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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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