(80 days)
The Corcam Heart Monitor is a portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia.
- Adult patients who have demonstrated a need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
- Adult patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: dizziness or lightheadedness; syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and dyspnea (shortness of breath).
- Adult patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
- Adult patients who require outpatient monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
The Corcam Heart Monitor is a battery operated, non-invasive, portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia. The device allows for autonomous remote monitoring via a Global System for Mobile Communications/General Packet Radio Service (GSM/ GPRS). The device is connected to the patient via four commercially available electrodes (Derivations I. II. III. and ground) and is equipped with an accelerometer to detect patient falls, GPS for geographical and accurate location of the user, and a speaker system to allow communication to or with the Monitoring Center. A vibrating mechanism and lights, when activated, provide physical and visual signals to the user. Indicator lights also show the operating status of the unit. An SOS/ Help button can be pressed by the user to send a help signal to the monitoring center. In addition to the transmission of patient data to the monitoring center, the monitoring center or clinician at any given moment can conditionally request a new exam on demand allowing for actual and accurate tracking of a cardiac event. Once the monitor detects an irregular heartbeat, the device generates an electrocardiogram (ECG) and sends it to the monitoring center. A clinician in the monitoring center carries out an analysis on the received ECG. Depending upon the analysis of the clinician can check the symptoms of the patient, request another ECG transmission, or initiate immediate assistance for the form of an ambulance/ emergency services.
Here's an analysis of the provided text regarding the Corcam Heart Monitor, outlining its acceptance criteria and the study conducted:
Acceptance Criteria and Device Performance
The provided document describes the Corcam Heart Monitor as meeting performance criteria related to the detection and transmission of ECG data when an irregular heartbeat is detected.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Automated ECG generation and transmission to Central Monitoring Station within a specified timeframe. | "Results showed that in 92% of the cases evaluated, the Central Monitoring Station received the ECGs automatically generated by the Corcam device within 3 minutes. ECGs that took between 4 and 5 minutes to send were generated at peak times, when there is greater data traffic over the cellular network." |
| Ability of the device to detect relevant ECG changes. | "The study concluded that the Corcam Heart Monitor has the ability to detect relevant ECG changes and generate an electrocardiogram and transmit it automatically (without human intervention) within minutes to a Central Monitoring Station." (Note: The study describes what the device does, not a specific accuracy metric for detecting "relevant ECG changes." It implies that it does detect them, as it generates an ECG when an "irregular heartbeat" is detected.) |
| Absence of adverse events during use (implied safety aspect). | "There were no adverse events." |
| Compliance with various electromedical equipment and wireless communication standards (non-clinical performance). | The device meets requirements of numerous standards, including NBR IEC 60601-1, ABNT NBR IEC 60601-1-2, ABNT NBR IEC 60601-2-27, IEC 62209-01, IEC 62209-02, IEEE Std 1528, ETSI TS 151 010-1, AAMI / ANSI EC38, and AAMI/ANSI EC 57. |
Study Information
The document describes a clinical study to assess the accuracy and performance of the Corcam Heart Monitor.
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Sample size used for the test set and the data provenance:
- Sample Size: 152 consecutive patients.
- Data Provenance: The study was conducted from May to August 2012, involving "inpatients or outpatients with established clinical diagnoses (as reported in medical records)". The sponsor is based in São Paulo, Brazil, suggesting the data is likely from Brazil. It is a prospective observational study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth ("conventional ECG") was analyzed by a "clinician in the monitoring center" at a "Central Monitoring Station" after the Corcam device transmitted the ECG. It's unclear how many clinicians were involved in establishing the "ground truth" for the conventional ECG, or their specific qualifications. The document states a "clinician" carries out an analysis, implying perhaps one per case, but doesn't specify a number for the overall ground truth establishment.
- Qualifications: "Clinician in the monitoring center." No specific qualifications (e.g., years of experience, board certification) are provided.
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Adjudication method for the test set:
- Not explicitly stated. The study compares the Corcam device's ECG to "conventional ECG (gold standard)" which implies the conventional ECG served as the reference. There's no mention of multiple readers for the conventional ECG or a specific adjudication process to resolve discrepancies.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study compares the device's automatic transmission capability and detection of relevant ECG changes against a "conventional ECG (gold standard)," not the performance of human readers with vs. without AI assistance from the Corcam device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance aspect was evaluated regarding the device's automated function. The device "automatically generated and sent an ECG to the Central Monitoring Station without human intervention, either from the patient or the investigator." The performance metric reported (92% of cases received within 3 minutes) directly relates to this standalone, automatic functionality. The subsequent analysis by a "clinician" suggests a human-in-the-loop for interpretation, but the detection and transmission itself is standalone.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established using conventional electrocardiography (ECG), referred to as the "gold standard." This conventional ECG was then analyzed by a "clinician in the monitoring center." Thus, it's essentially expert interpretation of conventional ECGs.
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The sample size for the training set:
- The document does not provide any information regarding a training set size. The described "Performance Data (Clinical)" section details a single clinical study that appears to serve as the test set for performance evaluation. This suggests the device might have been developed using internal data or prior knowledge, but explicit details on a training set are absent.
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How the ground truth for the training set was established:
- As no training set is described, there is no information provided on how its ground truth 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.