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The Cardiac Trigger Module model CTM-300 is intended for use on patients requiring Rwave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT and SPECT/CT.

The CTM-300 is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.

The Cardiac Trigger Module model CTM-300 is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Cardiac Trigger, Model CTM300." It does not include detailed information about acceptance criteria or specific study results to prove device performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than providing a performance study report.

The information you are asking for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in the 510(k) summary or the full 510(k) submission, which is not provided here.

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