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The indications for use for the PocketECG v3 monitor are as follows:

1. 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
2. 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)
3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms.
4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring
6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias
7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter.
8. 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 OT interval changes.

PocketECG v3 - Medicalgorithmics Unified Arrhythmia Diagnostic System is an ambulatory ECG monitor which analyzes electrographic signal, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and the entire ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff.

This appears to be a 510(k) summary for the PocketECG v3 device. Unfortunately, the provided text does not contain any information about acceptance criteria or specific study results demonstrating the device meets those criteria.

The document primarily focuses on:

• Device identification: Names, classification, product codes.
• Substantial equivalence: Listing predicate devices and comparing similarities and differences.
• Indications for Use and Contraindications.
• Referenced standards: IEC, AAMI/ANSI, ISO.
• FDA correspondence: The final pages show the FDA's decision letter.

To fully answer your request, information regarding performance studies, acceptance criteria, sample sizes, ground truth establishment, and expert qualifications would need to be present in a different section of the 510(k submission, likely a dedicated "Performance Testing" or "Clinical Performance" section, which is not included in the provided text.

Therefore, I cannot generate the table or provide the detailed study information you requested based on the given input.

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