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The PER is indicated for use by patients as directed by a physician, who experience transient symptoms that may suggest cardiac arrhythmia, conduction abnormalities or other rhythm disturbances that may result in shortness of breath, pre-syncope or palpitations.

The PER is a battery operated transtelephonic ECG event recorder and transmitter that is capable of storing multiple electrocardiograms and the transmission of these recordings by telephone to a receiving system. The PER stores the ECG before and after the `record' button is depressed. The recording period is preset up to 80 seconds with 2 recordings stored. The stored ECGs are transmitted by acoustic output by coupling the telephone mouthpiece over the PER

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a transtelephonic ECG event recorder (PER). It focuses on substantial equivalence to a predicate device, KING OF HEARTS® EXPRESS (K920984), rather than a detailed performance study with specific acceptance criteria that would include metrics like sensitivity, specificity, or accuracy derived from a test set and ground truth.

The document mentions:

• Comparison of Electrical Characteristics and Data Transmission: This indicates a comparison was done to show the PER's performance in these areas was equivalent or better than the predicate. However, it does not provide specific acceptance criteria or results in a table format.
• Summary of Safety: This references compliance with various safety and EMC standards (e.g., IEC 60601-1, IEC 60601-1-2, AAMI EC11:1991). This confirms the device meets these standards, but these are general safety and performance standards for the device type, not specific acceptance criteria for a clinical study validating diagnostic accuracy.
• Risk Analysis: Discusses failure modes and mitigation, but not performance against clinical acceptance criteria.

Therefore, I cannot provide the requested table, sample sizes for test/training sets, details about expert ground truth, adjudication methods, MRMC studies, standalone performance, or how training ground truth was established, as this information is not present in the provided text.

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