Search Results
Found 1 results
510(k) Data Aggregation
(84 days)
- 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.
| Performance Metric Category | Specific Metrics Examined | Acceptance Criteria (Implicit) | Reported Device Performance (Zymed Holter 2000) |
|---|---|---|---|
| Arrhythmia Analysis | Sensitivities (SE) | Equivalent to predicate device/typical for Holter | Typical for Holter; nearly identical to predicate |
| Positive Predictivity (+P) | Equivalent to predicate device/typical for Holter | Typical for Holter; nearly identical to predicate | |
| False Positive Rate (FPR) | Equivalent to predicate device/typical for Holter | Typical for Holter; nearly identical to predicate | |
| (for QRS, Ventricular, Couplets, Short runs, Long runs) | |||
| ST Analysis | Episode Sensitivities (ESE) | Equivalent to predicate device/typical for Holter | Typical for Holter; nearly identical to predicate |
| Episode Positive Predictivity (E+P) | Equivalent to predicate device/typical for Holter | Typical for Holter; nearly identical to predicate | |
| Duration Sensitivity (DSE) | Equivalent to predicate device/typical for Holter | Typical for Holter; nearly identical to predicate | |
| Duration Positive Predictivity (D+P) | Equivalent to predicate device/typical for Holter | Typical for Holter; nearly identical to predicate | |
| High Heart Rates | Performance for rates in excess of 300 bpm (e.g., pediatric patients) | Within recommended guidelines | Demonstrated to be within recommended guidelines |
| Noise Performance | Performance in presence of baseline, electrode, or muscle noise | Equivalent to predicate device | New system is equivalent to the old system |
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.
Ask a specific question about this device
Page 1 of 1