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The ZOLL Arrhythmia Management System (AMS) is intended to continuously record, store, and 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.

AMS is intended for use in clinic and home settings. AMS is indicated for patients who are 21 years of age or older who require monitoring for the detection of non-lethal cardiac arrhythmias, such as, but not limited to, atrial flutter, ventricular ectopy, and bradyarrhythmias.

The ZOLL Arrhythmia Management System (AMS) noninvasively monitors patients' clinical parameters (ECG, Heart Rate, Respiration Rate, Activity, and Posture). These raw data are transmitted wirelessly to a remote Server for processing into the clinical parameters. The ZOLL Arrhythmia Management System is for prescription use only. It is intended for use in outpatient clinic and home settings.

The ZOLL 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.

The ZOLL Arrhythmia Management System Patch and Sensor will be placed on the upper left chest ("front" location).

The acceptance criteria and study proving the device meets them are described below.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Arrhythmia Detection Algorithm Test Set: Specific sample size is not explicitly stated, but the testing was done to ANSI/AAMI EC57:2012. Data provenance is not specified in terms of country of origin or retrospective/prospective nature for this particular test.
• Equivalency of ECGs Study: 43 volunteers (22 females, 21 males) participated. This was a prospective study. The country of origin is not explicitly stated.
• Vital Signs Validation Study (Leveraged from Predicate Device): 15 healthy volunteers (9 females, 6 males) participated. This was a prospective study. The country of origin is not explicitly stated.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth for the arrhythmia detection algorithm performance tests or the vital signs validation study.
For the "Equivalency of ECGs" study, the comparison was against a "standard lead-II device," implying established ground truth from a conventional medical device, but not necessarily human expert adjudication for each waveform.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for establishing ground truth in any of the studies mentioned. The comparisons appear to be against established standards or conventional medical devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not reported. The studies described focus on the standalone performance of the device or its equivalence to established monitoring methods, not on how human readers improve with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone (algorithm only) performance evaluation was done for the "ZOLL Arrhythmia Management System detection algorithm" against ANSI/AAMI EC57:2012. Additionally, the equivalency and vital signs validation studies assessed the device's ability to capture and measure physiological parameters independently.

7. The Type of Ground Truth Used:

• Arrhythmia Detection Algorithm: The ground truth was established by adherence to the performance requirements outlined in ANSI/AAMI EC57:2012. This is a recognized industry standard for arrhythmia detectors.
• Equivalency of ECGs: The ground truth was established by comparison to a standard lead-II ECG system.
• Vital Signs Validation Study: The ground truth for ECG, Heart Rate, Respiration Rate, Posture, and Activity was likely derived from accepted measurement methods for these parameters, though not explicitly detailed. The study validated the device's capability to monitor these parameters, implying a comparison to known or referent values.

8. The Sample Size for the Training Set:

The sample size for the training set for the arrhythmia detection algorithm is not provided in the document.

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

The document does not describe how the ground truth for the training set was established for the arrhythmia detection algorithm.

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