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The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following:
Indications for Use:

• Management of the symptoms of post thrombolytic syndrome (PTS)
• Prevention of deep vein thrombosis (DVT)
• Prevention of primary thrombosis
• Treatment of lymphedema
• Diminishing post-operative pain and swelling
• Treatment of leg swelling due to vascular insufficiency
• Treatment of varicose veins
• Treatment of chronic venous insufficiency
• Enhancing blood circulation
• Treatment of intermittent claudication

The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion, and when worn below the knee strapped firmly to the calf, result in compression of the calf and consequently, an increased upward volumetric displacement of venous and lymph fluid. Each of the models within the family (VW5-6;VW5-10; VW5-20; and VW5-30) is distinguished by the maximum number of times the wave plate cycles each minute (6, 10, 20 and 30 cycles/minute respectively). Clinical preference to choose a specific frequency of motion for each specific patient based upon that patient's clinical symptoms, severity of disease, and perceived compliance with treatment has been the motivation for creating each model within the series.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) premarket notification decision letter from the FDA for the Venowave VW5 device.

It primarily focuses on:

• Substantial Equivalence: The FDA's determination that the Venowave VW5 is substantially equivalent to a legally marketed predicate device (K073028).
• Device Description and Intended Use: Details about the device's function as a peristaltic pump to improve vascular and lymphatic flow in lower limbs, and its intended uses (e.g., prevention of DVT, treatment of lymphedema).
• Comparison to Predicate: A table outlining updates and changes made to the device compared to the predicate, such as specified contraindications, design changes, and battery type.
• Summary of Testing: A brief list of performance testing conducted (Software Verification, EMC, Electrical Safety Drop Test, Battery Testing) with "Pass" results.

The document does not provide:

1. A table of specific acceptance criteria (e.g., "Device must achieve 90% accuracy in detecting X") and reported performance metrics against those criteria.
2. Details on sample size, data provenance, expert ground truth establishment, or adjudication methods for any clinical study.
3. Information on multi-reader multi-case studies or standalone algorithm performance.
4. Details on the type of ground truth used or the sample size/establishment of ground truth for a training set.

The "Summary of Testing" section lists general performance tests (Software, EMC, Safety, Battery) which are typically engineering or non-clinical tests, not clinical performance studies with acceptance criteria relevant to medical diagnosis or treatment effectiveness.

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