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The uCor Heart Failure and Arrhythmia Management System is intended to periodically record, store, and transmit Thoracic Fluid Index. The uCor Heart Failure and Arrhythmia Management System is also intended to continuously record and store, and periodically transmit ECG, Heart Rate, Respiration Rate, Activity and Posture. The data provided will aid medical professionals as they diagnose and identify various clinical conditions, events, and/or trends.

The uCor Heart Failure and Arrhythmia Management System is intended for use in clinical and home settings and is indicated for patients who are 21 years of age or older:

• i) Who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial fibrillation, atrial flutter, ventricular ectopy, and bradyarrhythmias; or
• ii) requiring fluid management.

The µCor Heart Failure and Arrhythmia Management System noninvasively monitors patients' clinical parameters (Thoracic Fluid Index, ECG, Heart Rate, Respiration Rate, Activity, and Posture). It acquires radiofrequency, ECG and accelerometer signals via the patient-worn device; these raw date are transmitted wirelessly to a remote Server for processing into the clinical parameters. The uCor Heart Failure and Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings, with a monitoring period for up to 30 days.

The µCor Heart Failure and Arrhythmia Management System consists of the following components:

• . Sensor - a patient worn device for signal acquisition.
• . Patch – a single use, disposable adhesive piece adhered to the patient's body and allow for Sensor attachment.
• . Charger – the Charger recharges the Sensor and the Gateway. The Sensor typically requires recharging after 5 days. The Gateway typically requires recharging every day.
• Gateway – An off-the-shelf item, the Gateway is essentially a cellphone that relays data and passes commands between the Sensor and the Server.
• Server – Server refers to the hardware and the processing software, and resides in a cyber-secure location. The software analyzes the raw data received from the Sensor and processes the data into clinical values for eventual presentation to the physicians via an independent monitoring center (IDTF) that is regulated under 42 CFR 410.33.

Raw data from the Sensor to the Gateway is transmitted via Bluetooth; the Gateway then transmits this data to the Server via TCP/IP over WiFi or cellular network for data processing and analysis.

Here's an analysis of the acceptance criteria and study details for the µCor Heart Failure and Arrhythmia Management System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• MaTcH Clinical Study (Thoracic Fluid Index):
  • Sample Size (Test Set): 20 hemodialysis patients.
  • Data Provenance: Prospective, non-significant risk, randomized 2-arm study. The country of origin is not explicitly stated, but the context implies it was conducted in a clinical setting related to device development, likely in the US where FDA clearance is sought.
• VIVUS Clinical Study (ECG, Heart Rate, Respiration Rate, Posture, Activity):
  • Sample Size (Test Set): 15 healthy human volunteer subjects.
  • Data Provenance: Prospective, non-significant risk, non-randomized premarket study. Country of origin not explicitly stated.
• Arrhythmia Detection Algorithm Test:
  • Sample Size (Test Set): ECG databases required by the AAMI/ANSI EC 57:2012 standard. The specific number of cases in these databases is not provided in the text.
  • Data Provenance: Standardized ECG databases. Retrospective, as these are pre-existing datasets. Country of origin not specified for the databases themselves.

3. Number of Experts and Qualifications for Ground Truth Establishment

• MaTcH Clinical Study (Thoracic Fluid Index): The ground truth for thoracic fluid index was based on ultrafiltration volume (UFV) extracted during dialysis sessions. This is an objective clinical measurement. No explicit mention of human experts defining this ground truth is made, as it's a direct physiological measurement used as a reference.
• VIVUS Clinical Study (ECG, Heart Rate, Respiration Rate, Posture, Activity): The ground truth for Respiration Rate, ECG, and Heart Rate was established using a comparator device, the ZOLL X-Series (FDA cleared device under K142915). For Activity and Posture, it's implied that the ground truth was derived from the performed activities (breathing, walking, resting) and potentially observed positions, but no explicit mention of human experts setting this ground truth is made.
• Arrhythmia Detection Algorithm Test: The ground truth was provided as reference results available as part of the ECG databases (per AAMI/ANSI EC 57:2012). These reference results are typically established by expert cardiologists or technicians, often through meticulous manual annotation and consensus, but the specifics of who and how many experts, along with their qualifications, are not detailed in this document.

4. Adjudication Method for the Test Set

• MaTcH Clinical Study: Not explicitly described. The comparison is between the device's measurement, a predicate device's measurement, and the objective UFV, focusing on correlation. No human adjudication is indicated for interpreting the primary outcome.
• VIVUS Clinical Study: Not explicitly described. The comparison is with a comparator device (ZOLL X-Series) for physiological parameters, and for activity/posture, it's against the performed activities. No human adjudication for interpreting these measurements is indicated.
• Arrhythmia Detection Algorithm Test: The test results were compared to reference results available as part of the database. This implies the ground truth in the reference results was already adjudicated or established with high confidence within those standardized databases. The comparison itself was done using "comparison applications provided by PhysioNet," suggesting an automated comparison against the established ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study is described in this document. The studies primarily focus on the standalone performance of the device or its comparison against predicate/reference devices using objective physiological measurements or standardized databases, not on human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

• Yes, standalone performance was done for several aspects:
  • The Arrhythmia Detection Algorithm was tested in a standalone manner by applying the algorithm to ECG databases and comparing its output to reference results.
  • Respiration Rate Measurement Accuracy (bench testing) directly assessed the algorithm's estimation from accelerometer readings against simulated respiration movement.
  • Impedance Measurement Accuracy (bench testing) assessed the device's ability to detect impedance change against a Virtual Network Analyzer, focusing on the core measurement capability.
  • The VIVUS Clinical Study evaluated the µCor 3.0's capability to monitor ECG, Heart Rate, Respiration Rate, Posture, and Activity, comparing its measurements to a comparator device or observed activities. While it involved human subjects, the assessment was of the device's automated measurement and classification capabilities.

7. Type of Ground Truth Used

• Objective Clinical Measurements:
  • Ultrafiltration Volume (UFV) for Thoracic Fluid Index (MaTcH Clinical Study).
  • Measurements from an FDA-cleared comparator device (ZOLL X-Series) for Respiration Rate, ECG, and Heart Rate (VIVUS Clinical Study).
  • Metronome-guided breathing and spontaneous activities for Respiration Rate, Activity, and Posture (VIVUS Clinical Study).
  • Virtual Network Analyzer (VNA) for Impedance Measurement Accuracy (bench test).
  • Simulated respiration movement for Respiration Rate Measurement Accuracy (bench test).
• Expert-Established Reference Results from Standardized Databases:
  • Reference results from AAMI/ANSI EC 57:2012 compliant ECG databases for Arrhythmia Detection Algorithm and Heart Rate estimation. While not explicitly detailed here, such databases rely on expert annotations.

8. Sample Size for the Training Set

• The document describes validation studies and does not provide specific details on the training set size for the AI algorithms used within the device. This information is typically found in the design and development sections of regulatory submissions, not usually in the summary or performance data presented here.

9. How Ground Truth for Training Set was Established

• Similar to the previous point, the document does not specify how the ground truth for any potential training set was established. The studies listed are primarily for validation of the finalized device/algorithms. If machine learning was used, the training set ground truth would have been established separately, likely through expert annotation of various physiological signals to teach the algorithm patterns for arrhythmia, posture, activity, etc.

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