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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 CN1005 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.

The provided document is a 510(k) premarket notification for the CardioNet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1005. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain the detailed acceptance criteria or the specific study results proving the device meets those criteria.

The "Summary of Performance Testing" section broadly states that the device meets the requirements of certain performance standards (ANSI/AAMI EC 38:1998, ANSI/AAMI EC 57:1998, and IEC 60601-1), but it does not provide the specific metrics or the actual performance data from any particular study.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the document.
• Sample size used for the test set and the data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
• Adjudication method for the test set: Not specified.
• 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: Not specified. This device is an arrhythmia detection algorithm, not explicitly marketed as AI assistance for human readers in the context of an MRMC study described.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states data is analyzed by an automated algorithm and then reviewed by trained technicians, implying human-in-the-loop, but specific standalone performance data is not provided.
• The type of ground truth used: Not specified.
• The sample size for the training set: Not specified.
• How the ground truth for the training set was established: Not specified.

The closest information related to performance is the mention of adherence to standards like ANSI/AAMI EC 57:1998, which outlines methods for "Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms." To find the specifics of the acceptance criteria and study results, one would need to refer to the full 510(k) submission, which is not provided in this document.

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