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• Designed for Adult and Pediatric Patients.
• For Hospital and Clinic use only.
• For Prescription use only.
  Some of the conditions for use are as follows:
• Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia.
• Evaluation of ECG documentation therapeutic intervention in individual or groups of patients.
• Evaluation of patients for ST segment Changes
• Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
• Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.
• Clinical and epidemiological research studies.

Not Found

This document is a 510(k) clearance letter for the Caird Technology Holter 2000, dated December 13, 2001. It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

Unfortunately, the provided document does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

The letter focuses on the regulatory clearance of the device based on substantial equivalence and outlines general regulations. It mentions indications for use and a precaution about computerized ECG analysis not replacing a physician's diagnosis, but it does not delve into the performance study details.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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: Not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

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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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• 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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