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The Coolrail™ linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

The Coolrail Linear Pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.

The provided text is a 510(k) summary for the Coolrail Linear Pen, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria, sample sizes, or ground truth establishment typically associated with a new AI/software-as-a-medical-device (SaMD) submission.

Therefore, the document does not contain the information required to answer the specific questions about acceptance criteria for device performance, study details, sample sizes, ground truth, or multi-reader multi-case studies.

The submission clearly states:

• "Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Coolrail Linear Pen conformance to design controls and specification. Testing determined that the modified Coolrail Linear Pen conformed to design controls and product specifications."
• "The modified Coolrail Linear Pen proposed in this submission is considered substantially equivalent to the Coolrail Linear Pen cleared via K073605. The indications for use, basic overall function, and materials used are substantially equivalent."

This indicates that the device met its internal design controls and product specifications, and its performance was deemed equivalent to the predicate device. However, the specific metrics, statistical methods, and data provenance requested in your prompt are not part of this 510(k) summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, or MRMC studies based on the provided text.

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