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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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The Finometer is intended to be used when there is a need for a noninvasive hemodynamic monitor. The Finometer provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow as well as in various hemodynamic parameters derived from these pressure and flow signals. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

The noninvasively blood pressure waveform is measured by using the Finapres method of Peñáz/Wesseling. Hemodynamic parameters include cardiac output and total peripheral resistance based on the Modelflow method of Wesseling.

The Finometer is intended to be installed and operated by a qualified physician or operator. Pressure measurements are validated for subjects above 18 years of age. The only mode of measuring blood pressure accurately is when the device is used with the return-to-flow method of calibration, if the pressure data are to comply with the recommendations of the AAMI SP10 standard.

Modelflow built-in calibration is useful from 18 years on. Cardiac output measured with this device under the Modelflow model requires a calibration with thermal dilution.

The physiological parameters provided by the device have clinical significance only if determined by a physician and should not be used as the sole means for a patient's diagnosis.

The data provided by the device can be further processed by the included PC-based BeatScope software.

The Finometer Noninvasive Hemodynamic Monitor is a stationary device to record continuous noninvasive arterial blood pressure as well as additional hemodynamic parameters.

The Finometer is a stationary device. It consists of the Main Control Unit with electronics and a solidstate disk for storage. The Main Control Unit also contains the two pressurized air circuits, including air pumps, for the measurements using the Finapres methodology and for the RTF calibration methodology. A Frontend Unit is used to provide an interface for the electronic signals from the Main Control Unit electronics and air supply to the forger cuffs, an arm cuff, and an analog input/output unit. The Frontend Unit connects the Main Control Unit to the forger cuff, which in turn consists of an inflatable air bladder and an infrared photoplethysmograph

The Main Control Unit microprocessor has an internal solid-state disk storing up to 24 hours of continuous blood pressure and derived hemodynamic data. The Main Control Unit is equipped with an RS232 serial interface to transfer the data stored in the Finometer disk to a PC and to allow remote control of the Finometer.

The analog input/output unit provides four analog signal outputs for connection to other data acquisition systems, and provides three analog signal inputs for sampling and storing of external signals simultaneously with the Finometer data. An external (intra-arterial) blood pressure signal can be used to replace the finger blood pressure. The Finometer then will use the external pressure signal to derive all parameters.

BeatScope PC-software is also delivered with the Finometer to enable downloading, viewing, and further handling of Finometer data. BeatScope provides the capability of on-line monitoring, storage, and limited control of a Finometer measurement on a remote PC.

The provided text is a 510(k) summary for the FMS Finometer Noninvasive Hemodynamic Monitor. It focuses on establishing substantial equivalence to predicate devices and describes the device's intended use and technological characteristics.

Crucially, the document does NOT contain a study proving the device meets specific acceptance criteria. It states, "No new technology, materials, or change in efficacy have been introduced by FMS in the manufacture of the FMS Finometer Noninvasive Hemodynamic Monitor." This implies reliance on the predicate devices' established performance rather than a new effectiveness study for this specific 510(k) submission.

Therefore, I cannot fulfill most of your request for information related to an acceptance criteria study. However, I can extract what is mentioned about performance and relevant details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions compliance with the AAMI SP10 standard for blood pressure data when using the return-to-flow calibration method. It also states that pressure measurements are "validated for subjects above 18 years of age." However, specific numerical acceptance criteria (e.g., mean difference, standard deviation) from a performance study are not provided.

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

Not applicable. The 510(k) does not describe a new performance study with a test set. It relies on the substantial equivalence to predicate devices (Ohmeda 2300 Finapres, Ohmeda 2350 Finapres, Task Force Monitor 3040), whose original studies would have established their performance.

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

Not applicable. No new performance study described in this document.

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

Not applicable. No new performance study described in this document.

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 noninvasive hemodynamic monitor, not an AI-assisted diagnostic tool for human readers.

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

The device calculates hemodynamic parameters independently without human intervention during the measurement process, but the interpretation and clinical significance are the physician's responsibility. It's an algorithm-only measurement device, but no standalone performance study specific to this 510(k) is mentioned.

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

For the predicate devices, continuous blood pressure (and derived values) would likely have been validated against invasive arterial lines (for blood pressure) and potentially thermal dilution or other established methods for cardiac output. However, this 510(k) does not detail how the ground truth was established for the predicate devices or for any new validation of the Finometer. It only states that "Cardiac output measured with this device under the Modelflow model requires a calibration with thermal dilution."

8. The sample size for the training set:

Not applicable. The document does not describe a new training set or a machine learning model specific to this 510(k) for which a training set would be required. The device utilizes "Finapres methodology" and "Modelflow method," which are established physiological models, not machine learning algorithms in the modern sense.

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

Not applicable. No training set is described in this document.

In summary, this 510(k) relies on the substantial equivalence of the Finometer to its predicate devices rather than presenting a new, comprehensive study detailing its performance against specific acceptance criteria. The document states that "No new technology, materials, or change in efficacy have been introduced," suggesting that the performance characteristics of the predicate devices are considered valid for the Finometer.

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The Portapres Ambulatory Continuous Non-Invasive Blood Pressure Monitor is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The Portapres enables 24-hour continuous ambulatory measurements.

The PC-based BeatScope software used with the data from the device provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform, including, cardiac output and total peripheral resistance.

Portapres is a portable, battery-powered device to record continuous non-invasive arterial blood pressure. Portapres is intended for 24-hour continuous recordings in ambulatory subjects. The device includes a Neoprene belt to be worn around the waist, with compartments for the Main Unit with electronics and memory card, a Pump Unit with an air pump, and a NiCd or Li battery pack. Connected to the waist belt Main Unit and Pump Unit is a Wrist Unit, used to interface with the signals from the electronics and air supply in the waist belt to the finger cuffs. The Wrist Unit then connects to a finger cuff, which consists of an inflatable air bladder and an infrared photoplethysmograph. The plethysmograph measures the finger arterial volume which varies with the patient's blood pressure. The Wrist Unit controls the pressure in the cuff bladder so as to keep the arterial volume constant at a level (the setpoint) determined during startup. The Wrist Unit contains a pressure transducer that measures the cuff pressure as an indirect measure of the patient's blood pressure. Also connected to the Wrist Unit is a hydrostatic height correction unit that compensates for the hydrostatic component of the blood pressure in the finger when this is not at heart level. This allows the patient free hand movement in ambulatory applications.

Pressure and volume signals from the finger cuffs are routed from the Wrist Unit to the Main Unit microprocessor for pump control and data acquisition purposes. The microprocessor has an internal flash memory card for storage of blood pressure wave form data.

The Main Unit is equipped with an RS232 serial interface to transfer the data stored in the flash memory card via a Control Unit to a PC and to allow remote control of the Portapres.

Here's a breakdown of the acceptance criteria and study information for the FMS Portapres Ambulatory Noninvasive Blood Pressure Monitor, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific numerical acceptance criteria for blood pressure accuracy (e.g., standard deviation, mean difference) as might be found in a more detailed validation report or a standard like ANSI/AAMI SP10.

However, the document states that the Portapres is "substantially equivalent in design (methodology) and indications for use" to predicate devices. This implies that its performance is expected to be comparable to these legally marketed devices, which would have themselves met relevant performance standards for blood pressure accuracy.

The 510(k) summary does not include a table of reported device performance metrics such as mean difference and standard deviation against a reference standard. Therefore, I cannot populate a table with specific numerical performance data directly from this document.

Missing Information: Specific numerical acceptance criteria for blood pressure measurement accuracy (e.g., AAMI/ANSI SP10 standards) and the Portapres's direct performance against those criteria are not provided in this summary. The summary focuses on substantial equivalence to predicate devices, assuming those devices met the necessary performance standards.

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

The 510(k) summary does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) that directly demonstrates the device's accuracy against a gold standard.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. It states: "Portapres and Finapres are substantially equivalent in design, methodology, software, manufacture, materials, intended use and principle of operation." This implies that prior testing and validation of the predicate devices (Ohmeda 2300 Finapres, Ohmeda 2350 Finapres, Task Force Monitor 3040, RODA Monitoring System) are being leveraged.

Missing Information: Direct test set sample size, country of origin, or retrospective/prospective nature of data for the Portapres itself.

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

Since no direct test set demonstrating the device's accuracy is described, there is no information provided regarding experts used to establish ground truth. For blood pressure monitors, ground truth is typically established by trained medical professionals using a reference standard (e.g., auscultatory method with a mercury sphygmomanometer) during a clinical validation study.

Missing Information: Number and qualifications of experts are not mentioned as no direct study for the Portapres's accuracy is detailed.

4. Adjudication Method for the Test Set

As no specific test set or study validating the Portapres's accuracy is described, no adjudication method is mentioned.

Missing Information: Adjudication method is not provided.

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

The summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. Blood pressure monitors are primarily direct measurement devices, and their validation focuses on agreement with reference standards, not on improvement in human reader performance.

Missing Information: No MRMC study was conducted or reported.

6. Standalone Performance Study

The 510(k) summary does not explicitly describe a standalone performance study (i.e., algorithm only without human-in-the-loop performance) for the Portapres.

The claim of substantial equivalence implies that the device's performance, by virtue of its "design, methodology, software," is comparable to its predicates, which would have undergone their own standalone validation. The Portapres itself is a device that generates data (blood pressure waveform and derived parameters), and its standalone performance would be its accuracy in doing so compared to a reference standard. The summary does not provide direct evidence of this for the Portapres specifically.

Missing Information: A specific standalone performance study report for the Portapres is not detailed in this summary.

7. Type of Ground Truth Used

Given that no direct study for the Portapres's accuracy is detailed, the specific type of ground truth used to validate the Portapres cannot be explicitly stated from this document.

However, for non-invasive blood pressure monitors, the gold standard (ground truth) for validation typically involves:

• Auscultatory method: Manual blood pressure measurement performed by trained observers using a stethoscope and sphygmomanometer, often with double or triple auscultation and averaging.
• Intra-arterial catheterization: Invasive measurement, used less commonly for routine non-invasive device validation but considered highly accurate.

The summary's reliance on substantial equivalence suggests that the predicate devices were validated against such ground truths.

Missing Information: The specific type of ground truth used for the Portapres's validation is not detailed.

8. Sample Size for the Training Set

The 510(k) summary does not provide information about a training set or its sample size. The device described, the Portapres, is a measurement device that employs algorithms for continuous blood pressure estimation and hemodynamic parameter calculation (like Modelflow for cardiac output). While such algorithms might be "trained" or developed using data, this summary does not provide details of that process or associated sample sizes.

Missing Information: Training set sample size is not provided.

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

As no training set is described, information on how its ground truth was established is not provided. The algorithms (e.g., Modelflow) would have been developed and validated using physiological data over many years, but these details are not part of this 510(k) submission for the device itself.

Missing Information: Ground truth establishment for a training set is not provided.

Summary of Limitations of the Provided Document:

This 510(k) summary primarily focuses on establishing "substantial equivalence" to existing predicate devices. It does not contain a detailed report of a new clinical validation study for the Portapres itself, which would typically include explicit acceptance criteria, sample sizes, methodology for ground truth establishment, and reported performance metrics. The FDA's acceptance in this case is based on the argument that the new device's design, methodology, and intended use are similar enough to previously cleared devices that it can be presumed to be safe and effective without requiring a full, new, independent clinical validation study report within the summary document.

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