(28 days)
The Cardio WiFi Electrocardiograph is a small portable digital cardiograph intended for use by medical professionals to acquire 12-lead ECG's from single or multiple patients in a clinical or point of care setting. ECG data is first recorded to a secure digital flashcard and then transferred to an ECG management system for review by a physician or other qualified professional.
The Cardio WiFi electrocardiograph continuously records data to a flashcard and displays it at high resolution. It features a large, liquid crystal display ("LCD") that allows a medical professional to periodically check the test subject's full, 12-lead ECG, either at intervals or in the event of a patient symptom. The device is portable and is battery-powered. Data is stored for later review at an ECG review station. Data transfer is accomplished via WLAN 802.11 b or g.
This device, the Datrix Cardio WiFi Electrocardiograph, is a portable electrocardiograph without analysis capabilities. As such, the submission primarily focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from applicable standards) | Reported Device Performance |
|---|---|
| AAMI EC11 (Performance Requirements for Diagnostic Electrocardiographs) | Successfully tested and met acceptable results. |
| IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Successfully tested and met acceptable results. |
| IEC 60601-1-2 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests) | Successfully tested and met acceptable results. |
| IEC 60601-2-25 (Medical Electrical Equipment - Part 2-25: Particular Requirements for the Safety of Electrocardiographs) | Successfully tested and met acceptable results. |
| Performance, Functionality, and Reliability Characteristics | Followed established test procedures in a quality system, with acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance:
This submission did not involve a clinical study with a "test set" in the traditional sense of evaluating diagnostic accuracy or a human-in-the-loop performance. Instead, the evaluation was based on non-clinical testing to established international and national standards for electrocardiographs. Therefore, there is no sample size of patient data or provenance information to report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The ground truth for this type of device (a data acquisition device without analysis) is adherence to established engineering and performance standards, not diagnostic accuracy. Therefore, no experts were used to establish ground truth from patient data.
4. Adjudication Method for the Test Set:
Not applicable. There was no clinical test set requiring adjudication of patient data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This device is a basic electrocardiograph without analysis, meaning it does not incorporate Artificial Intelligence (AI) for interpretation or diagnostic assistance. Therefore, no MRMC study was conducted to evaluate human reader improvement with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device does not have an "algorithm" for diagnostic interpretation in the sense of AI. It acquires and stores ECG data. The performance evaluation was based on the device's ability to accurately and safely perform its intended function of acquiring ECG data, not on the performance of a standalone algorithm for diagnosis.
7. The Type of Ground Truth Used:
The ground truth used for this submission was based on established engineering and performance standards for electrocardiographs, specifically:
- AAMI EC11
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-25
- Internal quality system test procedures for performance, functionality, and reliability.
8. The Sample Size for the Training Set:
Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable as there is no training set.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).