(170 days)
The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for:
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- Patients who have a demonstrated need for cardiac Monitoring. These may include but are not limited to patients who require Monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic fung disease.
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- Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded: c) dyspnea (shortness of breath).
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- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
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- Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
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- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia Monitoring.
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- Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
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- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
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- Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter
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- Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation).
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- Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.
The CardioNet ECG Monitor with Arrhythmia Detection CN1006 is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a CardioNet staffed monitoring center.
The subject device is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base.
A Sensor acquires the ECG signal from the patient's body and transmits the signal to PDA sized monitor where the data is stored and analyzed by an automated arrhythmia analysis algorithm residing in the Monitor. When events are detected by the analysis algorithm or when indicated by the patient pressing the event key on the Monitor, the Monitor will transmit the data to the Monitoring Center. Data can be uploaded to the Monitoring Center in a variety of ways -Transmitted via Cellular RF modem or via RF to the Base for transmission via the patient's landline telephone. The data is received and reviewed by trained technicians using the Monitoring Services Application.
This document describes the CardioNet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1006.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CardioNet ECG Monitor with Arrhythmia Detection are based on various performance standards. The document states that the "subject device meets the requirements of the following performance standards in accordance with Class II Special Controls Guidance document: Arrhythmia Detector and Alarm." No specific numerical acceptance criteria or detailed device performance metrics are provided in the document beyond this general statement.
The performance standards met are:
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| AAMI/ANSI EC 57 1998/(R) 2003 - Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms | Meets requirements |
| AAMI EC 53/(R) 2001 ECG Cables and leadwires | Meets requirements |
| International Electrotechnical Commission (IEC) 60601-1:1988 +A1:1991 +A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety | Meets requirements |
| IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001) | Meets requirements |
| AAMI / ANSI EC38:2007, Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular) | Meets requirements |
| AAMI / ANSI / ISO 10993-1:2003, Biological evaluation of medical devices -- Part 1: Evaluation and testing. (Biocompatibility) | Meets requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not expressly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to complying with the listed performance standards, which would imply that the device was tested against relevant data as prescribed by those standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Given the reference to AAMI/ANSI EC 57, which often involves expert review of arrhythmias, it is likely that experts were involved, but details are not provided.
4. Adjudication Method for the Test Set
The adjudication method for the test set is not mentioned in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was performed, nor does it discuss the effect size of human readers with vs. without AI assistance. The device is an "Ambulatory ECG Monitor with Arrhythmia Detection," implying an automated detection system primarily, rather than an AI-assisted human reading system.
6. Standalone (Algorithm Only) Performance Study
The information provided suggests that a standalone performance study of the algorithm was conducted, as the device is described as having an "automated arrhythmia analysis algorithm residing in the Monitor" and the "subject device meets the requirements of the following performance standards in accordance with Class II Special Controls Guidance document: Arrhythmia Detector and Alarm." Compliance with standards like AAMI/ANSI EC 57 typically involves evaluating the performance of the algorithm itself. However, explicit details of a standalone study (e.g., specific metrics and experimental setup) are not provided beyond the statement of compliance with standards.
7. Type of Ground Truth Used
The document implies that the ground truth for evaluating arrhythmia detection would be established according to the methodologies defined by the AAMI/ANSI EC 57 standard, which often involves expert consensus on annotated ECG recordings. For other aspects, like biocompatibility (ISO 10993-1), the ground truth would relate to biological responses. No specific details are given, but compliance with these standards points to established scientific methods for ground truth creation.
8. Sample Size for the Training Set
The document does not provide information about the sample size used for the training set of the arrhythmia detection algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does not detail 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.