(183 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.
- 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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- QT measurements can be used by the physician in risk assessment process indicated for . patients with and without symptoms of arrhythmia. OT measurement is intended to be used by competent health professionals in hospital or clinic environment. Composite QT measures the interval only and is not intended to produce any interpretation or diagnosis of those measurements.
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.
Here's an analysis of the Agilent 2010 Plus Holter for Windows, outlining its acceptance criteria and the study that demonstrates its performance, based on the provided text.
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the same way a PMA or a more recent 510(k) would. As such, some of the requested information (like specific numerical acceptance criteria for performance metrics) is inferred from the overall claim of substantial equivalence and the comparison to industry-standard databases, rather than explicitly stated as acceptance criteria in the document.
Description of the Device and its Purpose
The Agilent 2010 Plus Holter for Windows is a device that analyzes recorded cardiac ECG data to generate reports on various cardiac data, including individual ECG waveforms and patterns of consecutive waveforms. This information is used by trained medical personnel for diagnosing patients with various cardiac rhythm patterns. Its primary function is to provide clinical tools such as ECG report generation, review of patient cardiac performance, multi-channel automatic ST analysis, frequency domain Heart Rate Variability, multi-channel morphology analysis, QT analysis, and custom reports. The key addition in this "Plus" version compared to its predicate is QT analysis.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms (e.g., "sensitivity must be > X%"). Instead, the document frames the acceptance criteria as demonstrating "Substantial Equivalence" to predicate devices, particularly the Zymed Holter Scanner Model Holter 2000, and meeting expected performance against industry-accepted databases. The core assertion is that the performance data between the new system and previous systems were "nearly identical," supporting substantial equivalence.
| Performance Metric/Feature | Acceptance Criteria (Inferred from Substantial Equivalence and Study Design) | Reported Device Performance |
|---|---|---|
| Overall Holter Performance (against standard databases) | Performance "typical for the Holter as targeted" when measured against industry-accepted databases. This implies meeting or exceeding general benchmarks for arrhythmia detection, ST analysis, and noise immunity that would be expected for a Holter system seeking market clearance. | - Results were "typical for the Holter as targeted." |
- Sensitivities (SE), Positive Predictivity (+P), and False Positive Rate (FPR) were examined for each arrhythmia product (PVCs, short runs, long runs) against AHA and MIT databases.
- Duration Sensitivity (DSE), Duration Positive Predictivity (D+P) were examined for the European ST-T (EST) database for ST analysis. |
| Arrhythmia Analysis (PVCs, short runs, long runs) | Performance comparable to the predicate device and expected levels for specific arrhythmia detections when tested against standard databases (AHA, MIT). The implicit criterion is that SE, +P, and FPR are within acceptable ranges for clinical use and are not significantly worse than predicate. | Examined for each arrhythmia product (PVCs, short runs, long runs) against AHA and MIT databases. Performance was deemed "nearly identical" to the predicate. |
| ST Analysis | Performance comparable to the predicate device and expected levels for ST analysis when tested against standard databases (European ST-T). The implicit criterion is that DSE and D+P are within acceptable ranges. | Examined against European ST-T (EST) database. Performance was deemed "nearly identical" to the predicate. |
| High Heart Rate Performance | Demonstrated ability to handle high heart rates, including those seen in pediatric patients (> 300 bpm). | Demonstrated mediator of 31 million in excess of 300 bpm (this phrasing is ambiguous, likely means it could process data with heart rates up to 300bpm, or that it was tested on 31 million beats, with some exceeding 300bpm). The performance in this scenario was consistent with the old system (predicate). |
| Noise Immunity | Performance in the presence of noise (baseline, electrode, or muscle artifact) within recommended guidelines should be comparable to the predicate device. | Performance in the presence of noise (baseline, electrode, or muscle as the cause of noise) was consistent with the old system (predicate). |
| QT Analysis (New feature) | While "performance" of the QT analysis as a diagnostic tool isn't discussed (as it's specifically stated "not intended to produce any interpretation or diagnosis"), the system's ability to measure the interval must be robust and produce consistent, objectively verifiable measurements. The implicit criterion is that the QT measurements themselves are accurate and reliable for aggregation and review by a competent health professional, enabling their risk assessment process. Accuracy of the measurements would be assumed to be validated. | The major difference between the new system and the Zymed 2000 is the addition of QT analysis. No specific performance metrics for QT measurement accuracy are provided in this summary, but its inclusion implies that the measurement function itself was deemed acceptable for its stated use (interval measurement only). The document states "Composite QT measures the interval only." |
| Overall Equivalence | Performance data between the two systems (new and predicate) must be 'nearly identical' such that it supports a claim of Substantial Equivalence. | Performance data between the two systems were "nearly identical." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or ECG recordings. However, the study utilized "industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases." These databases contain standardized ECG recordings with known arrhythmias and ST changes.
- Data Provenance: The data came from established, publicly available, and industry-accepted databases (AHA, MIT, European ST-T). These databases typically contain retrospective ECG recordings from a variety of patient populations. The countries of origin for these specific databases are generally North America and Europe.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified in the provided text.
- Qualifications of Experts: The ground truth for the AHA, MIT, and European ST-T databases is established by expert cardiologists and technicians who have meticulously annotated the recordings. While the document doesn't detail their qualifications for this specific submission, the "industry accepted" nature of these databases implies that their ground truth was established by highly qualified and experienced professionals in the field of cardiac electrophysiology.
4. Adjudication Method for the Test Set
The document does not describe the specific adjudication method used for the pre-existing ground truth within the AHA, MIT, and European ST-T databases. However, for such widely recognized and "industry-accepted" databases, it is common that the ground truth has undergone rigorous review, often involving multiple experts and some form of consensus building or majority vote (e.g., 2+1 or 3+1 methods implicitly or explicitly during their creation). The 510(k) summary focuses on the device's performance against this established ground truth, rather than the methods used to create the ground truth itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not describe an MRMC comparative effectiveness study involving human readers. The study focuses purely on the standalone performance of the algorithm and compares it to a predicate device and established databases. There is no mention of comparing human reader performance with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The performance evaluation discussed in the document ("Overall Holter performance was measured against industry accepted AHA (AHA), MIT (MIT) and European ST-T (EST) databases") describes the algorithm's performance in analyzing ECG data independently. The output of the 2010 Plus Holter for Windows is then used by "trained medical personnel to diagnosis patients," indicating the algorithm's standalone analysis provides the foundation for subsequent human interpretation.
7. The Type of Ground Truth Used
The ground truth used was expert consensus / annotated data from industry-standard databases, specifically:
- AHA (American Heart Association) database
- MIT (Massachusetts Institute of Technology) database
- European ST-T database
These databases are meticulously annotated by cardiologists/experts with confirmed cardiac events (arrhythmias, ST changes), serving as the gold standard for testing ECG analysis algorithms.
8. The Sample Size for the Training Set
The document does not explicitly specify the sample size for the training set. It describes the device as inheriting much of its core functionality from existing Zymed systems ("The only difference between the two Zymed systems is the addition of QT Analysis to the 2010 Plus for Windows System"). This suggests that much of the underlying algorithm was likely trained or developed using extensive datasets over time, prior to this specific iteration. The performance testing against the noted databases would likely be part of a validation or test phase, rather than a training phase for this specific 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As the document does not explicitly detail a training set for this specific submission, it also does not describe how its ground truth was established. However, for a device relying on previously developed algorithms (as implied by the substantial equivalence claim to an older model), the ground truth for any initial training of those algorithms would have been established through methods similar to the test set: expert cardiologists annotating large volumes of diverse ECG data.
§ 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).