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The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare professionals, and patients who are under medical supervision, in treating conditions such as:

• · Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
• · Reduction of pain and swelling after injury and surgery
• · Enhancement of venous circulation
• · Prevention of venous stasis
• · Assistance in healing of cutaneous ulcers
• · Reducing edema
• · Treatment of chronic venous insufficiency
  The device is intended for hospital, home and clinic use

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I apologize, but the provided text from the FDA 510(k) clearance letter for the "Phlebo Press DVT Model 760D" does not contain information about acceptance criteria or a study proving the device meets those criteria.

This document is a standard 510(k) clearance letter, which states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device. It briefly mentions the indications for use but does not delve into the specific performance data, clinical trials, or validation studies that would include acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text. To answer your question, information from the actual 510(k) submission (which includes performance data, clinical data, and testing protocols) would be needed, not just the clearance letter.

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