(63 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 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. When an arrhythmic event is defected the monitor can transmit the ECG data to the monitoring center utilizing a cellular modem or telephone data line. The patient can also initiate the recording and transmission of ECG data if symptoms are felt. The data is received and reviewed by trained technicians using the Monitoring Services Application.
Here's a breakdown of the acceptance criteria and study information for the CardioNet Ambulatory ECG Monitor with Arrhythmia Detection, Model 1002, based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. However, it states that "Performance testing was performed in accordance with FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" and that "The CardioNet Ambulatory ECG Monitor meets or intends to conform to the applicable standards suggested in the guidance document including:
- ANSI/AAMI EC 38: 1998 Ambulatory Electrocardiographs
- ANSI/AAMI EC 57: 1998 Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
- International Electrotechnical Commission (IEC) 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety"
Therefore, the acceptance criteria would be the specific quantitative and qualitative performance requirements outlined in these standards and the FDA guidance document for arrhythmia detectors. Without access to the full submission or these detailed standards, a precise table cannot be generated.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance testing was performed..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications for establishing ground truth 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. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss the effect size of human readers improving with or without AI assistance. This study appears to be focused on the standalone performance of the device's arrhythmia detection algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was indicated. The document states: "The CardioNet ECG Monitor with Arrhythmia Detection differs from the predicate device only with respect to the arrhythmia analysis algorithm. The predicate device included an arrhythmia analysis algorithm licensed from Mortara Instrument. The new algorithm was developed by CardioNet and includes the same functions supplied by the previous algorithm." This implies that the performance testing described was primarily to validate the new, standalone arrhythmia analysis algorithm developed by CardioNet. The device transmits data to a "CardioNet staffed monitoring center" where data is "reviewed by trained technicians," suggesting human-in-the-loop for clinical use, but the performance testing refers specifically to the algorithm's capability.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state the type of ground truth used. For arrhythmia detection, it is common to use expert-annotated ECG recordings, often involving multiple cardiologists or electrophysiologists to establish consensus.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set for the CardioNet-developed algorithm.
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.