(11 days)
The EK-Pro Arrhythmia Detection Algorithm is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the EK-Pro Algorithm is to monitor ECG parameter data on adult, pediatric and neonatal patients. The EK-Pro Algorithm is designed to monitor ECG parameter data in bedside, portable, and transport monitors that can operate in all professional medical facilities and medical transport modes.
The EK-Pro Arrhythmia Detection Algorithm is a software algorithm that runs in GE Medical Systems Information Technologies patient monitors. When used in a patient monitor, the EK-Pro Algorithm processes the ECG data acquired by the patient monitor to detect various ECG arrhythmia events, and to compute and trend measurements that include heart rate, ventricular ectopic beats per minute, and ST segment deviations.
Here's an analysis of the provided text regarding the EK-Pro Arrhythmia Detection Algorithm, focusing on the requested information:
Unfortunately, the provided text does not contain details about specific acceptance criteria or the numerical results of a study demonstrating the device meets those criteria. The document is a 510(k) summary and approval letter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed validation study results with performance metrics.
However, based on the available information, I can address some of your points:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The document states:
- "The results of these measurements demonstrated that the EK-Pro Conclusion: Arrhythmia Detection Algorithm is as safe, as effective, and performs as well as the predicate device in monitoring ECG parameter data."
This is a qualitative statement about the device's performance relative to its predicate, but it does not provide specific acceptance criteria (e.g., sensitivity, specificity thresholds) or numerical performance results (e.g., 95% sensitivity, 98% specificity).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text. The document mentions "Clinical Acceptance Testing (Validation)" but does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present in the provided text. There is no mention of experts or how ground truth was established for any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text.
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
This information is not present in the provided text. The device is referred to as an "Arrhythmia Detection Algorithm," implying it operates either standalone or as an aid, but there's no mention of an MRMC study or its effect size. The context is that the algorithm processes ECG data, suggesting it's either an automated detection system or provides outputs that human readers would then interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The text describes the device as a "software algorithm that runs in GE Medical Systems Information Technologies patient monitors" and "processes the ECG data acquired by the patient monitor to detect various ECG arrhythmia events, and to compute and trend measurements." This strongly suggests a standalone algorithm without a human-in-the-loop performance study for its primary claims of arrhythmia detection and measurement. While intended for "use under the direct supervision of a licensed healthcare practitioner," this supervision refers to the overall use of the monitor and the information it presents, not necessarily that the algorithm's performance was evaluated in an AI-assisted mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided text.
8. The sample size for the training set
This information is not present in the provided text.
9. How the ground truth for the training set was established
This information is not present in the provided text.
Summary of what is present and relevant:
- Device Type: Software algorithm for arrhythmia detection and ECG parameter measurement.
- Intended Use: Monitoring ECG parameter data on adult, pediatric, and neonatal patients in various medical settings.
- Compliance: Complies with voluntary standards (as detailed in Section 9, which is not provided).
- Validation: "Clinical Acceptance Testing (Validation)" was performed, leading to the conclusion that the device is "as safe, as effective, and performs as well as the predicate device."
- Comparison: Substantial equivalence to predicate device K020290 Dash 3000/4000 Patient Monitor.
- Development Measures: Risk Analysis, Requirements Specification Review, Code Inspections, Software Verification Testing.
In conclusion, for a comprehensive understanding of acceptance criteria and detailed study results, more specific documentation beyond this 510(k) summary would be required. The provided text focuses on the regulatory submission process and the determination of substantial equivalence, rather than a detailed technical report of the device's validation.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.