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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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