(49 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 Antiarrhythmia 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 2010 Plus Holter for Windows 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 2010 Plus Holter for Windows. The 2010 Plus Holter for Windows 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 2010 Plus Holter for Windows 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, frequency domain Heart Rate Variability, 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 a breakdown of the acceptance criteria and study information for the Zymed 2010 Plus Holter for Windows, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or target performance format. Instead, it frames the performance by comparing it to industry standards and the predicate device, aiming for "nearly identical" results. The table below summarizes the reported findings in relation to these implicit criteria.
| Feature/Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Holter Performance | Typical for Holter systems (compared to AHA and MIT databases) | "Results were typical for the Holter as targeted." |
| Ventricular Ectopic Beat Detection | Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) meeting standards (specific values not provided in document). | "Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each type of beat...and measured for QRS, Ventricular, Couples, Short runs and Long runs." (Implies results were acceptable, as substantial equivalence was claimed). |
| ST Analysis Performance | Separate sensitivities (DSE) and positive predictivity (D+P) for ST events meeting standards. | "Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. Separate Database and measured for QRS, Ventricular, Couples, Short runs and Long runs. 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| High Heart Rate Performance | Within recommended guidelines in excess of 300 bpm (to include pediatric patients). | "High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm." |
| Performance in Presence of Noise | Equivalent to the predicate system (Holter 2000) for baseline, electrode, or muscle noise. | "Performance in the presence of noise was identical to the old system when looking at baseline, electrode or muscle as the cause of noise." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of patients or recordings) used for the test set. It refers to "industry accepted AHA (AHA), MIT (MIT)" databases for overall Holter performance and the "European ST-T (EST) database" for ST analysis.
- Data Provenance: The data provenance is implied by the use of "industry accepted AHA (AHA), MIT (MIT)" and "European ST-T (EST) database." These are well-known, publicly available databases, suggesting the data is likely retrospective and compiled from various sources. The country of origin for the AHA and MIT databases would primarily be the US, while EST would be Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their qualifications used to establish the ground truth within the AHA, MIT, or EST databases. These databases typically have established ground truths generated by expert cardiologists or technicians following standardized protocols, but the specifics are not in this submission.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing or validating the ground truth in the test sets. It relies on the pre-established ground truths within the referenced industry-accepted databases.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on comparing the new device's algorithmic performance to industry standards and the predicate device, not on how human readers' performance is altered by using the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The document states, "Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) databases" and "Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each type of beat... and measured for QRS, Ventricular, Couples, Short runs and Long runs." This indicates the algorithm's performance was evaluated directly against the established ground truth in these databases, without human intervention in the analysis process itself.
7. The Type of Ground Truth Used
The ground truth used was based on established, "industry accepted" databases:
- Expert Consensus: The AHA and MIT databases are widely known to have rhythm annotations verified by expert consensus.
- Pathology/Clinical Outcomes: While the document doesn't explicitly link to pathology or outcomes for the ground truth, the "European ST-T (EST) database" is used for ST analysis, which implies ground truth related to ischemic events, likely from clinical annotations.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set. It only discusses the evaluation of the device's performance (i.e., the test set).
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established, as details about a training set are not included in this submission. This document focuses on demonstrating substantial equivalence through performance testing against established benchmarks.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).