(21 days)
The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for:
- 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 lung disease
- 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; and c) dyspnea (shortness of breath).
- Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
- Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
- Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
- Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter
- Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes
The CardioNet ECG Monitor with Arrhythmia Detection Model CN1004 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 (communications Gateway) and 3) a charning Base.
A Sensor acquires two (2) channels of ECG data from the patient's body. This ECG in the Sames Will in the Sensor. When events are detected by the analysis algorithm or when indicated by the patient pressing the event key on the Monitor, the Sensor will upload the data to the Monitor. The ECG data is then uploaded 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.
The provided text describes the CardioNet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1004. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Arrhythmia Detection (General) | The device has the "capability to detect cardiac arrhythmias". No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy for different arrhythmia types) are provided in the document. |
| Compliance with ANSI/AAMI EC 38: 1998 - Ambulatory Electrocardiographs | "Meets the requirements of... ANSI/AAMI EC 38: 1998" |
| Compliance with ANSI/AAMI EC 57: 1998 - Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms | "Meets the requirements of... ANSI/AAMI EC 57: 1998" |
| Compliance with IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety | "Meets the requirements of... IEC 60601-1" |
2. Sample size used for the test set and the data provenance
The document does not provide details on the specific sample size, country of origin, or whether the data was retrospective or prospective for any "test set" demonstrating the device's arrhythmia detection performance. Instead, it refers to compliance with industry standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The substantial equivalence claim is based on compliance with standards, not on a specific clinical performance study against expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document focuses on the device's technical specifications and compliance with performance standards, rather than comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that the proprietary algorithm "resides in the Sensor and detection of events is performed in the Sensor" and that it analyzes the ECG real time. This implies that the algorithm (the "Arrhythmia Detector") operates in a standalone fashion to detect events before trained technicians review the data in the Monitoring Services Application. However, no specific standalone performance metrics (e.g., sensitivity, specificity) for this algorithm are provided in the summarized information, only that it "meets the requirements of" relevant standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document references compliance with "ANSI/AAMI EC 57: 1998 - Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms." This standard typically outlines methodologies for evaluating such algorithms, often involving reference databases with expert-annotated ground truth for various arrhythmias. However, the document does not explicitly state the specific ground truth types used for the testing of this particular device.
8. The sample size for the training set
The document does not provide information regarding the sample size of any training set used for the device's arrhythmia detection algorithm.
9. How the ground truth for the training set was established
The document does not provide information on how the ground truth for any 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.