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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.

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