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The Devon 52 Series Sequential Compression Device is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions:

• Lymphedema
• Venous stasis ulcers
• Venous insufficiency
• Peripheral edema

The Devon 52 Series Sequential Compression Device is a compression device based on sequential pneumatic compression technique.

This document is a 510(k) clearance letter for the Devon 52 Sequential Compression Device, which is a medical device. It does not contain information about acceptance criteria, device performance, or studies in the way you've requested for an AI/software device.

Specifically, the document refers to a physical medical device (compressible limb sleeve) that operates based on a "sequential pneumatic compression technique" for treating conditions like Lymphedema and Venous stasis ulcers. It is not an AI/software device and therefore does not have the types of studies, ground truth establishment, or performance metrics typically associated with AI model validation.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance, as these are not relevant to the content of this 510(k) clearance letter for a physical medical device.

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