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The ZEROVENO device induces improved vascular and lymphatic flow of the lower limbs. The device is intended to treat the following:

• Management of the symptoms of post thrombotic syndrome (PTS)
• Prevention of deep vein thrombosis, (DVT)
• Treatment of lymphedema
• Treatment of leg swelling due to vascular insufficiency
• Treatment of varicose veins
• Treatment of chronic venous insufficiency

ZEROVENO is a product designed to distribute the pressure applied to the leg by changing the position of the contact part which supports the load of the leg alternately with the pressing pressure periodically.
The swept volume or volume of blood or lymph fluid displaced upwards for each cycle is the product of the wavelength (14cm), the width of the wave sheet (8cm) and the depth of the wave (1cm) or approximately 0.1 L/cycle.
ZEROVENO has a maximum continuous operation time of 20 hours on a low-speed basis when the built-in lithium-ion battery is fully charged.

The provided text describes a 510(k) premarket notification for the "ZEROVENO" device. It outlines the device's characteristics and compares it to a predicate device. However, it does not contain information related to acceptance criteria for objective performance metrics (e.g., sensitivity, specificity, AUC) or a clinical study proving the device meets said acceptance criteria.

Instead, the performance data section refers to:

• Non-clinical data: This supports the safety of the device.
• Hardware and software verification and validation: These demonstrate the ZEROVENO should perform as intended.
• Mechanical testing: This includes pressing pressure, maximum pressing height, pressing cycle duration, and pressing range.

The comparison table (Table. Comparison of Technology Characteristics) primarily focuses on technical specifications, operational principles, and indications for use, showing substantial equivalence to the predicate device, not performance against specific clinical acceptance criteria.

Specifically, the document states:
"The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate the ZEROVENO should perform as intended in the specified use conditions. Therefore, the ZEROVENO is substantially equivalent to the predicate device."

This indicates that the submission relies on demonstrating technical performance and substantial equivalence rather than a clinical study with acceptance criteria for device accuracy or effectiveness against a specific ground truth.

Therefore, I cannot populate the requested table and information as it is not present in the provided text.

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