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The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS).

Cardiac output derived from the flow signal requires a calibration with thermal dilution.

The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.

When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.

When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.

When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.

The Finapres NOVA is intended to be used for subjects above 18 years of age.

The Finapres NOVA is intended for use in hospitals, clinics, and research centers.

The Finapres NOVA with FEU NC is based on existing Finapres Medical Systems B.V. product: the Finapres Nova. The current hardware that generates pressure in the Finapres NOVA contains components which are end-of-life. Therefore, they will need to be replaced. It was decided not to redesign these PCBs, but to redesign the whole pressure control hardware for reasons mentioned below.

In the new NOVA with FEU NC, the wrist unit FEU of the current NOVA system is replaced by the wrist unit FEU Nano Core. The FEU Nano Core wrist unit has the capability of generating pressure in the wrist unit, whereas with the FEU wrist unit the pressure was generated in the NOVA base station. This means that the pump, printed circuit boards (PCBs) and FEU have been replaced by a new power supply PCB and the FEU NC. By moving the pressure generation and control to the Nano Core wrist unit, there is no need for a pressure cable from the base station to the wrist unit anymore, which increases the mobility of the system and patient.

Here's a breakdown of the acceptance criteria and study information for the Finapres NOVA with FEU NC, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) pertains to changes made to an already cleared device, the Finapres NOVA (predicates K141460 and K160967). The primary acceptance criterion for this submission is substantial equivalence to the predicate devices, with specific emphasis on ensuring that the changes to the pressure generation mechanism do not negatively impact the blood pressure measurement accuracy. The clinical performance criterion is adherence to a recognized standard for non-invasive blood pressure measurement devices.

2. Sample Size for Test Set and Data Provenance

The document states:

• Clinical Investigation: "A clinical investigation was performed according to the requirement of ISO 81060-2:2013 which proves the Finapres NOVA with FEU NC meets the accuracy requirement regarding blood pressure measurements of this standard." Specific sample size is not explicitly mentioned in the provided text for the clinical study.
• Benchtop Testing (Hemodynamic Parameter Validation): "99 measurements" were performed using "7 different simulator models."
• Data Provenance: The document does not explicitly state the country of origin for the clinical or bench data. Given the "Finapres Medical Systems B.V." address in "Enschede, The Netherlands," it is highly probable the studies were conducted in the Netherlands or Europe. The studies appear to be prospective as they were conducted to validate the new FEU NC.

3. Number of Experts and Qualifications for Ground Truth

• Clinical Study (ISO 81060-2:2013): For clinical blood pressure accuracy studies conforming to ISO 81060-2, human reference measurements are typically obtained by trained operators, often in a double-blinded fashion. However, the exact number of experts and their specific qualifications beyond adherence to the standard's protocol are not explicitly detailed in this summary. The standard generally requires two observers to perform auscultatory measurements against a reference.
• Benchtop Testing: Ground truth for benchtop tests would be established by the highly accurate pressure and flow measurements from the finger simulator, as described. The "experts" in this context would be the engineers and scientists developing and operating this simulator.

4. Adjudication Method for the Test Set

• For the clinical investigation conforming to ISO 81060-2:2013, the standard dictates specific methods for averaging and comparing test device measurements against reference measurements obtained by observers. This usually involves multiple measurements per subject and statistical analysis to determine accuracy and precision. While not explicitly stated as "2+1" or "3+1", the standard's methodology implicitly handles potential discrepancies by requiring a certain number of qualified observers and statistical criteria.
• For benchtop testing, the "adjudication" would be based on the direct comparison of the device's output to the highly accurate simulator measurements.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This device is a monitor, not an AI interpretation system for diagnostic images or complex data, so an MRMC study would generally not be applicable.

6. Standalone (Algorithm Only) Performance Study

The document describes both bench testing and a clinical investigation focused on the performance of the Finapres NOVA with FEU NC.

• Bench testing "performed a technical bench validation test in which the pressure generation and registration of the predicate system NOVA and the NOVA with FEU NC are compared." This can be considered a standalone performance evaluation of the technical components and algorithms within a controlled environment.
• The clinical investigation evaluates the "algorithm only" (as embedded in the device's functionality) in real-world clinical settings, comparing its output to a reference standard (invasive blood pressure, implicitly, as per typical ISO 81060-2 studies).

7. Type of Ground Truth Used

• Clinical Investigation: The ground truth for blood pressure measurements would be derived from a reference method for blood pressure, typically invasive intra-arterial blood pressure measurements or a highly accurate sphygmomanometer as dictated by ISO 81060-2:2013 for non-invasive blood pressure devices. The document explicitly states "BP(intra-arterial) Does conform to IEC 81060-2:2009 and AAMI SP10 :2002 after calibration" and that "clinical data was also used to calculate the hemodynamic parameters based on both the invasive reference and K173916." This strongly suggests invasive reference measurements were used for comparative ground truth.
• Benchtop Testing: The ground truth for hemodynamic parameter validation was established by a finger simulator capable of mimicking blood pressure waveforms and providing highly accurate reference values for comparison.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. Given this is a 510(k) for a device modification (change in hardware components, FEU NC), and the algorithms are stated to be "the same as used in the secondary predicated," it implies that the core algorithms were developed and "trained" (if machine learning was involved, which is not indicated for the primary blood pressure algorithm) during the development of the predicate devices (K141460 and K160967). The current submission focuses on validation of the modified device against established standards, not on new algorithm development requiring a distinct training set. The "software performance" was established "consistent with moderate level of concern," implying verification and validation of existing code.

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

As mentioned above, a specific "training set" for new algorithm development is not described. The existing algorithms from the predicate devices were "copied and translated into a new programming language" and their functionality maintained. The ground truth for the original development of these algorithms (J. Peñáz volume-clamp method and K.H. Wesseling Physiocal criteria) would have been established through extensive physiological research and clinical studies over many years. For the current submission, the focus is on maintaining the established performance of these algorithms despite hardware changes, which is assessed via the validation studies.

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The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution.

The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.

When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.

When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.

When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.

The Finapres NOVA is intended to be used for subjects above 18 years of age.

The Finapres NOVA is intended for use in hospitals, clinics and research institutions.

The Finapres NOVA is an instrument to noninvasively monitor blood pressure and hemodynamic parameters. The Finapres NOVA provides a characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals.

The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device.

The measurement of blood pressure in a finger is based on the arterial volume-clamp method of the Czech physiologist J. Peñáz, and the Physiocal - physiological calibration criteria for the proper unloading of the finger arteries of K.H. Wesseling. With this method, finger arterial pressure is measured using a finger cuff and an inflatable bladder in combination with an infrared plethysmograph, which consists of an infrared light source and detector.

The SpO2, upper arm calibration and ECG modules used in the Finapres NOVA are commercially available OEM modules that are used in FDA approved systems. The finger blood pressure measurement module used in the system is similar to other Finapres Medical Systems B.V. devices available on the market. The analog input/output module has been developed by Finapres during the Finapres NOVA development.

The embedded software in the device provides computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the non-invasely measured blood pressure waveform. Hemodynamic parameters include cardiac output based on the modelflow method and total peripheral resistance.

The addition to the Finapres NOVA software covered in this application is mostly related to the addition of a software module called ANS (Autonomous Nervous System). (Para)sympathetic function can be assessed by a physician through arterial Baro Reflex Sensitivity (BRS) testing and Heart Rate Variability (HRV) analysis. The ANS software module calculates additional parameters, derived from pressure and ECG signals measured with the Finapres NOVA, which are related to Baro Reflex Sensitivity and to Heart Rate Variability.

A baroreceptor is a sensory nerve ending in de wall of the aortic arch and carotid bulbus that is sensitive to changes in blood pressure. These baroreceptors act as receptors of central reflex mechanisms that regulate the blood pressure. The blood pressure is regulated by altering heart rate (baroreflex), cardiac contractility, vasoactivity and humoral activity. The main function of the baroreflex is to maintain a stable blood pressure. To quantify whether the baroreflex is functioning properly the linear regression line of the relation between systolic blood pressure and resulting interbeat interval is estimated. The slope of this linear regression line is defined as the Baro Reflex Sensitivity (BRS) and is to be used in the assessment of the (dys)function of the baroreflex.

Heart rate variability (HRV) is the physiological phenomenon of variation in the time interval between heartbeats. It is determined using the beat-to-beat interval.

Using this additional software module, the Finapres NOVA only presents parameters derived from the interbeat interval (HRV) and blood pressure (BRS) to the user. It is up to the user to draw conclusions on whether these values are normal or abnormal.

The additional Remote Control Module provides the possibility to monitor and control a Finapres Nova from a PC. This can be achieved by establishing a network connection from a PC to the Finapres Nova. Two types of connections can be made: one that is restricted to viewing and one that allows full control of the Finapres Nova.

The additional Nova Scope PC application is used to view and review measurement files recorded with the Finapres Nova on a PC instead of on the NOVA instrument itself.

Here's an analysis of the acceptance criteria and study information for the Finapres NOVA Noninvasive Hemodynamic Monitor, based on the provided text.

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a new clinical study with specific acceptance criteria and detailed performance metrics of the device as a standalone product. Therefore, some of the requested information (like specific quantitative acceptance criteria for this device and a detailed study proving this device meets those criteria) is not explicitly present in the format typically found in a full clinical trial report. Instead, the document focuses on demonstrating that the new software module (ANS) performs equivalently to algorithms in a predicate device.

Acceptance Criteria and Study Information for Finapres NOVA Noninvasive Hemodynamic Monitor (ANS software module)

This document describes the 510(k) submission for the addition of an Autonomic Nervous System (ANS) software module to the Finapres NOVA, along with a Remote Control module and Nova Scope PC application. The core of the submission for the ANS module is demonstrating substantial equivalence to the algorithms in a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific quantitative acceptance criteria for the Finapres NOVA's ANS module's performance metrics (e.g., specific accuracy thresholds for HRV or BRS values). Instead, the acceptance criterion for the ANS module's performance was to be substantially equivalent to the performance of the algorithms in the secondary predicate device, the TASK FORCE MONITOR 3040.

2. Sample Size Used, Test Set, and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions that "The performance of the HRV and BRS algorithm was tested," implying a test set was used, but the size of this set (number of patients/cases) is not provided.
• Data Provenance: Not explicitly stated for the algorithm performance test. The device is manufactured by Finapres Medical Systems B.V. in the Netherlands. The predicate device (TASK FORCE MONITOR 3040) is from CNSYSTEMS MEDIZINTECHNIK GMBH, Graz, Austria. Without a direct statement, it's unclear if the test data for the algorithm comparison was retrospective or prospective, or its geographic origin.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The document focuses on demonstrating substantial equivalence of algorithms to a predicate device's algorithms, not on establishing a physician-adjudicated ground truth for a novel diagnostic claim requiring expert consensus. The "ground truth" for the algorithm comparison would be the output of the predicate device's algorithms or a reference standard used in its validation.

4. Adjudication Method

• Not applicable. See point 3.

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

• No, an MRMC comparative effectiveness study was not done. The submission primarily focuses on the technical and algorithmic equivalence of the ANS software module to a predicate device's algorithms. There is no mention of a study involving human readers or comparing their performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance assessment of the algorithm was conducted, implicitly. The statement "The performance of the HRV and BRS algorithm was tested and found to be substantially equivalent with the performance of the algorithms of our secondary predicate device, the TASK FORCE MONITOR 3040" indicates that the algorithm's output was directly compared to the predicate device's algorithm output. This represents an algorithm-to-algorithm comparison, which is a form of standalone evaluation in this context of substantial equivalence for a software module.

7. Type of Ground Truth Used

• Predicate device algorithm output / Reference Standard from Predicate. The "ground truth" in this context refers to the established and validated performance of the algorithms within the predicate device (TASK FORCE MONITOR 3040), or a recognized reference standard that the predicate device's algorithms were validated against for HRV and BRS. The document does not specify how the predicate device's algorithms were validated, but for the purpose of this 510(k), the predicate's performance serves as the benchmark.

8. Sample Size for Training Set

• Not explicitly stated, and likely not applicable in the traditional sense for this submission. This submission is for a new software module being added to an existing device (Finapres NOVA cleared under K141460). The focus is on the performance of the new ANS algorithms compared to a predicate, not on training a new machine learning model from scratch that would require a distinct training set. The algorithms for HRV and BRS are likely established physiological models rather than data-driven machine learning models requiring large-scale training sets in the same way.

9. How Ground Truth for Training Set Was Established

• Not applicable. See point 8.

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The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. Cardiac output derived from the flow signal requires a calibration with thermal dilution.

The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration.

When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate.

When the ECG module is present, the Finapes NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor.

When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration.

The Finapres NOVA is intended to be used for subjects above 18 years of age.

The Finapres NOVA is intended for use in a professional medical environment.

The Finapres NOVA is an instrument to noninvasively monitor blood pressure and hemodynamic parameters. The Finapres NOVA provides a characterization of the arterial circulation and its beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. The Finapres NOVA has the option to include four additional modules to extend its functionality with ECG and SpO2 measurements, blood pressure calibration and data transfer to and from the device.

The embedded software in the device provides computation of real-time and beat-tobeat blood pressure as well as hemodynamic parameters from the non-invasely measured blood pressure waveform. Hemodynamic parameters include cardiac output based on the modelflow method and total peripheral resistance.

The measurement of blood pressure in a finger is based on the arterial volume-clamp method of the Czech physiologist J. Peñáz, and the Physiocal - physiological calibration criteria for the proper unloading of the finger arteries of K.H. Wesseling. With this method, finger arterial pressure is measured using a finger cuff and an inflatable bladder in combination with an infrared plethysmograph, which consists of an infrared light source and detector.

The SpO2, upper arm calibration and ECG modules used in the Finapres NOVA are commercially available OEM modules that are used in FDA approved systems. The finger blood pressure measurement module used in the system is similar to other Finapres Medical Systems B.V. devices available on the market. The analog input/output module has been developed by Finapres during the Finapres NOVA development.

The provided text describes the Finapres NOVA device and its substantial equivalence determination. However, it does not contain the specific information required to complete all sections of your request, particularly regarding detailed acceptance criteria testing and clinical performance studies as you've outlined.

The document explicitly states: "Clinical performance data was not required to demonstrate substantial equivalence." This means that a specific clinical study with acceptance criteria for the Finapres NOVA's performance (e.g., accuracy against a gold standard in a human population) was not conducted or presented in this 510(k) summary.

Instead, the submission relies on non-clinical performance data by testing the device against various medical device safety and performance standards (listed in Table 3 in the document) and by demonstrating substantial equivalence to predicate devices that have already been cleared.

Here's a breakdown of what can and cannot be answered from the provided text:

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

The document lists numerous standards that the Finapres NOVA was tested against (Table 3), indicating that compliance with these standards serves as the "acceptance criteria" for non-clinical performance. However, it does not provide specific numerical values for acceptance criteria or reported device performance for blood pressure accuracy (e.g., Mean Difference, Standard Deviation as per AAMI SP10 or ISO 81060-2:2009 for the Finapres NOVA itself). It only states that the device "met all applicable requirements."

The document mentions compliance with "AAMI SP10:2002 and its successor IEC 81060-2:2009" for blood pressure calibration, but it does not present the direct results of such a clinical validation for the Finapres NOVA. It implies that the ability to be calibrated allows for accurate data, rather than directly presenting the Finapres NOVA's accuracy results against those standards.

Therefore, a table with specific numerical acceptance criteria and reported performance cannot be fully constructed directly from this document for the Finapres NOVA's clinical accuracy.

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

Since clinical performance data was explicitly "not required to demonstrate substantial equivalence" for the Finapres NOVA device itself, there is no test set sample size or data provenance provided for a clinical study of the Finapres NOVA.

The non-clinical performance testing against standards doesn't typically involve a "test set" in the sense of clinical data from patients.

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

Not applicable, as no clinical test set for the Finapres NOVA's performance is described.

4. Adjudication method for the test set

Not applicable, as no clinical test set for the Finapres NOVA's performance is 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. The Finapres NOVA is a non-invasive blood pressure and hemodynamic monitor, not an AI-assisted diagnostic tool that would involve "human readers" or "AI assistance" in the context of interpretation.

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

The Finapres NOVA is described as a standalone device with embedded software that computes real-time blood pressure and hemodynamic parameters. Therefore, its "standalone" performance is implicitly what the non-clinical testing against standards evaluated. However, specific performance metrics for the algorithm itself (e.g., accuracy of cardiac output calculation against a gold standard) are not provided in numerical detail.

7. The type of ground truth used

For the non-clinical performance testing, the "ground truth" would be established by the specifications and measurement methods defined within the various international standards the device was tested against (e.g., IEC, ISO, AAMI standards for electrical safety, EMC, basic safety, essential performance, and specific requirements for sphygmomanometers, oximeters, and ECG equipment).

The document mentions: "Cardiac output derived from the flow signal requires a calibration with thermal dilution." This implies that for cardiac output measurements, thermal dilution is the clinical "gold standard" or "ground truth" for calibration. However, it's not stated that the Finapres NOVA's cardiac output was validated against this in a clinical study presented here.

8. The sample size for the training set

Not applicable. This device is not described as involving a machine learning or AI algorithm that requires a "training set" in the conventional sense for image analysis or classification. Its embedded software is based on established physiological models (e.g., arterial volume-clamp method, Modelflow method).

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

Not applicable, as there's no machine learning "training set" described.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence primarily through non-clinical performance data (compliance with device standards) and comparison to predicate devices, rather than through a new clinical study with specific performance acceptance criteria for the Finapres NOVA itself.

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