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The SherpaPak™ Pancreas Transport System is intended to be used for the static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ. The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

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This looks like a 510(k) clearance letter for the Paragonix SherpaPak Pancreas Transport System. As such, the information you've requested about acceptance criteria and study details (like sample size, number of experts, ground truth, etc.) is typically not found directly within the clearance letter itself.

A 510(k) clearance is about demonstrating substantial equivalence to a predicate device, not necessarily extensive clinical performance studies like those required for a PMA (Premarket Approval). The FDA reviews the provided data (which might include bench testing, engineering reports, and sometimes limited clinical data or literature reviews) to determine if the new device is as safe and effective as a legally marketed predicate device.

Therefore, based solely on the provided text, I cannot extract the specific details you've asked for. The document primarily outlines the FDA's regulatory decision and standard disclaimers.

However, I can tell you the stated "Indications for Use" which implicitly sets the performance envelope for the device:

• Intended Use: Static hypothermic preservation of pancreas organs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with this organ.
• Performance Claim: The SherpaPak™ Pancreas Transport System can maintain the donor organ storage temperature between 4º C and 8º C up to 21 hours.

To get the detailed information you're looking for (acceptance criteria, study design, sample sizes, ground truth establishment, etc.), you would typically need to refer to:

• The original 510(k) submission document: This is a comprehensive package submitted by the manufacturer to the FDA. It contains all the bench testing, performance data, and other information used to support the substantial equivalence claim. This is usually not publicly available in full detail.
• Any associated clinical trial publications: If the manufacturer performed any studies (even limited ones for 510(k), or more extensive ones for other regulatory purposes or marketing), they might be published in scientific journals.
• The manufacturer's official documentation: User manuals, technical specifications, and marketing materials might provide some of this performance data.

In summary, the provided FDA letter does not contain the detailed study information you're seeking. It confirms the clearance of the device and its intended use and a key performance parameter (temperature range and duration).

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