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The H-Scribe Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to the Mortara H-12 digital recorder or to other compatible tape or digital recorders. The cardiac data and analysis provided by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns.

The H-Scribe Holter system is intended for use in a clinical setting, by qualified medical professionals, for patients requiring ambulatory (Holter) monitoring of 24 - 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. The analysis software package includes, among others, detection and reporting features appropriate to the indications below:

• Evaluation of adult patients with symptoms related to rhythm disturbances or symptoms suggesting . arrhythmia.
• . Evaluation of adult patients for ST segment changes
• . Evaluation of adult patients with pacemakers
• . Reporting of time domain heart rate variability
• Infant patient evaluation is limited to QRS .

The H-Scribe Holter Analysis system is a PC based diagnostic tool consisting of a Holter analysis software application running on a commercial PC using Windows 98 operating system. Designed in conjunction with the Mortara H-12 Holter recorder, the H-Scribe analyzes prerecorded patient's ECG data that has been stored by the H-12 recorder, or other compatible tape or digital recorders. The system provides three channels of full disclosure for arrhythmia analysis and 12-lead ST segment analysis. The software automatically detects arrhythmia and ST events, and creates summary tables, trends and a final report regarding a variety of cardiac data indices. The cardiac data provided by H-Scribe is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns.

System features and options include a DVD RAM drive provided for long term archival of full disclosure recordings on DVD disks, an included modem for remote technical support, a network card for remote printing and data transfer, and networking capability allowing interface to Hospital Information Systems, through standard protocols.

This document is a 510(k) summary for the Mortara H-Scribe Holter Analysis System. It describes the device, its intended use, and indications for use. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory submission details and a general description of the device's functionality, not on its clinical performance evaluation or the studies proving it meets specific acceptance criteria.

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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. Patients with chest pain suggestive of Prinzmetal's angina.

The Holter 2000 is a device that analyzes recorded cardiac ECG and creates reports from the recorded data. The ECG is pre-recorded onto one of several data storage mediums, which is fed into the Holter 2000. 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 Holter 2000 is used by trained medical personnel to diagnosis patients with various cardiac rhythm patterns. The Zymed 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 Choice of Cassette Tape or Digital Input Laser Printer

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the study used to demonstrate it, structured as requested:

Device: Zymed Holter 2000

1. Table of Acceptance Criteria and Reported Device Performance

The documentation does not explicitly state numerical acceptance criteria. Instead, it describes performance targets as "typical for the Holter as targeted" and states that "performance data between the two systems shows nearly identical data." The acceptance for the Zymed Holter 2000 is based on demonstrating Substantial Equivalence to the predicate device, the Zymed Holter Scanner Model 2010 Plus.

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

• Sample Size: Not explicitly stated as a numerical sample size of patients or recordings. Instead, the performance was measured against "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases."
• Data Provenance: The databases used (AHA, MIT, EST) are generally recognized as public, retrospective datasets of ECG recordings. The specific country of origin for each database isn't detailed in this document but these are widely known and generally include data from various geographical locations historically. The nature of these established databases means the data is retrospective.

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

The document does not provide information on the number of experts or their qualifications for establishing the ground truth of the AHA, MIT, and EST databases. These databases are standardized and their ground truth (annotations) would have been established independently, often by multiple expert cardiologists/technicians, prior to their general acceptance for benchmarking.

4. Adjudication Method for the Test Set

The document does not detail the adjudication method for the test sets (the AHA, MIT, and EST databases). The annotations within these databases are pre-established and considered the reference standard for performance evaluation.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or reported in this document. The study focuses on comparing the new device's automated analysis performance against a predicate device and established databases.

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

Yes, a standalone performance evaluation was done. The document states, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." This refers to evaluating the automated analysis software of the Holter 2000 independent of human interaction during the analysis phase (though human review of results is part of clinical workflow).

7. The type of ground truth used

The ground truth used was expert annotated data from industry-accepted databases (AHA, MIT, European ST-T databases). These databases contain ECG recordings with pre-established annotations (e.g., QRS complexes, ventricular events, ST segment changes) considered as the reference standard.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This type of submission (510(k)) for substantial equivalence, especially in 1999, often focused on validating the performance of the final device against benchmarks, rather than detailing the internal development (training) process. Given the nature of the device as an "analyzer" rather than a deep learning model, it's possible that a "training set" in the modern AI sense wasn't applicable, or it certainly wasn't documented in this submission.

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

Since no training set information is provided, how its ground truth was established is also not detailed.

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