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• Assessment of symptoms that may be related to Rhythm Disturbances of the Heart in patients from pediatric to adult age. Patients with palpitations.
• Assessment of risk in Patients With or Without Symptoms of Arrhythmia. Patients with symptomatic or asymptomatic idiopathic hypertrophic cardiomyopathy and postmyocardial infarction patient with left ventricular dysfunction using arrhythmia e.g .: ventricular ectopy, as method of risk assessment.
• Assessment of Efficacy of Antiarrhythmic Therapy. Patients with baseline high frequency, reproducible, sustained, symptomatic premature ventricular complexes supraventricular arrhythmia or ventricular tachycardia.
• Assessment of Pacemaker Function. Evaluation of patients with paroxysmal symptoms, detection of myopotential inhibition, detection of pacemaker mediated tachycardia, evaluation of antitachycardia pacing device function, evaluation of rate-responsive physiological pacing function.
• Detection of Myocardial Ischemia. Paticnts with chest pain suggestive of Prinzmetal's angina.

The Holter 2000-Software is a device that when installed onto a user's Hardware platform, will convert their system into a Holter scanner analyzes recorded cardiac ECG and creates reports from the recorded data. The patient's ECG is pre-recorded onto one of several data storage mediums, which is fed into user's Holter system whereby the Holter 2000 software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data that is analyzed is individual ECG waveforms and patterns of consecutive waveforms. Cardiac data provided by Zymed's Holter 2000-Software is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns. The Zymed software system presents the user with a number of clinical tools such as ECG report generation. The system also provides tools to review a patient's cardiac performance. Features such as individual ECG printouts, multi-channel automatic ST analysis, multi-channel morphology analysis and Custom Reports further enhance the system's qualities as a valuable and practical clinical tool. The system has the options available: Full Arrhythmia analysis to include multi-channel automatic ST Analysis 12 lead ECGD Data Acquisition on 2 or 3 Channels Digital Input

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zymed Holter 2000 - Software:

Please note that this document is a 510(k) summary for substantial equivalence, not a detailed clinical study report. Therefore, some information, particularly regarding specific statistical thresholds for acceptance criteria and the full rigor of a standalone study, might not be explicitly stated or as granular as one would find in a peer-reviewed publication.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in the traditional sense (e.g., "sensitivity must be > 90%"). Instead, it states that "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases. Results were typical for the Holter as targeted. Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database and measured for QRS. Ventricular. Couplets, Short runs and Long runs. Separate Episode Sensitivities (ESE), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE) and Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database and measured for ST analysis."

The key "acceptance criterion" implied is substantial equivalence to the predicate device, demonstrated by "nearly identical data" for performance.

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

• Sample Size: Not explicitly stated. The document refers to "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." These are known public databases of ECG recordings, but the exact number of cases or recordings utilized for this specific submission is not provided.
• Data Provenance: The databases mentioned (AHA, MIT, EST) are public, widely recognized, and generally well-documented academic/clinical databases. These are typically retrospective collections of patient ECG data. The specific country of origin for each database's full content is varied, but they are international standards.

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

This information is not provided in the document. For industry-accepted databases like AHA, MIT, and EST, the ground truth (annotations) is meticulously established, often by multiple experienced cardiologists or electrophysiologists, following established guidelines. However, the specific process for this submission's use of those databases is not detailed.

4. Adjudication Method for the Test Set

This information is not provided. Given that the ground truth comes from established databases, the adjudication method for their original annotation would have been part of the database creation process. For the purpose of this submission, the device's output was simply compared against the already established ground truth in these databases.

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

No, an MRMC comparative effectiveness study was not done as described in this document. The study focuses solely on the performance of the algorithm (the Zymed Holter 2000-Software) against established ECG databases and a comparison to its predicate device. There is no mention of human readers or AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone study was done. The performance evaluation described is entirely focused on the Zymed Holter 2000-Software's ability to analyze ECG data and generate reports automatically. It measures the algorithm's performance (sensitivities, predictivities, FPR) against the ground truth of the databases. The "Software Trade Name: Holter 2000 - Software" indicates it's an algorithm-driven system for analysis.

7. The Type of Ground Truth Used

The ground truth used was expertly-annotated ECG data from established and industry-accepted databases (AHA, MIT, EST). These databases contain recordings where cardiac events (e.g., QRS complexes, ventricular events, ST changes) have been manually identified and labeled by human experts.

8. The Sample Size for the Training Set

The sample size for the training set is not provided. The document describes a comparison against recognized databases for testing. Information about how the algorithm was trained, including the dataset size, is not included in this 510(k) summary.

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

This information is not provided. As with the training set size, the specifics of the algorithm's development and the ground truth used for its training are outside the scope of this 510(k) summary, which focuses on demonstrating substantial equivalence through testing.

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