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For patient’s who may be experiencing cardiac events symptomatic pulse rate abnormalities.

TRACER

The provided text is a 510(k) premarket notification approval letter from the FDA for a device named "TRACER." It does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the requested table and study description based on the provided text.

The document primarily focuses on:

• The FDA's decision that the TRACER device is substantially equivalent to legally marketed predicate devices.
• Regulatory classification (Class II, product code MJW).
• General controls and potential additional controls (Special Controls or Premarket Approval) applicable to the device.
• Contact information for various FDA offices.
• A brief mention of "Indications For Use" on the enclosure, which is not fully visible, but hints at cardiac events and symptomatic pulse rate abnormalities.

To provide the requested information, a document specifically detailing the pre-market studies and their results would be needed.

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