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The Heart Rate Variability (HRV) Acquire device is intended to record and indicate the following parameters during autonomic testing maneuvers:

• Expiratory pressure recording and display
• Respiratory effort
• Breathing cue metronome
• Heart rate via electrocardiography (ECG)
• Non-invasive beat-to-beat blood pressure from optional external device

The HRV Acquire does not make a diagnosis or indicate by itself any disease state exists. The HRV Acquire is not designed for vital signs monitoring or self monitoring of patients.

The HRV Acquire (HRV) Device with TestWorks software can be used as a standalone cardiovagal device to support heart rate variability testing and expiratory pressure evaluation during valsalva breathing testing. The HRV device supports measurement of heart rate variability, respiratory effort from commercially available circumferential chest bellows, display of a valsalva breathing metronome breathing cue and display of non-invasive beat to beat blood pressure from an external device. An example of an external blood pressure device is the commercially available FMS Finometer, cleared to market by 510(k) K880572. Other commercially available, FDA cleared to market external beat to beat blood pressure devices with an analog blood pressure signal output may be applied.

The HRV device user interface is integrated into the existing WR Medical Electronics CO TestWorks software. The Test Works software was cleared to market with the Q-Sweat device, 510(K) K992874. The Test Works software is modified to support an interface to the HRV device.

The HRV device may be mounted to a standard IV Pole.

The HRV device has two modes of operation:

• 1. Valsalva Mode supporting valsalva breathing cue to the subject under test,
• 2. Heart Rate Deep Breathing (HRDB) Mode.

In both modes, the HRV device acquires and the TestWorks software displays heart rate and blood pressure. The HRV device eliminates the need for a separate ECG acquisition device when these types of studies are performed. The HRV device acquires a Lead II ECG signal.

The HRV device and TestWorks software do not supply any alarms. All interpretation of acquired and displayed data is the responsibility of the physician/clinician supervising the test.

Here's an analysis of the acceptance criteria and study information for the WR Medical Electronics CO. Heart Rate Variability Device (HRV Acquire), based on the provided 510(k) Summary K092809.

This document describes a medical device rather than an AI/ML device. Therefore, many of the typical AI/ML study components (like expert ground truth for a test set, MRMC studies, standalone algorithm performance, and training set details) are not applicable or detailed in this submission. The "study" described here focuses on demonstrating the device's functionality, safety, and equivalence to predicate devices, which is standard for traditional medical device clearances.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on the technical specifications and comparison to predicate devices, rather than clinical performance metrics typical of diagnostic algorithms. The "performance" is reported as compliance with these specifications and standards.

Study Details (Focusing on Device Functionality and Safety)

Since this is a traditional medical device (not AI/ML), the "study" is primarily a series of verification and validation tests to ensure the device meets its design specifications and complies with relevant standards.

1. Sample size used for the test set and the data provenance:

   • The document does not specify a "test set" in the context of patient data or clinical cases for performance evaluation in the way an AI/ML device would.
   • The testing described is system-level verification and validation. This typically involves using simulated signals, test equipment, and potentially a limited number of human subjects for usability and basic functionality checks, but the details (sample size, data provenance like country, retrospective/prospective) are not provided as they are not typically required for this type of submission.

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

   • Not applicable in the typical AI/ML sense. Ground truth for hardware/software verification typically involves comparing device outputs to known inputs from test equipment or established engineering standards.
   • Any human evaluation would be conducted by engineers, technicians, or clinicians for functional testing, but they wouldn't be "establishing ground truth" for diagnostic accuracy.

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

   • Not applicable. Adjudication methods are used for resolving disagreements in ground truth labeling for clinical data, which is not the primary focus of this device's validation.

4. 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 measurement tool, not an AI-assisted diagnostic. It provides raw data and measurements for a clinician to interpret. There is no "human reader" using "AI assistance" with this device.

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

   • The term "standalone" here would mean the device accurately acquires and displays the specified parameters. The 510(k) summary indicates that "testing of the Heart Rate Variability device was performed in compliance with the WR Medical Electronics CO. design control process," including "Software verification and validation" and "System verification." This implies its standalone functionality was tested against its specifications. The device does not make a diagnosis; "All interpretation of acquired and displayed data is the responsibility of the physician/clinician supervising the test." Thus, its "standalone performance" refers to its ability to accurately measure and display parameters.

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

   • For hardware and software verification, the "ground truth" is typically defined by:
     • Known input signals: e.g., electrical signals from a signal generator for ECG and R-wave detection accuracy.
     • Calibration standards: for pressure and timing measurements.
     • Engineering specifications: The device is tested to ensure its output matches expected values given specific inputs according to its design.
     • Compliance with recognized standards: Such as AAMI EC13 for cardiac monitors.

7. The sample size for the training set:

   • Not applicable. This is a traditional medical device, not an AI/ML system that requires a "training set" for model development.

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

   • Not applicable, as no training set exists for this type of device.

Summary of the Study:

The "study" described in the 510(k) summary for the HRV Acquire device is a design control verification and validation process. This process aimed to demonstrate that the device meets its predetermined technical specifications and complies with relevant safety and performance standards. Key aspects of this process included:

• Software verification and validation: Ensuring the software operates as intended and meets requirements.
• System verification: Confirming that the integrated hardware and software function correctly together.
• Compliance with AAMI EC13:2002/(R)2007: Adherence to this standard for cardiac monitors, heart rate meters, and alarms. This implicitly sets performance targets for ECG and R-wave detection accuracy.
• Safety standard compliance: Meeting requirements of EN/IEC 60601-1 and EN/IEC 60601-1-2 (electrical safety and electromagnetic compatibility).

The conclusion of the submission states, "The safety and effectiveness of the Heart Rate Variability device was demonstrated by testing in compliance with the Design Control process." This indicates that the device successfully passed these verification and validation activities, and by meeting its specifications and standards, it was deemed substantially equivalent to predicate devices.

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