of required product characteristics confirmed | |
| - Tests according to ISO 594-1:1986 and ISO 594-2:1998 requirements passed | |
| - Tests according to ANSI/AAMI BP22 requirements passed | |
| - Tests according to ISO 11607-1 requirements passed | |
| Software Performance | - Software updated to V5.2, adaptations for cardiac output calibration with ProAQT Sensor verified. |
| - Performance and compatibility of ProAQT Sensor with PulsioFlex Monitor successfully verified. | |
| - Software verification performed according to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and IEC 62304. | |
| Electrical Safety & EMC | - Compliance with IEC 60601-1 (with US deviation), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 62366-1, IEC 60601-2-34, and IEC 60601-2-49 standards. |
| Sterilization Validation | - Sterility assured by EO sterilization to a minimum Sterility Assurance Level (SAL) of 10^-6. |
| - Validated according to ISO 11135 requirements and revalidated according to ISO 11135:2014. | |
| - Residuals evaluated by exhaustive extraction according to ISO 10993-7:2009. | |
| Biocompatibility | - Evaluation conducted in accordance with ISO 10993-1. |
| - Toxicological endpoints (Cytotoxicity, Sensitization, Intracutaneous Reactivity/Irritation, Acute Systemic Toxicity, Material-mediated Pyrogenicity, Subacute/Subchronic Toxicity, Hemocompatibility) considered. | |
| Shelf-Life | - 36 months (3 years) shelf life demonstrated through accelerated and real-time aging, with data from 18 and 36-month increments confirming the requirement. |
| Usability | - Summative Usability Evaluation performed according to FDA's "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366-1. The device found safe and effective for intended users, uses, and environments. |
| Clinical Performance (Pulse Contour Algorithm) | - Clinical data demonstrates the pulse contour algorithm is able to process pressure signals adequately from femoral, brachial, axillary, and radial arteries. |
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.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).