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• 1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmia The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia occurs.
• 2. Holter Mode: Use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG.
• 3. Multi-Lead (Resting EKG) Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.

The ACS Cardiac Outpatient Real Time ECG (CORE™) monitor is a multipurpose device designed with the ability to perform: a 2-lead (2 or 3-electrode) Mobile Cardiac Outpatient Telemetry complete with Arrhythmia Detection and Alarm for up to 30 days; a 24-hour or longer 3-lead (5electrode) or a resting 12-lead (10-electrode) EKG. The ambulatory device may be used on an outpatient basis with remote clinician data analysis as well as use within the physician office setting by a medical professional. The CORE™ monitor is comprised of 1) a single component ECG monitor with an integrated cellular modem and 2) an interface to four independent cable configurations through a single connector. The CORE™ device automatically changes functionality when a specific cable with the same form factor is inserted with the following configurations: 3-wire, ambulatory, snap electrode cable invokes a 1, or 2-lead MCT mode (Lead I, II - no anterior views). 5-wire, ambulatory, snap electrode cable invokes the Holter 3-lead mode by default (up to 5-leads are available with anterior views). 10-wire, resting (lengthened for full body), alligator clip electrode cable invokes the Resting 12-lead EKG mode (8-channels; derived Leads III, aVF, aVR, aVL). A USB cable invokes the PC communication service mode. Cable is interchangeable with ECG lead sets requiring disconnection from the body before connection to an external device can be made. The built-in cellular modem technology pushes and pulls information to and from the device in a HIPAA compliant fashion using the cryptographic protocol; Transport Layer Security (TLS). Additional data integrity is performed by Error Correction Coding (ECC) and MD5 hash sums. The CORE™ device houses a microprocessor for running the algorithm and an Application Specific Integrated Circuit (ASIC) for controlling the CORE™ device, a rechargeable battery, real time ECG Arrhythmia Detection using built-in hardware DSP engine in any mode, ECG capture circuitry provided by the ASIC and the multiple components, GSM/GPRS/EGPRS/WCDMA/HSPA network transceivers for cellular communication, Cellular SIM card, high-capacity SD flash card (up to 1024 GB), internal EEPROM, GPS module, a Bluetooth transceiver and a Zigbee (IEEE 802.15.4) transceiver for bi-directional communication with external devices, a full-color LCD touch screen display, 5-button keyboard, Power and Event button, 3-axis accelerometer, RGB color LED indication module, speaker/microphone, external battery charger, and a USB device port. The CORE™ device utilizes an embedded algorithm developed by Applied Cardiac Systems, Inc. to analyze ECG signals in real-time. Upon detection of an arrhythmic or patient-activated event, the ECG signal is transmitted wirelessly via the cellular network to a remote Monitoring Center for additional analysis and intervention by a clinician. When cellular service is unavailable, the event will be stored until such time the cellular network becomes available or the patient transmits the data using a land telephone line. When in the resting 12-lead EKG mode, the device can capture and display 12 channels of ECG. The ECG can be streamed in real-time to a PC wirelessly via the 802.15.4 network transceiver to be displayed, printed, and stored. An embedded SQL database is used in the device for ECG storage and reporting in all modes - MCT, Holter, and resting 12-lead.

The Applied Cardiac Systems, Inc. CORE™ (Cardiac Outpatient Realtime ECG) device is a multi-purpose device with MCT (Mobile Cardiac Outpatient Telemetry), Holter, and Multi-Lead (Resting EKG) modes. The acceptance criteria and the study results primarily focus on the MCT mode for arrhythmia detection.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for arrhythmia detection are derived from industry standards for evaluating ventricular arrhythmia detectors and are based on sensitivity (Se) and positive predictivity (+P) for event and duration. The reported device performance is compared against these metrics.

Note on Predicate Comparison: The document primarily compares the CORE™ device's performance to predicate devices (Monebo Automated ECG Analysis and Interpretation Software Library (K062282) and Card Guard Scientific Survival Ltd. King of Hearts Express+AF Monitor (K020825)) rather than explicit acceptance criteria with numerical targets. The reported device performance for CORE™ is generally comparable to or exceeds the reported performance of the predicate devices where data is available. For some arrhythmias, the predicates had "insufficient data" or "NA", suggesting the CORE™ device demonstrated performance where the predicates did not provide comparable figures.

QRS Detection Sensitivity and Positive Predictivity (Table 5.1.3.3):

Overall Arrhythmia Detection Accuracy (Table 5.1.3.4):

• Event Sensitivity: 97.59
• Event Predictivity: 94.85
• Duration Sensitivity: 97.35
• Duration Predictivity: 94.30

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

The primary test sets used for evaluating the QRS detection and arrhythmia detection accuracy were:

• AHA (The American Heart Association Database for Evaluation of Ventricular Arrhythmia Detectors)
• MIT-BIH (The Massachusetts Institute of Technology-Beth Israel Arrhythmia Database)
• NST (The Noise Stress Database)
• CU (Creighton University Sustained Ventricular Arrhythmia Database)

These are well-known, publicly available, benchmark databases commonly used for evaluating ECG algorithms. The provenance is therefore well-established academic/research institutions, and the data is retrospective. The specific sample sizes (number of recordings/patients) from these databases for the test set are not explicitly stated in the provided text, but it is implied that the entire databases were utilized for testing, as is standard practice for these benchmarks.

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

The ground truth for the test sets (AHA, MIT-BIH, NST, CU databases) was established during the creation of these publicly available and widely accepted benchmark databases. These databases typically have annotations provided by medical experts, often cardiologists or electrophysiologists, or derived from expert consensus. The specific number and qualifications of experts involved in the original annotation of these databases are not detailed in this submission but are generally considered robust and peer-reviewed given their widespread use in the field.

4. Adjudication Method for the Test Set

The adjudication method for the ground truth of these standard databases (AHA, MIT-BIH, NST) would have been established by the creators of each respective database. While not explicitly stated in the provided document, these databases generally rely on expert review and consensus, potentially involving multiple independent reviewers to establish the "truth" annotations for arrhythmias and QRS complexes.

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

The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the algorithm.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, a standalone study was performed. The tables showing "Accuracy of Arrhythmia Statements & Predicate Comparisons" and "Summary results of AHA, MIT, and NST testing" (Tables 5.1.3.1, 5.1.3.3, and 5.1.3.4) detail the performance of the Applied Cardiac Systems CORE™ algorithm itself, without human intervention. This evaluates the algorithm's ability to detect different arrhythmias and QRS complexes automatically against established ground truths.

7. Type of Ground Truth Used

The type of ground truth used for the QRS and arrhythmia detection evaluations was expert consensus / annotated databases. Specifically, electrocardiogram (ECG) waveform databases (AHA, MIT-BIH, NST, CU) which contain expert-annotated cardiac events and rhythms.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set of the CORE™ device's embedded algorithm. It only mentions the databases used for testing.

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

The document does not explicitly state how the ground truth for the training set was established. Given that the test sets are standard benchmark databases with expert-annotated ground truth, it is highly probable that similar expert-annotated data (either from these databases or other similar datasets) was used for training. However, the specific methodology for training data ground truth establishment is not detailed in the provided text.

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