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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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• Assessment of symptoms that may be related to rhythm disturbances of the heart: Patients with . palpitations; The evaluation of arrhythmia's in patients from pediatric to adult age.
• Assessment of risk in patients with or without symptoms of arrhythmia.
• Assessment of efficacy of Antiarrhythmic therapy. .
• . Assessment of Pacemaker Function.
• Assessment of real time ST segment analysis .
• . Assessment of symptomatic or asymptomatic patients, to evaluate for, ischemic heart disease and arrhythmia analysis during exercise testing.
• Assessment is for single-hospital environment.
• Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the . following parameters.
  • 1. Ages: 33 to 82 years
  • 2. Heights: 147 to 185 cm (58 to 73 in)
  • 3. Weights: 53 to 118 kg (117 to 2611b)
  • 4. Height to Weight Ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/b.)

A Zymed Telemetry monitoring system consists of a series of interface devices to include ECG transmitters, a central Telemetry monitoring computerized unit with a strip chart recorder, Easi 5 (12 lead derived), and laser printer. The Zymed central monitor supports up to eight patients for real time cardiac monitoring. The system displays each patient's ECG continuously on the screen while performing real time ECG waveform analysis for all eight patients. This analysis permits immediate detection and classification of abnormal beats, cardiac rhythm disturbances and variations.

Each ECG transmitter's frequency can be programmed to operate at any frequency within the entire VHF band. For US domestic sites, the transmitters will comply with FCC band allocations (174-216 Mbz). In addition to ECG data, the transmitters also detect and transmit cardiac pacemaker information. Other information including transmitter status and individual lead impedance is also transmitted to the Zymed system for overall system safety and efficacy.

The Zymed system presents the user with a number of clinical tools such as visual and audible alarms and derived 12 lead display for the diagnosis of patients with various heart conditions. The system also provides tools to review a patient's cardiac performance. On-line review mechanisms as well as detailed analysis screens have been designed into the system to facilitate and to enhance the patient's diagnosis and treatment. Features such as individual ECG printouts, multi-channel automatic ST analysis, trend data analysis, and Full Disclosure data further enhance the system's qualities as a valuable and practical clinical tool.

The system has the following options available:
Choice of 4, 6, or 8 bed central monitor
Full disclosure screen and printout (full resolution programmable from 0 to 168 hours)
Choice of 6 lead sets, based on transmitter capability
Full arrhythmia analysis to include multi-channel automatic ST Analysis
12 lead ECGD
Laser Printer, print server options
Strip Chart
Networking

Here's an analysis of the provided text regarding the Zymed Telemetry System, Model EasiView:

Device: Zymed Telemetry System: Model EasiView Telemetry Central Station Monitor

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail manner. 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 real time monitoring environment for the EasiView as targeted." It then lists the types of metrics examined.

Given this, the table below will present the types of performance metrics used and a general summary of the findings as described in the submission.

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

• Sample Size for Test Set: The document refers to "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." However, it does not explicitly state the specific number of cases or recordings from these databases used for testing this particular device.
• Data Provenance: The document implies the use of pre-existing, standardized databases (AHA, MIT, EST). It does not specify the country of origin of the data within these databases or whether the data was retrospective or prospective. Given they are "industry accepted databases," it's highly likely they contain a mix of retrospective data collected over time from various sources.

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

The document does not provide any information about the number or qualifications of experts used to establish the ground truth for the test sets (AHA, MIT, EST databases). For standardized databases like these, the ground truth is typically established by multiple expert cardiologists or arrhythmia technicians through a consensus process, but this submission does not detail that process for these specific databases.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the ground truth of the test set. For pre-existing, standardized databases, the adjudication would have been part of the database creation process, but it's not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses solely on the device's algorithmic performance against established databases and a comparison of its features and performance to a predicate device, not on human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The entire section describing "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases" focuses on the algorithm's performance in detecting QRS, Ventricular events, Couplets, Short/Long runs, and ST analysis, without human intervention in the interpretation process.

7. The Type of Ground Truth Used:

The type of ground truth used was based on the annotations provided within the industry-accepted AHA, MIT, and European ST-T databases. These databases typically contain expert-adjudicated annotations for cardiac events (e.g., QRS complexes, arrhythmias) and ST segment changes, effectively representing expert consensus.

8. The Sample Size for the Training Set:

The document does not specify the sample size for the training set. It only discusses the performance evaluation against established test databases.

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

The document does not provide information on how the ground truth for the training set (if any distinct training was performed using Zymed's own data) was established. It only refers to using "industry accepted databases" for performance testing. If the device was trained using these same databases, the ground truth would be from those databases, which is typically expert consensus.

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The Model 2010 Plus was designed for the busy Holter environment that places a premium on throughput analysis. This powerful computer provides the "muscle" to analyze even the most difficult recordings quickly and accurately.

Three channels of recorded patient ECG are utilized by the sophisticated arrhythmia analysis program to detect abnormalities. The system provides a number of clinical tools such as individual ECG printouts. trend data analysis, HRV time domain, and full disclosure to enable the clinician to review a patients cardiac performance.

The 2010-Plus gives the flexibility to process Holter recordings prospectively or retrospectively. Prospective interaction lets the technician supervise the analysis by viewing the ECG chronologically and fine-tuning the arrhythmia processor on-line for error-free results. Superimposition, paging, or a combination of both techniques can be used for prospective scanning. Or, the system can automatically analyze the data in approximately 12 minutes. Once the preliminary analysis is complete, the technician can use powerful retrospective tools to validate and edit the report.

A Zymed Holter Scanner system consists of a series of interface devices to include a central monitoring computerized unit, a high Resolution Super VGA raster graphics display monitor, a minimum 500 megabites hard disk drive for two 36-hour digital tape readings, Intel Pentium System Board CPU, 8 megabites of RAM, built in math co-processor, cassette tape drive, mouse and keyboard , 3.5 " floppy disk drive, and a laser printer.

Over 1000 final reports can be stored on line, the operating system is DOS compatible, and Holter reports can be transmitted via facsimile systems.

The analysis software package includes standard, pediatric, and AFib to name a few, and the user can program individual custom styles. Other programmable software features include ECG display; scanning speed up to 240 X real time; scanning styles to include retrospective, prospective, superimposition, and paging; auto stops; highlighting; noise algorithm; color schemes, and report formats. The system 3-channel QRS detection/arrhythmia analysis, 3-channel ST segment analysis, full provides disclosure, automatic 2 of 3 channel morphology analysis, customized report software, HRV-Time Domain, and Pacemaker evaluation display.

The provided text is a 510(k) summary for a medical device (Zymed Holter Scanner; Model 2010 Plus) from 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device (Zymed Holter Scanner Model 2010) based on technological characteristics.

Therefore, much of the requested information regarding acceptance criteria and detailed study designs for device performance against specific acceptance criteria is not explicitly present in this 510(k) summary. These summaries, especially from that era, often focused on direct comparison to predicate devices rather than presenting standalone performance studies with pre-defined acceptance criteria in the way a modern regulatory submission might.

However, I can extract and infer some information based on the provided text, while also clearly stating what is not available.

Acceptance Criteria and Study for Zymed Holter Scanner; Model 2010 Plus

The 510(k) summary does not outline specific, quantified acceptance criteria for the new Zymed Holter Scanner Model 2010 Plus in terms of diagnostic performance metrics (e.g., sensitivity, specificity for arrhythmia detection) or a formal clinical study to prove these criteria. Instead, the "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to the predicate device (Zymed Holter Scanner Model 2010) through a comparison of technological characteristics and a general statement about performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" are inferred based on the intention to demonstrate substantial equivalence, as explicit performance thresholds are not provided in the summary.

Study Used to Prove Device Meets Acceptance Criteria:

The key "study" described is a comparison of technological characteristics between the predicate device (Zymed Holter Scanner Model 2010) and the new device (Zymed Holter Scanner Model 2010 Plus). The conclusion drawn from this comparison is that "Performance between the two systems is almost identical and clearly supports a claim of substantial equivalence."

Specific Information based on the text:

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

• Sample Size: Not specified. The summary does not describe a clinical test set or patient data used for a performance validation study. The comparison is based on hardware and software features.
• Data Provenance: Not applicable, as no external data set is described for testing.

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

• Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication is described.

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 study was not described. The device is a Holter scanner, which assists clinicians in analyzing ECG data, but the submission focuses on its equivalence to an existing scanner, not a comparative effectiveness study involving human readers with/without the new scanner. The term "AI" as understood today is also not applicable to this 1998 submission.

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

• A standalone algorithm performance study with quantitative metrics (like sensitivity/specificity for arrhythmia detection) is not explicitly described in the summary. The statement "Performance between the two systems is almost identical" suggests an internal assessment or reliance on the predicate's established performance, but no details are given.

7. The type of ground truth used:

• Not applicable, as no specific ground truth for an independent performance study is described. For a Holter scanner, ground truth for arrhythmias would typically be established by expert cardiologist review.

8. The sample size for the training set:

• Not applicable. This document does not describe a machine learning model requiring a training set in the modern sense. It refers to a "sophisticated arrhythmia analysis program," but details about its development or training data are not provided.

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

• Not applicable. (See #8)

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