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This device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; Dizziness, Palpitations, Syncope, Chest pain.

The King of Hearts® Express + AF Monitor is an triggered cardiac event recorder designed for auto diagnostic evaluation of transient symptoms. The device uses a two-wire single channel lead set for event recording. Using looping memory, the device captures ECG data; auto triggering after the patient experiences a cardiac symptom or manually after the patient pushes the RECORD button. The number of Events can be physician adjusted according to the programmed lengths of Before and After data acquisition duration for each recording. These segments of stored ECG can then be transmitted later in the form of an FM-modulated acoustic tone, when the SEND button is manually depressed. The device is configured in the same compact sized case approximately 4 inches long, 2 % inches wide and 5/8 " thick as the predicate devices. The two wire lead set is the same as is used in the predicate device [King of Hearts Express Monitor (K920984)}.

The provided text describes the "King of Hearts® Express + AF Monitor," and its 510(k) submission for FDA clearance. However, it does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, sample sizes for testing or training, ground truth establishment, or multi-reader multi-case study information.

The document primarily focuses on:

• Identifying the device and its intended use.
• Stating its equivalence to predicate devices.
• Highlighting the addition of atrial fibrillation (AF) detection as a key modification.
• Confirming that the modifications do not impact safety and effectiveness.

Therefore, I cannot fulfill the request for a detailed table and study description based on the provided input. The document explicitly states: "The King of Hearts Express + AF Monitor is Safety and Effectiveness: considered safe and effective for use when used in accordance with the instructions provided in the Owners Manual which accompanies each device. This device is a modification of previously cleared products currently manufactured by Instromedix. The only modifications are stated above. Based on these minor changes, there is no impact on safety and effectiveness." This indicates that extensive new studies for safety and effectiveness, beyond demonstrating the new AF detection feature, were likely not required for this 510(k) given the device's predicate status and the nature of the modification.

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