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The Boehringer Laboratories, Inc. Pneumatic Ambulatory Compression System (PACS™) is indicated for the application of controlled pressure to the lower extremities in order to prevent blood pooling in the lower venous leg. Pooling of blood in the legs is associated with: venous insufficiency, edema, lymphedema, active venous ulcers, healed venous ulcers, pronounced varicosities and post-thrombotic syndrome. The PACS™ is to be used on the order of a Physician.

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The provided text is a 510(k) clearance letter from the FDA for the Boehringer Laboratories Pneumatic Ambulatory Compression System (PACS). This document primarily focuses on establishing substantial equivalence to a predicate device and regulatory compliance.

It DOES NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested table and details based on the given input. The document is strictly a regulatory clearance and does not include the technical performance data that would typically be found in a study report.

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