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The BMEYE CC Nexfin is intended to, non-invasively and continuously, measure blood pressure, hemodynamic parameters, functional saturation of arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult patients. The pulse-oximetry component of CC Nexfin is indicated for use during both no motion and motion conditions and for patients who are well or poorly perfused. The CC Nexfin monitor does not feature (physiological) alarms, therefore the continuous availability of pulse-oximetry data should be treated as a series of spot-checks rather than continuous monitoring. The CC Nexfin monitor should be calibrated with a thermodilution measurement, or other accurate reference estimation of cardiac output, to ensure optimal accuracy of cardiac output. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

The BMEYE CC Nexfin hemodynamic monitor 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) and heart rate as well as a Cardiac Output (CO), which is derived, non-invasively, from the blood pressure waveform. The monitor also calculates derived hemodynamic parameters. The operation of the blood pressure and cardiac output measurement is identical to the operation in Nexfin Model 1 (K072049).

The CC Nexfin enables in addition the simultaneous measurement of SpO2 and SpHb using a pulse-CO oximetry sensor. The Nexfin Model 2 is to be used in combination with Masimo oximetry sensors. (K090238)

The provided document focuses on the 510(k) summary for the Nexfin Model 2 (trade name CC Nexfin) and primarily discusses its substantial equivalence to predicate devices, safety testing, and intended use. It does not contain details about specific acceptance criteria, a standalone study proving performance, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies for this particular device.

The document mentions functional and clinical testing for the predicate device (Nexfin Model 1) for Cardiac Output and NBP functionality, but it does not present the specific results or acceptance criteria for those tests. It merely states that the CC Nexfin has successfully undergone safety and functional testing.

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

Here is a summary of the available information:

1. Acceptance Criteria and Reported Device Performance

The document states that the CC Nexfin has "successfully undergone safety testing as well as functional testing to demonstrate equivalence to its predicate devices." However, it does not provide a table of specific acceptance criteria or reported device performance metrics for these tests. The conclusion is a general statement that "The results of this testing demonstrates that the device is safe and effective and substantially equivalent to its predicate device."

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

Not provided in the document.

The document mentions "Clinical Testing (for NBP functionality, in Nexfin Model 1)" but does not specify the sample size or data provenance for this testing.

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

Not provided in the document.

4. Adjudication Method for the Test Set

Not provided in the document.

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

No, an MRMC study is not mentioned. The document focuses on showing substantial equivalence to predicate devices through functional and safety testing, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document implies standalone testing for the device's functional aspects, stating "Functional Testing" and "Bench Testing (for Cardiac Output functionality in Nexfin Model 1)" as part of the quality assurance measures. However, no specific details about the standalone performance metrics, experimental setup, or results are provided for the CC Nexfin.

7. The Type of Ground Truth Used

For the predicate device, "Bench Testing (for Cardiac Output functionality in Nexfin Model 1)" and "Clinical Testing (for NBP functionality, in Nexfin Model 1)" are mentioned. This suggests that reference measurements (likely from other established devices or clinical procedures) were used as ground truth for these functionalities. For the SpO2 and SpHb functions, it states "H/W and S/W Implementation Verification Testing of the SpO2 and SpHb functions by Masimo," implying validation against Masimo's established standards or reference methods. The document does not explicitly state the specific type of ground truth (e.g., pathology, outcomes data).

8. The Sample Size for the Training Set

Not applicable. This device is a hemodynamic monitor, not an AI/machine learning device that would typically have a "training set" in the conventional sense of algorithm development. The document describes it as employing "identical technology for blood pressure and cardiac output measurement as was implemented in the predicate device (Nexfin Model 1)" and using "the Masimo Rainbow SET technology for the measurement of SpHb and SpO2."

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

In summary, the provided text serves as a 510(k) summary for regulatory clearance, focusing on substantial equivalence and general safety/effectiveness. It does not contain the detailed study information sought for acceptance criteria, performance metrics, and study design elements like sample sizes, expert qualifications, or adjudication methods.

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The BMEYE NEXFIN_HD is intended to, non-invasively and continuously, measure blood pressure and hemodynamic parameters in adult patients. The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

The BMEYE NEXFIN_HD cardiovascular monitor is a non-invasive monitor that enables the continuous assessment of a patient's cardiovascular function based on the scientific method of Peňáz - Wesseling.

The NEXFIN_HD measures continuous non-invasive blood pressure (Systolic, Diastolic and Mean) and heart rate as well as a Cardiac Output (CO), which is derived, non-invasively, from the blood pressure waveform. The monitor also calculates derived hemodynamic parameters.

The provided text is a 510(k) summary for the NEXFIN_HD Continuous Non-Invasive Hemodynamic Monitor. It focuses on establishing substantial equivalence to a predicate device (Finometer K023723) through functional and safety testing, rather than an AI-based performance study with specific acceptance criteria and ground truth for an algorithm.

Therefore, many of the requested categories for a study proving device acceptance criteria in an AI context are not applicable or cannot be extracted from this document, as the device described is a hardware medical device with embedded functional technology, not an AI/ML algorithm.

Here's an attempt to address the request based on the available information:

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

The document does not specify quantitative acceptance criteria in numerical thresholds for performance metrics for the NEXFIN_HD versus a reference or ground truth. Instead, the "acceptance criteria" are implied by the successful completion of various tests to demonstrate safety, effectiveness, and substantial equivalence to the 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):

• Sample Size for Test Set: The document mentions "Clinical Testing (for NBP functionality)" but does not specify the sample size used for this clinical testing.
• Data Provenance: Not specified. It's likely prospective for clinical testing, but the location is not mentioned.

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 as this is a functional/measurement device, not an AI-driven diagnostic or interpretative device where expert-established ground truth would be relevant in the way this question implies. Ground truth for blood pressure and hemodynamic parameters would typically come from other validated medical devices or established physiological measurements (e.g., thermodilution for cardiac output, invasive arterial line for blood pressure).

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

Not applicable for a functional medical device as described.

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. This device is a measurement tool, not an AI-assisted diagnostic tool that would involve human "readers."

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

Not applicable in the context of an AI algorithm. The device itself is a standalone monitor.

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

The document states: "The NEXFIN_HD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy." This strongly suggests that a gold standard for Cardiac Output (like thermodilution) was used as a reference (ground truth) during testing or for calibration. For Blood Pressure (NBP), it would typically be compared against another validated NBP device or an invasive arterial line.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that undergoes a training phase with a specific dataset.

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

Not applicable.

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