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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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