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The CoVa™ Monitoring System is intended for use under the direction of a licensed medical professional by adult patients at home to record, store, and transmit the following physiological data: i) Heart Rate including Heart Rate Variability; ii) Thoracic Impedance; iii) Respiration Rate; and iv) Posture. The CoVaTM Monitoring System only displays these physiological data to licensed medical professionals.

The CoVaTM Monitoring System is indicated for patients: i) with fluid-management problems; ii) taking diuretic medication; iii) living with heart failure; iv) living with end-stage renal disease; v) recovering from a coronary artery disease-related event; and/or vi) suffering from recurrent dehydration.

toSense's CoVaTM Monitoring System features a body-worn Sensor, Gateway, and Web-based System.

The Sensor non-invasively measures heart rate (HR), heart rate variability (HRV), respiration rate (RR), and thoracic index (TI). To determine these parameters, the Sensor measures and processes single-lead electrocardiogram (ECG) and thoracic bioimpedance (TBI) waveforms. Additionally, the Sensor measures skin temperature (TEMP) and posture using, respectively, a temperature sensor and accelerometer.

The Sensor has a form factor similar to a conventional necklace, with all measurement electronics built into its strands and base. A pair of customized disposable Electrodes, each featuring two electrode regions, snaps into a magnetic interface on the backside of the base, and then attaches to the patient's chest to make a measurement. The Sensor is designed for measurement periods less than about 5 minutes.

Using a Bluetooth transceiver, the Sensor wirelessly transmits information it measures from the patient to a Gateway, which can be a tablet computer or mobile phone running the Android operating system. Each of these systems receives information from the Sensor, and then forwards it to a Web-based System through either a local-area network (e.g., network based on 802.11), or a wide-area cellular network (e.g. AT&T). The Web-based System displays information, and can also forward it to a third-party system through a web-services interface.

The provided text describes the acceptance criteria and the studies conducted for the CoVa Monitoring System.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., minimum correlation coefficient, maximum mean absolute error). Instead, it presents the results of regression models (slope and intercept) comparing the CoVa system to reference devices and simulators. The implicit acceptance criterion appears to be "substantially equivalent" to predicate devices, as stated in the conclusion.

Further performance details:

• Thoracic Impedance (Clinical Study 1): Average Pearson's correlation with fluid removed by hemodialysis: r = 0.93 (p < 0.0001). Measurement sensitivity: 1.72 Ohms/Liter. Measurement precision for long-term monitoring: 1-2 Ohms. Measurement precision for short-term monitoring: < 1 Ohm.

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

• Clinical Study 1 (Thoracic Impedance):
  • Sample Size: 33 subjects, 13 test devices, 500 measurements.
  • Provenance: Retrospective/Prospective not explicitly stated, but implies prospective collection as subjects "receiving chronic maintenance hemodialysis." Location (country) not specified, but typically assumed to be the US for FDA submissions unless otherwise noted.
  • Subject Type: Subjects "receiving chronic maintenance hemodialysis and, in some cases, suffering from congestive heart failure."
• Clinical Study 2 (Thoracic Impedance):
  • Sample Size: 23 subjects, 2 test devices, 560 measurements.
  • Provenance: Retrospective/Prospective not explicitly stated, but implies prospective collection as measurements were made "daily in the home environment over an extended period of time." Location not specified.
  • Subject Type: Subjects "all having fluid-management issues, such as congestive heart failure."
• Clinical Study 3 (Respiration Rate):
  • Sample Size: 19 subjects, 2 test devices, 682 measurements.
  • Provenance: Retrospective/Prospective not explicitly stated, but implies prospective ("adult subjects undergoing breathing patterns"). Location not specified.
  • Subject Type: "Healthy volunteers using breathing patterns with variable rates and tidal volumes that simulate those encountered by intended-use populations."
• Clinical Studies 4a-e (Absolute Accuracy):
  • Sample Size:
    • 4a (TI): 8 devices, 88 measurements
    • 4b (RR): 1 device, 15 measurements
    • 4c (HR): 1 device, 67 measurements
    • 4d (HRV): 1 device, 15 measurements
    • 4e (TEMP): 1 device, 40 measurements
  • Provenance: Bench studies using simulators. Location not specified.
  • Subject Type: Simulator.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense (e.g., expert consensus on image interpretation). Instead, the ground truth for these studies was established by FDA-cleared reference devices or calibrated simulators.

• Clinical Studies 1, 2, 3: Ground truth was established by "FDA-cleared reference devices" or an "acceptance-standard device" (for RR in Clinical Study 3). The qualifications of personnel operating these reference devices are mentioned as "Trained personnel."
• Clinical Studies 4a-e: Ground truth was established by "calibrated simulators."

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by reference devices or simulators, not human adjudication.

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

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The studies focus on the performance of the device itself against reference standards.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations of the CoVa Monitoring System's algorithms and sensors. The device directly measures and processes physiological data, comparing its output to reference devices or simulators. There is no mention of a human-in-the-loop component in these performance evaluations. The system "only displays these physiological data to licensed medical professionals," implying that professional interpretation occurs after the device has performed its measurements and calculations.

7. The Type of Ground Truth Used

• Clinical Studies 1, 2, 3 (Clinical Trials): FDA-cleared reference devices measuring the same physiological parameters (thoracic impedance, respiration rate).
• Clinical Studies 4a-e (Bench Studies): Calibrated simulators designed to accurately produce known values for thoracic impedance, respiration rate, heart rate, heart rate variability, and skin temperature.

8. The Sample Size for the Training Set

The document primarily describes validation studies and does not provide information on the sample size used for the training set of any algorithms within the CoVa Monitoring System. It focuses on the evaluation of the device's performance post-development.

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

Since the document does not discuss the training set, it does not describe how ground truth for a training set was established.

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