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CONNEOT PULSE is a non-invasive blood pressure measurement system that provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively using a technique in which an inflatable cuff is wrapped around the upper arm. Additionally, the CONNEQT PULSE automatically provides brachial systolic and diastolic blood pressures and heart rate. The measurement range of the cuff circumference is 8.6''-12.6''(22cm-32cm) and 12.6''- 16.5''(32cm-42cm).

The CONNEQT PULSE is designed and manufactured according to IEC 80601 -2-30:2019and consists of the following two parts:

• 1. Brachial systolic and diastolic blood pressure measurements:
     The operational principle is based on the oscillometric method and silicon integrated pressure sensor technology for determining the brachial systolic and diastolic blood pressure. These blood pressure measurement results are classified for hypertension according to the American Heart Association (AHA) guidelines. The user is also alerted if an irregular heartbeat is detected.
• 2. Central blood pressure and cardiovascular indices measurement using Pulse Wave Analysis (PWA):
     The central blood pressure measurement and calculation of corresponding central blood pressure parameters are a subset of the central blood pressure parameters provided by the predicate Atcor SphygmoCor XCEL (K122129).
     The CONNEQT PULSE can be used on its own or with the optional CONNEQT App on the user's smartphone or CONNEQT PRO App on the healthcare provider's portal. Both Apps are used to transmit patient data from the device using paired Bluetooth Low Energy communication for the purpose of storing and displaying the daily blood pressure data and historical trends. Patient data can also be transmitted from the user's smartphone to their HCP to enable HCP monitoring of the user's cardiac health.

Here's a breakdown of the acceptance criteria and the study details for the CONNEQT PULSE device, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to established standards for non-invasive sphygmomanometers and clinical agreement with a cleared reference device.

2. Sample Sizes and Data Provenance

• Test Set for Brachial Blood Pressure:
  • Sample Size: 90 adult subjects (54 female, 36 male)
  • Data Provenance: Not explicitly stated, but clinical studies for FDA clearance are typically conducted in a controlled, prospective manner. The text does not specify the country of origin, but "clinical testing" implies a prospective study.
• Test Set for Central Blood Pressure Parameters:
  • Sample Size: 41 subjects (20 female, 21 male)
  • Data Provenance: Not explicitly stated, but described as an "internal protocol" for validation, suggesting a prospective clinical study. The country of origin is not specified.
• Training Set: Not specified in the provided document. The document focuses on the clinical validation of the device, not the development or training of its underlying algorithms.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Brachial Blood Pressure: The ISO 81060-2:2018 standard typically specifies the use of trained observers for reference measurements (e.g., auscultatory) against which automated devices are compared. The exact number and qualifications of these observers are not detailed in this summary but would be specified within the standard's methodology.
• Central Blood Pressure Parameters: The SphygmoCor CvMS (K070795) device served as the comparator/reference standard. This device itself is cleared, and its output is considered the ground truth for this comparison. The summary doesn't mention human experts establishing ground truth for individual cases; rather, it relies on the output of a previously cleared device.

4. Adjudication Method (Test Set)

• Brachial Blood Pressure: The ISO 81060-2:2018 standard guides observer measurements for ground truth. This often involves multiple observers and a specific protocol to ensure accuracy and minimize bias (e.g., alternating observers, blind measurements). The summary does not provide specific details on the adjudication method used within that study, other than stating it conformed to the ISO standard.
• Central Blood Pressure Parameters: Adjudication is not applicable in the traditional sense here, as the comparison was against a device (SphygmoCor CvMS) rather than against expert human readings that might require adjudication.

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

• No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The CONNEQT PULSE is a device that provides blood pressure measurements and central arterial indices. It is not an AI-assisted diagnostic imaging or interpretation tool where human reader performance is typically evaluated.

6. Standalone Performance Study

• Yes, a standalone study was conducted for the CONNEQT PULSE device. The entire clinical testing section (Section 9.0) describes the validation of the device's accuracy for both brachial blood pressure and central blood pressure parameters as an algorithm/device-only system, without human interpretation being part of the primary measured outcome for its clearance.
  • For brachial blood pressure, its measurements were validated against the ISO 81060-2:2018 standard.
  • For central blood pressure parameters, its measurements were validated against the SphygmoCor CvMS device.

7. Type of Ground Truth Used (Test Set)

• Brachial Blood Pressure: Reference standard measurements as defined by ISO 81060-2:2018 (typically auscultatory measurements by trained observers or an intra-arterial reference).
• Central Blood Pressure Parameters: Measurements from a previously 510(k) cleared comparator device (SphygmoCor CvMS), which serves as the established reference for these parameters.

8. Sample Size for the Training Set

• The document does not provide information regarding the sample size for the training set. This summary focuses on the clinical validation of the final device for regulatory submission, not the developmental phase or the data used to train the underlying algorithms.

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

• The document does not provide information on how the ground truth for the training set was established, as the training set details are not included in this 510(k) summary.

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The SphygmoCor® XCEL System provides a derived ascending aortic blood pressure waveform and a r no ophygmood " Toller director in the measurements are provided non-invasively through the use of a Brachial cuff.

It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

Additionally, the SphygmoCor XCEL System automatically measures Systolic blood pressure and Diastolic blood pressure.

The SphygmoCor XCEL Pulse Wave Velocity (PWV) option is intended to obtain PWV measurements. The PWV option is used on adult patients only.

The SphygmoCor XCEL System is indicated to perform non-invasive cardiovascular measurements as an adjunct to manage various cardiovascular conditions. The device can be used in any of 2 modes:

• 3. Pulse Wave Analysis Measurement (PWA or CP) A brachial cuff is used to measure the peripheral blood pressure and arterial pulses to derive the central blood pressure waveform and corresponding parameters. The brachial blood pressure measurement is calculated using the oscillometric technique. This feature is implemented essentially by a 30 party NIBP Module (SunTech Medical Advantage Mini OEM BP module).
• 4. Pulse Wave Velocity Measurement (PWV) Using a non-invasive Tonometer pressure sensor and Cuff, this mode measures the time difference between the Carotid and Femoral arterial pulses measured simultaneously. To determine the carotid to femoral pulse wave velocity, the distance measured between the two arterial sites is divided by measured time difference. This Pulse Wave Velocity (PWV) is an indicator of arterial stiffness. Higher PWV's are associated with increased arterial stiffness.

The main system components include an electronics hardware module, a tonometer pressure transducer and brachial & thigh cuffs. The basic device operation involves patient's physiological signals being gathered by the electronics hardware module via the patient-contacting cuff and/or tonometer pressure sensor. These signals are then transferred via USB communications to a PC running the Microsoft Windows-based SphygmoCor XCEL Software application. This software application provides the functionality to process the physiological signals and derive the central blood pressure waveform and various other central arterial indices (including Pulse Wave Velocity). The software application also provides a GUI-based interface to allow the operator to initiate measurements and to display the measured waveforms and parameters to the operator.

Here's a breakdown of the acceptance criteria and study information for the SphygmoCor XCEL, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a discrete table of acceptance criteria with specific performance thresholds and corresponding device performance values for the SphygmoCor XCEL in a direct comparison. However, it states that "Side-by-Side Equivalence testing was performed for both the PWA and PWV functions of the SphygmoCor XCEL System against the identified predicates. These comparison tests demonstrated equivalence between the measured and calculated parameters between the predicates and satisfactorily passed the acceptance criteria."

This implies the acceptance criteria were based on demonstrating equivalence to the predicate devices. The type of acceptance criteria would likely be related to statistical equivalence in derived parameters (e.g., central blood pressure waveform and associated indices for PWA, and pulse wave velocity for PWV).

General Acceptance: The device was deemed to have "satisfactorily passed the acceptance criteria," meaning it achieved equivalence to the predicate devices.

Study Details

The document describes several tests performed, broadly categorized as:

• Compliance to FDA Consensus Standards: This involved testing against AAMI/IEC 60601-1, AAMI/IEC 80601-2-30, ISO 81060-2, and IEC 60601-1-2. These are general safety, essential performance, and EMC standards, not direct clinical performance metrics.
• System Verification and Validation testing: This demonstrated that the integration of software and hardware met predefined Product System Requirements.
• Software Verification and Validation testing: Ensured compliance with predetermined specifications.
• Side-by-Side Equivalence testing: This is the most relevant for clinical performance and demonstrating substantial equivalence.

Given the nature of the submission (510(k) for substantial equivalence to predicate devices), the "study" primarily consists of the Side-by-Side Equivalence testing.

1. Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) for the SphygmoCor XCEL itself. The acceptance criteria are framed in terms of equivalence.

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

• Sample Size for Test Set: The document does not explicitly state the number of subjects or cases used for the "Side-by-Side Equivalence testing."
• Data Provenance: The submitter is AtCor Medical Pty Ltd, Australia. The document does not specify the country of origin of the data for the equivalence testing. It is a retrospective or concurrent comparison study against predicate devices, as it evaluates the new device side-by-side with existing, cleared devices.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: The document does not mention the use of experts to establish ground truth for this specific equivalence testing.
• Qualifications of Experts: Not applicable, as experts are not mentioned in this context. The study compares the new device's readings to those of predicate devices, which are already accepted as providing valid measurements.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not describe an adjudication method. This is likely because the "ground truth" for the equivalence study is the measurements obtained from the predicate devices, rather than a subjective expert assessment requiring adjudication.

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

• MRMC Study: No, the document does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is a measurement system, not an AI-assisted diagnostic imaging interpretation tool.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

• Standalone Performance Study: The "Side-by-Side Equivalence testing" can be considered a form of standalone performance evaluation in the context of a measurement device. It assesses the device's output (measurements) directly against predicate devices. The system performs automatic measurements, and the comparison is of these automated outputs. The performance data section refers to "System Verification and Validation testing" and "Software verification and validation test results" which also fall under standalone testing.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "Side-by-Side Equivalence testing," the ground truth is effectively the measurements obtained from the predicate devices (SphygmoCor CvMS System for PWA, SphygmoCor CvMS-PWV System for PWV, and Cheetah Reliant for NIBP). The assumption is that these predicate devices provide an accepted and validated measurement.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not specify a sample size for a training set. While the device uses software, the context is not of a machine learning or AI model that requires a distinct training set in the typical sense for a 510(k) submission of this nature. The "General Transfer Function (GTF) methodology" mentioned for deriving the central pressure waveform is a validated algorithm.

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

• Ground Truth for Training Set: Not applicable in the context of this 510(k) submission as no distinct training set for a new machine learning algorithm is described. The GTF methodology for PWA is stated to be "validated," implying its performance has been established previously, likely using invasive catheter measurements as the ground truth in its initial development and validation.

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The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.

The CvMS Pulse Wave Velocity (PWV) option is intended for use in obtaining PWV measurements. The PWV option is used on adult patients only.

The SphygmoCor CvMS device (un-modified device) is a computerized tool for providing a derived ascending aortic blood pressure waveform and a range of central anterial indices. The CvMS is used with a tonometer over the radial artery to capture a pressure waveform which is used to derive central pressure and is calibrated with a standard blood pressure cuff measurement. The CvMS is intended for use on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. In addition, the CvMS incorporates an option to enable users to measure Heart Rate Variability (HRV) in response to controlled exercises.

The SphygmoCor CvMS with the PWV option (modified device) is a software addition to the SphygmoCor CvMS device (K070795). This software feature provides an additional central arterial indice - Pulse Wave Velocity (PWV).

The provided document describes the SphygmoCor Cardiovascular Management System (CvMS), with a specific focus on the Pulse Wave Velocity (PWV) option.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria for the PWV measurement or a detailed performance report against such criteria. Instead, it states that "All tests confirmed the product met the acceptance criteria" and that a clinical comparison study "demonstrated similar performance between the two devices" (the modified SphygmoCor CvMS with PWV and its predicate).

While explicit acceptance criteria are not provided, the implied acceptance criteria are:

• The software verifies and validates correctly.
• The device performs similarly to the predicate device in a clinical comparison.

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

The document states, "a clinical comparison study was conducted." However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given that the predicate device is also a non-invasive blood pressure and cardiac monitor, the "ground truth" for the comparison would likely be the measurements provided by the predicate device itself.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The clinical comparison mentioned is between two devices, not an assessment of human reader performance with and without AI assistance. Therefore, there is no effect size given for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance

The document does not explicitly present a standalone (algorithm only) performance study with metrics like sensitivity, specificity, or accuracy. The focus is on the performance of the device (which includes the software/algorithm) as a whole, compared to a predicate device. The software verification and validation activities are mentioned, implying that the algorithm's functionality was tested, but not in terms of traditional standalone diagnostic performance metrics.

7. Type of Ground Truth Used

The type of ground truth for the clinical comparison study was based on the performance of a legally marketed predicate device. Specifically, the unmodified SphygmoCor CvMS (K070795) and the Vascular Profiling System VP-2000 (K013434) were used as predicates for equivalence. The study aimed to show "similar performance" to these established devices rather than against an independent, gold-standard ground truth like pathology or long-term outcomes data.

8. Sample Size for the Training Set

The document only refers to a clinical comparison study and internal design/verification activities. It does not mention a separate training set or its sample size for the development of the PWV algorithm. It describes the PWV option as a "modular software addition" that calculates PWV using existing tonometry and ECG capabilities from the predicate device. This suggests that the algorithm leverages established physiological principles rather than being a machine learning model requiring a distinct training set in the typical sense.

9. How Ground Truth for the Training Set Was Established

Since a distinct "training set" for a machine learning algorithm is not mentioned, the document does not describe how ground truth for such a set was established. The PWV calculation method is explicitly defined as "measuring the distance between the two arteries and then dividing by At" (where At is the time difference between two pressure waveforms using ECG as a timing reference), indicating a deterministic algorithmic approach rather than a learned model from a labeled dataset.

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The SphygmoCor® Cardiovascular Management System (CvMS) provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The CvMS is used with a tonometer over a radial artery calibrated with a standard cuff blood pressure measurement. It is to be used on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The CvMS Heart Rate Variability (HRV) option is intended for use in obtaining HRV measurements in response to controlled exercises.

The CvMS is a modified version of the SphygmoCor Px (K012487). Like its predecessor, the CvMS is a computerized tool for the assessment of a range of central vascular parameters, including blood pressure, by peripheral pulse wave detection, callbration, and analysis that can be derived from the calibrated peripheral pressure waveform. The CvMS is used with a tonometer over the radial artery, and is calibrated with a standard blood pressure cuff measurement. The CyMS is intended for use on those patients where information related to ascending aortic blood pressure is desired but in the opinion of the physician, the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits. In addition, the CvMS incorporates an option to enable users to measure Heart Rate Variability (HRV) in response to controlled exercises.

The CvMS is made up of three primary components: 1) a proprietary signal processing electronics module; 2) proprietary software; and 3) a Millar Micro-Tip Pulse Transducer tonometer (Millar tonometer).

One notable new feature incorporated into the CvMS is the addition of the capability to noninvasively measure Heart Rate Variability (HRV) data. The CvMS measures the variability in intervals between R waves ("R-R intervals") on a continuous beat-to-beat basis for a period of time to provide HRV data and to use standard analysis procedures to provide stable and evoked measures of HRV in response to certain controlled exercises. The CvMS is also capable of providing Central Blood Pressure (PWA) and Pulse Wave Velocity (PWV) measurements.

The CvMS system is available in three different configuration options based upon these measurement capabilities. These options allow the user to select a measurement system that suits their particular clinical needs. These configuration options include:

1. SphygmoCor Px Pulse Wave Analysis (PWA) System (Px);
2. SphygmoCor Vx Pulse Wave Velocity (PWV) System (Vx); and
3. SphygmoCor Hx Heart Rate Variability (HRV) System (Hx).

All measurements may be stored and viewed on an attached computer which is attached to the CvMS's signal processing electronics module via a standard USB cable. The patient study reports are displayed on an attached computer.

Here's a breakdown of the acceptance criteria and study information for the SphygmoCor Cardiovascular Management System (CvMS), based on the provided text:

Acceptance Criteria and Device Performance

Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards, rather than specific numerical acceptance benchmarks for clinical accuracy.

Study Information

The document describes performance testing and comparison testing rather than a formal clinical study with a specific test set.

• Sample Size Used for the Test Set and Data Provenance:

  • The document states "comparison testing between the CVMS and the SphygmoCor Px demonstrated that the devices performed substantially the same." However, it does not specify the sample size for this comparison or the data provenance (e.g., country of origin, retrospective/prospective).

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

  • Not applicable/Not specified. The testing described is a comparison against a predicate device and compliance with standards, not a ground truth established by experts on a test set in the traditional sense.

• Adjudication Method for the Test Set:

  • Not applicable/Not specified.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

  • No. An MRMC study is not mentioned. The device is standalone, and the assessment is of its performance compared to a predicate device and safety standards, not an AI-assisted human reading task.

• Standalone Performance (Algorithm Only) Study:

  • Yes. The described "hardware and software verification and validation testing" and "comparison testing between the CVMS and the SphygmoCor Px" are essentially standalone performance assessments of the device's algorithms and functionality. The comparison confirms its performance matches the predicate device.

• Type of Ground Truth Used:

  • For the comparison testing of the derived ascending aortic blood pressure waveform and central arterial indices: The "ground truth" was the performance of the legally marketed predicate device, SphygmoCor Px (K012487).
  • For safety and electrical standards: Compliance with recognized industry standards (IEC60601-1, IEC60601-1-2, AAMI EC13:2002) served as the "ground truth" for meeting those requirements.

• Sample Size for the Training Set:

  • Not applicable/Not specified. This device is a modified version of an existing system, and the description focuses on verification and validation of the modified system, not the training of a new AI algorithm.

• How the Ground Truth for the Training Set Was Established:

  • Not applicable/Not specified. (See above)

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The SphygmoCor Px is indicated for use in those patients where information related to the ascending aortic pressure is desired, but in the opinion of the physician, the risks of the intra-arterial radial artery pressure recording procedure may outweigh the benefits of using the SphygmoCor Mx system with an invasive radial pressure input.

The SphygmoCor Px provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. The SphygmoCor is used with a tonometer over the radial artery calibrated with a standard cuff blood pressure measurement. It is to be used in those patients where information related to the ascending aortic pressure is desired but in the opinion of the physician, the risks of the cardiac catheterization procedure or other invasive monitoring may outweigh the benefits.

The SphygmoCor SCOR-Px is a computerized tool for the assessment of blood pressure. The SphygmoCor can calculate the calibrated ascending aortic pressure probater - 110 g the radial artery pressure waveform recorded non-invasively from a radial artery tonometer and a brachial cuff measurement.

An eight-second segment of the radial artery pressure signal is processed in the SphygmoCor electronics module to derive the calibrated ascending aorta pressure waveform and to derive central pressure waveform parameters.

The signal processing electronics module is attached to a PC computer through a serial RS-232C port.

The patient's study report appears on the PC computer and displays the measured (radial) and calculated (central) waveforms, allows input of patient information, and provides the operator with instructions. It uses an IBM-compatible computer (notebook or desktop) to run the SphygmoCor computer software suite.

Here's an analysis of the provided text regarding the SphygmoCor Px device, addressing your specific questions, with the caveat that the supplied document is a 510(k) summary and not a full study report, so some details are not explicitly stated.

The SphygmoCor Px is a computerized tool designed to provide calibrated central aortic pressure waveforms non-invasively. It achieves this by using a non-invasive tonometer over the radial artery, calibrated with a conventional brachial cuff measurement. Its primary function is to derive the central aortic blood pressure waveform and associated arterial indices.

Acceptance Criteria and Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device (SphygmoCor Mx) rather than specific numerical acceptance criteria for performance metrics like accuracy, sensitivity, or specificity. The core acceptance criterion for the SphygmoCor Px is that its non-invasive radial artery waveform acquisition method is substantially equivalent to the invasive method used by the predicate device for generating central aortic pressure waveforms.

Study Details:

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

   • Sample Size: The provided text does not specify the sample size for the Kelly et al. study.
   • Data Provenance: The document implies the study was conducted by Kelly et al., but does not state the country of origin of the data. The study compared invasive and non-invasive radial artery pressure waveforms. Given the nature of medical device development, it's highly likely to be a prospective study designed for this comparison.

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

   • The document does not mention the use of experts to establish ground truth for the test set in the way often seen for AI/image analysis devices. The comparison is between two methods of acquiring radial artery waveforms, with the invasive catheter measurement serving as the de facto "ground truth" for waveform acquisition. Therefore, a separate expert consensus for the test set, beyond the physician's role in performing the invasive procedure, is not described or apparently necessary for this type of comparison.

3. Adjudication Method for the Test Set:

   • Given the nature of the comparison (invasive vs. non-invasive waveform acquisition), adjudication methods like 2+1 or 3+1 are not applicable and are not mentioned. The comparison is objective, based on signal analysis.

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

   • No, an MRMC comparative effectiveness study was not performed or described. The device is a "Blood Pressure Computer" that calculates a waveform, not an diagnostic imaging device where human readers interpret outputs. The comparison is at the level of the input data (radial artery waveforms).

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • The document implies a standalone performance comparison in the context of the Kelly et al. study. The comparison is specifically between the invasively acquired radial waveform and the non-invasively acquired radial waveform. The SphygmoCor Px then processes the non-invasive waveform using the same signal processing software as the predicate device (SphygmoCor Mx). Therefore, the "algorithm only" performance is assessed by confirming the equivalence of the input waveforms to this shared algorithm. Once the input is equivalent, the algorithmic output is assumed to be equivalent.

6. Type of Ground Truth Used:

   • The ground truth for the comparison in the Kelly et al. study implicitly involves invasively measured radial artery pressure waveforms acquired via catheter. This is considered the gold standard for direct arterial pressure measurement.

7. Sample Size for the Training Set:

   • The document does not mention a separate "training set" as one would typically see for machine learning or AI models. The SphygmoCor Px uses existing signal processing software that was presumably developed and validated over time. The Kelly et al. study is a validation study comparing the input data streams, not a training study for the algorithm itself.

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

   • As there's no explicitly mentioned "training set" for the SphygmoCor Px's algorithm, this question is not directly applicable to the information provided. The signal processing algorithms for deriving central aortic pressure waveforms were likely developed and validated against invasive central aortic pressure measurements (e.g., from cardiac catheterization) in previous research, which forms the basis for both the SphygmoCor Mx and Px. However, the details of that initial algorithm development and validation are not supplied in this 510(k) summary.

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