(173 days)
EK12 V2 analyzes 10 or more seconds of a previously acquired electrocardiogram (ECG) from physiological ECG signal recording devices for rhythm and measurements.
EK12 is used to create reports intended for use by a Qualified Medical Professional, including a trained ECG Technician operating within Independent Diagnosic Testing Facility (IDTF) requirements and performance standards for the review and assessment of an ECG.
EK 12 V2 is indicated for use on adults and pediatric patients older than 2 years. The device is intended for use in an IDTF or a professional medical facility, such as a hospital, clinic, or physician's office.
EK12 V2 algorithm is a software only product that provides computerized measurements from the ECG parameter data acquired by the host device. EK12 V2 analyzes ECG recordings for rhythm and measurements that is deployed as part of a host system used to generate ECG reports
Here's a breakdown of the acceptance criteria and study information for the EK12 V2 Algorithm, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics from a study. Instead, it states that "The EK12 V2 Algorithm complies with the voluntary consensus standard AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms."
This implies that the acceptance criteria are the performance requirements outlined in the AAMI/ANSI EC57: 2012 standard for cardiac rhythm and ST-segment measurement algorithms. The document then asserts that the device meets these criteria by stating its compliance. However, specific numerical performance results against these criteria are not provided within the given text.
Therefore, a direct table cannot be constructed with numerical performance. The closest interpretation based on the provided text would be:
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| AAMI/ANSI EC57: 2012 Standard | Complies |
| Cardiac Rhythm Measurement Performance | (Specific metrics not provided, but implies compliance with standard) |
| ST-Segment Measurement Algorithm Performance | (Specific metrics not provided, but implies compliance with standard) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The EK12 V2 Algorithm program was designed for compliance with applicable clauses of the following voluntary standard: AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms."
However, the provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) of the data used for the "Performance testing" mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications for the test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers with and without AI assistance.
6. Standalone Performance Study
The document implies that standalone performance testing was conducted. It states, "Performance testing" was a quality assurance measure applied to the development of the system and that "The EK12 V2 Algorithm program was designed... for compliance with applicable clauses of the following voluntary standard: AAMI/ANSI EC57: 2012 – Testing And Reporting Performance Results Of Cardiac Rhythm and St-Segment Measurement Algorithms." This suggests that the algorithm itself was tested against the standard.
However, specific results of this standalone performance are not detailed beyond the statement of compliance.
7. Type of Ground Truth Used
While the standard AAMI/ANSI EC57: 2012 typically involves a precise "ground truth" derived from expert review or more invasive methods for rhythm and ST-segment identification, the document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the testing of EK12 V2.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
§ 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.