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The Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters.

The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator.

The TFC contains software which runs on a separate computer and which is used to operate the device. This software includes a basic frontend (Task Force® CORE Viewer) as well as an interface for integration into other software products.

The TFC can provide all signals as well as measured and derived parameters to the analog output interface and can acquire signals from the analog input interface.

The medical device Task Force® CORE (TFC) with software version 1.0.7 is a new product, which is intended to be used in professional healthcare facilities and operated only by qualified healthcare professional staff, as described in the Indications for use.

The Task Force® CORE is intended to be used for the non-invasive continuous measurement of blood pressure and pulse rate, and the determination of associated derived hemodynamic parameters. . The principle of a continuous non-invasive measurement of a blood pressure is based on the Pénaz-Principle (vascular unloading).

The TFC consists of several components necessary for the intended operation:

• . Task Force® CORE Main Unit -TFC MU (see Figure 1) connected to an application computer via USB.
• . Applied parts (detachable components): CNAP® Classic Sensor Unit (see Figure 2) and TFC NBP Cuffs (see Figure 3)
• The TFC I/O Cable for using the Analog I/O interface (see Figure 4)
• Task Force® CORE Viewer as graphical user interface (see Figure 5) and TFC Driver, executed ● on an application computer (third - party manufacturer). Please note that the application computer is not a part of the subject device (SD) and therefore not within the scope of this submission.

Here's a breakdown of the acceptance criteria and the study details for the Task Force CORE device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Blood Pressure Measurement: 42 adult subjects (22 male, 20 female, age span 21 to 77 years).
• Cardiac Output Determination: 44 adult subjects (37 male, 7 female, age span 54 to 83 years).
• Inter-Beat-Interval and Pulse Rate Determination (Study 1): 44 adult subjects (22 male, 22 female, age span 21 to 77 years).
• Inter-Beat-Interval and Pulse Rate Determination (Study 2): 28 adult subjects (16 male, 12 female, age span 18 to 66 years).
• Data Provenance: The document does not explicitly state the country of origin or if the studies were retrospective or prospective. However, "Clinical performance studies" typically implies prospective data collection. The manufacturer is based in Graz, Austria, suggesting the studies likely occurred in Europe.

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

The document does not specify the number or qualifications of experts used to establish the ground truth beyond stating the "gold standard" references.

4. Adjudication Method for the Test Set:

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

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

No, an MRMC comparative effectiveness study was not done. The studies described are clinical performance studies comparing the device to gold standard reference methods, not human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, the clinical performance testing described focuses on the device's measurement performance against established "gold standard" reference methods. This indicates standalone (algorithm-only) performance, as it is evaluating the device's ability to accurately measure physiological parameters.

7. Type of Ground Truth Used:

• Blood Pressure Measurement: Invasive arterial reference (gold standard).
• Cardiac Output Determination: Thermodilution reference (gold standard).
• Inter-Beat-Interval and Pulse Rate Determinations: Electrocardiography (gold standard).

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. It focuses on the validation/test set for clinical performance.

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

Since there's no information on the training set sample size, there's also no information on how its ground truth was established.

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The CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals. The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters. Alarms are generated for blood pressure parameters and pulse rate. The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals.

The CNAP® Monitor 500 HD is a stand-alone device for continuous non-invasive blood pressure and hemodynamic monitoring with alarming functionality. The continuous non-invasive blood pressure is measured on the patient's finger using a double finger cuff, the oscillometric blood pressure measurement function (Advantage 2.0 OEM module by SunTech Inc.) is used for intermittent calibration of the continuous blood pressure curve. Medium priority alarming can be set for blood pressure beat values and pulse rate.

Based on the provided text, the CNAP® Monitor 500 HD is a blood pressure and hemodynamic monitoring system. The acceptance criteria and the study proving it meets these criteria are primarily focused on its substantial equivalence to predicate devices rather than independent performance metrics against a defined standard.

Here's the breakdown of the information provided, or lack thereof, regarding a detailed AI/algorithm study:

Key Observation: The document describes a medical device, not an AI/ML algorithm. The performance data section focuses on electrical safety, electromagnetic compatibility, mechanical and acoustical testing, and software verification/validation, along with a claim of substantial equivalence to predicate devices based on clinical testing using "measurement data from different sources." There is no indication of an AI/ML algorithm being developed or studied for this device, nor is there a study described that would fit the typical criteria for AI/ML performance evaluation (e.g., sensitivity, specificity, AUC, human reader improvement studies).

Therefore, I will answer the questions based on the closest relevant information provided, while highlighting where the requested details for an AI/ML study are not applicable or not present in the document.

Acceptance Criteria and Device Performance (based on provided text)

The document focuses on demonstrating substantial equivalence to predicate devices. This is the primary "acceptance criterion" from a regulatory perspective. The performance data presented are primarily related to safety, electromagnetic compatibility, and software verification rather than specific diagnostic accuracy metrics for an AI.

Given the nature of the device (a non-invasive blood pressure and hemodynamic monitor), the key performance "acceptance" would be its accuracy in measuring blood pressure and derived hemodynamic parameters, and its safety. However, the document does not provide a table of precise acceptance criteria with numeric targets (e.g., ±5 mmHg for BP accuracy) or how the specific device performance was measured against such targets for the new device. Instead, it relies on demonstrating comparable performance to predicate devices.

Table of Acceptance "Criteria" (based on regulatory submission principles for this device type) and Reported Device "Performance":

Details Specific to AI/ML Studies (Not Applicable or Not Provided)

1. Sample sizes used for the test set and the data provenance:

   • The document states "For clinical testing and evaluation measurement data from different sources was used to demonstrate that the device is substantially equivalent to the predicate devices."
   • No specific sample size for a "test set" (as understood in AI/ML validation) is provided.
   • No data provenance (e.g., country of origin, retrospective/prospective) is specified for this "measurement data." This is typical for a traditional medical device submission focused on equivalence, rather than a novel AI algorithm.

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

   • Not applicable / Not provided. The device is a monitor that directly measures/derives physiological parameters, not an diagnostic imaging AI that requires expert labeling for ground truth. Ground truth for blood pressure and hemodynamic parameters in a device like this would typically involve invasive measurements (e.g., arterial line for BP) or established reference methods, not expert consensus on image labels. The document does not describe how this "measurement data" was validated against a gold standard.

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

   • Not applicable / Not provided. This method is relevant for studies involving human interpretation or labeling of data, especially in AI development for image analysis or diagnostics. It does not apply to a physiological monitoring device undergoing substantial equivalence testing.

4. 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 done. An MRMC study is specific to AI-assisted diagnostic tools where human interpretation is part of the workflow. This device is a physiological monitor, not an AI that assists human readers.

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

   • Not applicable / Not explicitly detailed as an AI algorithm study. The device itself is a "standalone" monitor that performs continuous non-invasive blood pressure and hemodynamic monitoring. The "performance data" section broadly covers its functional performance, but not in the context of an isolated AI algorithm. The device's "algorithms" are for signal processing and calculation of physiological parameters, which are validated as part of the overall device functionality, not typically as distinct "standalone AI" studies in the regulatory sense described.

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

   • Not explicitly stated in detail. For a non-invasive blood pressure device, the gold standard (ground truth) is typically invasive arterial blood pressure monitoring. For hemodynamic parameters, it would be direct measurement methods like thermodilution (e.g., using a Swan-Ganz catheter). The document only generically refers to "measurement data from different sources."

7. The sample size for the training set:

   • Not applicable / Not provided. This device is not described as involving a machine learning model that would require a distinct "training set" for its primary function. While there might be internal development data used to optimize signal processing algorithms, it is not presented as an AI/ML training regimen.

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

   • Not applicable / Not provided. As no AI/ML training set is described, this question is not relevant to the provided text.

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The Task Force® Monitor 3040 (TFM) is intended to noninvasively measure and display a patient's hemodynamic parameters using Impedance Cardiography (ICG), Electrocardiography (ECG), and photoplethysmography (continuous), oscillometric Blood Pressure (oscBP) and continuous blood pressure. The TFM continuously monitors the subject's hemodynamic parameters without reporting any diagnosis. Every measurement must be supervised by a medical trained professional. The Task Force® Monitor 3040 is a diagnoses aiding device and therefore not designed for vital sign monitoring or self-monitoring of patients.

The device architecture of the TFM is equivalent to the BioZ.pc. The TFM system consists of a Patient Biosignal Electronic System (PBES) and a PC for calculating and displaying the hemodynamic parameters. ICG signals from a patient are assessed using the same method as the predicate device (8 electrodes, injecting a minimal current). The user inputs the patient's data into the TFM software on the PC including gender, age, height, weight, hematocrit and the distance between the inner ICG electrodes. The PC runs Windows 2000 operating system. The parameters are displayed on a full color screen and measurement data can be stored on the PC's hard disk. The TFM calculates and displays the same hemodynamic parameters as the predicate device.

Here's a breakdown of the acceptance criteria and study information for the CNSystems Task Force® Monitor 3040, based on the provided text:

Acceptance Criteria and Reported Device Performance

The documents primarily focus on demonstrating substantial equivalence to predicate devices rather than directly stating specific acceptance criteria with quantified performance targets for the Task Force® Monitor 3040 itself. Instead, the performance specifications of the TFM are compared against its predicate devices.

However, based on the "Performance specification" section, we can infer the following:

Study Information

1. Sample Size used for the test set and the data provenance:

   • The document mentions "A clinical study shows, that both devices follow the arterial blood pressure very well with the difference, that the TFM has no interruptions in the signal." However, no specific sample size for this clinical study is provided.
   • Data provenance is not explicitly stated. Given the manufacturer is CNSystems Medizintechnik GmbH in Austria, it is likely the study was conducted in Europe, possibly Austria, but this is an inference. It's also not stated if the study was retrospective or prospective.

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

   • Not specified. The document does not provide details on the establishment of ground truth or the involvement of experts for the clinical study mentioned.

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

   • Not specified. There is no mention of an adjudication process for the clinical study.

4. 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 comparative effectiveness study involving human readers and AI assistance was not mentioned. The document describes a comparison between the new device (Task Force® Monitor 3040) and two predicate devices, not a study comparing human performance with and without AI assistance. The TFM is a measurement device, not an AI-assisted diagnostic tool in the typical sense implied by an MRMC study.

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

   • The primary study mentioned is a "clinical study" comparing the TFM and the Finapres device's blood pressure measurement. This suggests a standalone performance evaluation of the device's measurement capabilities. The device is intended "to noninvasively measure and display a patient's hemodynamic parameters" and states "Every measurement must be supervised by a medical trained professional." This implies it's a device that provides data to a professional, rather than an "algorithm only" in the sense of a fully automated diagnostic AI. The "standalone" performance here refers to the accuracy of its measurements against a reference.

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

   • For the clinical study, the ground truth for comparing continuous blood pressure is implied to be through direct comparison with the Finapres device and its established methods, and the TFM uses an oscillometric device for "absolute BP values." Therefore, the ground truth is likely based on established physiological measurement techniques, with the oscillometric device serving as a reference for absolute BP values.

7. The sample size for the training set:

   • Not applicable / Not specified. The document does not describe the Task Force® Monitor 3040 as an AI-driven device requiring a training set in the modern sense. It uses "methods and algorithms for calculating the patient's hemodynamic parameters as both predicate devices." The development would have been based on physiological principles and existing algorithms rather than machine learning training on a large dataset.

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

   • Not applicable / Not specified. As the device is not described as based on machine learning, there is no mention of a training set or ground truth establishment for it. Its validation is based on demonstrating substantial equivalence to predicate devices using established measurement principles.

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