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The CoVa Monitoring System 2 is intended for adult patients under the direction of a licensed medical professional or by clinical personnel trained in its proper use. It is intended to record, store, and transmit the following physiological data: i) heart rate including heart rate variability; ii) respiration rate; iii) thoracic impedance; in) estimated stroke volume; v) estimated cardiac output; and vi) posture. It displays these physiological data, along with ECG and impedance waveforms, to the licensed medical professionals and/or clinical personnel. The information should be integrated into the context of all clinical data to make determinations of patient status.

The CoVa Monitoring System 2 is indicated for patients with fluid-management disorders managed by regular use of diuretics, and/or suffering from a disease or medical condition characterized by an increase in fluid, such as kidney failure, heart failure, and/or edema caused by a chronic disease (e.g. heart failure) normally treated with a diuretic.

The following are contraindications for the CoVa Monitoring System 2:

· The System is not defibrillator-proof. Thus its Sensor should be removed from a patient before using an external defibrillator.

· The System includes magnetically active materials, and thus should not be used by patients undergoing a procedure involving magnetic resonance imaging (MRI).

· The System should not be used by patients diagnosed with severe cardiac arrhythmias.

· The System should not be used by critically ill patients.

toSense's CoVa TM 2 features a body-worn Sensor, Gateway, and Web-based System. The Sensor has the same mechanical form factor and functionally equivalent electronic systems as the CoVa TM 1 Sensor. Both Sensors perform measurements by non-invasively sensing and processing single-lead electocardiogram (ECG) and thoracic bioimpedance (TBI) waveforms. The Sensor in CoVa TM 2, like that in CoVa TM 1, uses these two waveforms to measure heart rate (HR), heart rate variability (HRV), respiration rate (RR), and thoracic impedance (TI). The specifications for these measurements, calculated using the rank-regression method, are included in the 510(k) Summary for K142087. Embedded software within the CoVa TM 2 Sensor has been modified to also estimate stroke volume (SV) and cardiac output (CO) from the ECG and TBI waveforms. Additionally, both Sensors measure skin temperature (TEMP) and posture using, respectively, a temperature sensor and accelerometer. The Sensor has a form factor similar to a conventional necklace, with the electronics built into its strands and base. To make a measurement, 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. The Sensor is typically used for measurement periods less than 5 minutes but can also be used for longer periods (e.g. several hours).

Using a Bluetooth™ transceiver, the Sensor wirelessly transmits measurement information from the patient to a Gateway, such as a tablet computer or mobile phone running the Android operating system. These systems receive information from the Sensor, and then forward it to the 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 forward it to a thirdparty system through a web-services interface.

The provided text describes the CoVa Monitoring System 2 (CoVa™ 2) and its clinical study to demonstrate substantial equivalence, particularly for Stroke Volume (SV) and Cardiac Output (CO) measurements.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for SV and CO measurements were established as demonstrating non-inferiority to a predicate device (CardioDynamics BioZ monitor) when compared against a gold-standard reference device (GE Medical Systems Discovery MR 450 cardiac MRI). Specifically, the agreement between the test device (CoVa™ 2) and the reference device should be as good or better than the agreement between the acceptance-standard device (BioZ monitor) and the reference device.

"Agreement" was determined from the 95% limits of agreement (LOA) and also evaluated using mean squared error (MSE).

Here's a table summarizing the performance compared to the acceptance criteria for the intended-use subgroup:

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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

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