(30 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 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.
- Assessment of EASI derived 12-lead ST measurements is recommended for patients that meet the following parameters.
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- Ages: 33 to 82 years
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- Heights: 147 to 185 cm (58 to 73 in)
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- Weights: 53 to 118 kg (117 to 261 lb)
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- Height to Weight ratios: 1.41 to 2.99 cm/kg ( 0.25 to 0.54 in/lb.)
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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 Holter 2000. 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, derived 12 lead 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 a breakdown of the acceptance criteria and study information for the Zymed 2010 Plus Holter for Windows, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The 510(k) summary claims substantial equivalence to a predicate device (Zymed Holter Scanner Model Holter 2000 - 510(k) K990170) and focuses on the performance of the Holter system in analyzing cardiac data. The acceptance criteria are implicitly tied to maintaining performance levels "typical for the Holter as targeted" and equivalence to the predicate device.
| Acceptance Criteria Category | Specific Metric (Implicit) | Reported Device Performance and Notes |
|---|---|---|
| QRS Detection and Arrhythmia Analysis | Sensitivity (SE), Positive Predictivity (+P), False Positive Rate (FPR) for: QRS, Ventricular, Couplets, Short runs, Long runs | "Separate sensitivities (SE), positive predictivity (+P), and false positive rate (FPR) were examined for each database (AHA), (MIT), (EST) and results were typical for the Holter as targeted... High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm." No specific numerical values are provided for these metrics, only a qualitative assessment of "typical" performance. |
| ST Analysis | Episode Sensitivity (E+P), Episode Positive Predictivity (E+P), Duration Sensitivity (DSE), Duration Positive Predictivity (D+P) | "Separate Episode and measured for QRS, Ventricular, Couplets, Short runs and Long runs. Separate Episode Sensitivity (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." No specific numerical values are provided, only that these were examined. |
| Performance in Presence of Noise | Equivalence to old system with baseline, electrode, or muscle noise | "Performance in the presence of noise indicates the new system is equivalent to the old system when looking at baseline, electrode or muscle as the cause of noise." |
| High Heart Rate Performance (e.g., pediatric patients) | Within recommended guidelines (>300 bpm) | "High heart rates to include pediatric patients were demonstrated to be within recommended guidelines in excess of 300 bpm." |
| Overall Comparison to Predicate (Holter 2000) | Performance data nearly identical | "In summary, performance data between the two systems were nearly identical, and therefore, supports a claim of Substantial Equivalence." |
Study Details from the 510(k) Summary:
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Sample size used for the test set and the data provenance:
- Test Sets: The study utilized industry-accepted databases: AHA (American Heart Association), MIT (MIT-BIH Arrhythmia Database), and European ST-T (EST) database.
- Sample Size: The exact number of patients or recordings within each database is not specified in the provided text.
- Data Provenance: The databases used (AHA, MIT, EST) are generally international, publicly available, and represent retrospective collections of ECG data. The specific country of origin of the data within these databases is not detailed here, but they are widely recognized benchmarks. The study implicitly used this data retrospectively for evaluation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts involved in establishing the ground truth for the AHA, MIT, and EST databases. These databases typically have ground truth established by expert cardiologists or electrophysiologists, but the details are not part of this 510(k) summary.
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Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the ground truth of the test set. Given the use of established public databases, the annotations within those databases are considered the ground truth.
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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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. The study is focused on the standalone performance of the device's algorithms compared to established benchmarks and its predicate device. This is a very early 510(k) submission (2001), and MRMC studies were not standard practice for such devices at that time.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The summary states, "Performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases..." This indicates the algorithm's performance was assessed independently against the pre-established ground truth of these databases.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the test sets (AHA, MIT, EST databases) would be based on expert consensus (manual annotations by cardiologists/electrophysiologists) of the ECG waveforms.
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The sample size for the training set:
- The document does not provide any information regarding the sample size used for training the algorithms. It is common for 510(k) summaries from this era to focus on performance evaluation rather than detailed training methodologies.
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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.
§ 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).