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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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The ZOLL ECG Analysis Software is intended for use by qualified medical professionals for the assessment of arrhythmias. The ECG Analysis Software supports reading and analysis of ECG data recorded in compatible formats. The ECG Analysis Software is intended for use with ECG management software through an electronic interface. The ECG Analysis Software provides ECG signal processing and analysis on a beat by beat basis, QRS and Ectopic Beat detection, heart rate measurement, and rhythm analysis. The ECG Analysis Software is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices.

The ZOLL ECG Analysis Software is a SaMD (Software as a Medical Device) which is of Moderate Level of Concern. It is a software library consists of callable functions that are accessible through an Application Programming Interface (API). The ZOLL ECG Analysis Software provides ECG signal processing, QRS detection, classification of normal/VEB/SVEB, heart rate measurement, and the following rhythm interpretation for up to 3 leads (any combination of the standard 12 leads) of captured ECG data: Bradycardia, Tachycardia, Atrial Fibrillation, Pause, Ventricular Runs, Ventricular Bigeminy / Ventricular Trigeminy, Ventricular Tachycardia, Supraventricular Tachycardia, 2nd Degree Atrioventricular (AV) Block, 3rd Degree Atrioventricular (AV) Block. The ZOLL ECG Analysis Software is made up of: An ECG analysis engine that is responsible for ECG analysis and interpretation, An API to access the ECG analysis engine. The functions of the ZOLL ECG Analysis Software are intended to be called by a Windows application program written in C++, C# or MATLAB using the Microsoft .NET architecture. Furthermore, the ZOLL ECG Analysis Software requires the installation of MATLAB Runtime R2015B for execution. The ZOLL ECG Analysis Software has only been tested and validated to be used with MATLAB R2015B.

The provided document describes the ZOLL ECG Analysis Software and its successful 510(k) submission primarily based on substantial equivalence to a predicate device (Monebo Automated ECG Analysis and Interpretation Software Library, K062282). While it mentions "Performance Test" following AAMI/ANSI EC 57:2012, it does not provide specific acceptance criteria values or detailed performance results. The document states that the performance "meets the clinical requirements for arrhythmia detection and heart rate estimation," but does not list those requirements or the exact results.

Therefore, many of the requested details, particularly quantitative acceptance criteria and performance data, cannot be extracted directly from this document.

Here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not provide a quantitative table of acceptance criteria or specific reported performance values. It only states that the performance "meets the clinical requirements" set forth by AAMI/ANSI EC 57:2012.

2. Sample size used for the test set and the data provenance

• Test Set Description: The document states: "Following AAMI/ANSI EC 57:2012 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms, the ZOLL ECG Analysis Software is applied to the ECG databases required by the standard."
• Sample Size: The exact sample size is not explicitly stated, but it refers to "the ECG databases required by the standard" (AAMI/ANSI EC 57:2012). This standard typically specifies the use of well-known, publicly available ECG databases for performance testing (e.g., MIT-BIH Arrhythmia Database, AHA Database, European ST-T Database). The size of these databases varies, but they typically contain thousands of hours of ECG recordings.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given the reference to AAMI/ANSI EC 57:2012, the databases are generally retrospective and come from various sources (e.g., hospitals, research studies) globally, but often with a strong representation from North American data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Ground Truth Establishment: The document states: "The test results from the ZOLL ECG Analysis Software are compared to the reference results (which are available as part of the databases) using the comparison applications."
• Number/Qualifications of Experts: The document does not specify the number or qualifications of experts used by ZOLL to establish ground truth. However, for the reference databases standardized by AAMI/ANSI EC 57:2012, the ground truth annotations (often called "truth files" or "reference annotations") are typically established through a rigorous, multi-expert consensus process by the creators of those databases (e.g., cardiologists, electrophysiologists, and experienced ECG technicians). The expertise would be in cardiology/electrophysiology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not explicitly stated. The ground truth comes "as part of the databases," implying that the adjudication for these standard databases was performed previously by their original creators, often using methods like "2+1" or multi-reader consensus.

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

• MRMC Study: No, the document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI assistance. The study described is a standalone performance test of the software against a reference standard. The software is intended for use by "qualified medical professionals for the assessment of arrhythmias," implying human oversight, but no study on human-in-the-loop performance is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Yes, a standalone performance test was done. The "Performance Test" section explicitly states, "the ZOLL ECG Analysis Software is applied to the ECG databases required by the standard." This is an algorithm-only evaluation against predefined reference annotations.

7. The type of ground truth used

• Type of Ground Truth: The ground truth used was expert consensus / reference annotations provided as part of the standard ECG databases (e.g., MIT-BIH, AHA) specified by AAMI/ANSI EC 57:2012. These databases have pre-established "reference results" for beat classifications and arrhythmias.

8. The sample size for the training set

• Training Set Sample Size: The document does not provide any information about the training set used for the ZOLL ECG Analysis Software. It focuses solely on the verification and validation (V&V) activities.

9. How the ground truth for the training set was established

• Training Set Ground Truth Establishment: No information is provided regarding the training set or how its ground truth was established, as the document only details the V&V activities.

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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

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