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The A-V Impulse System foot pump is safe and effective for the following indications. The proper duration for use of each indication is subject to the clinical judgment of the prescribing physician. Recommended Guidelines are as follows: Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Acute, Edema -- Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis/Venous Insufficiency.

The ClearMedical/Novamedix reprocessed AVIs are a noninvasive prophylaxis for reducing the incidence of deep vein thrombosis. These AVIs are used by adult patients in hospital or home settings. The AVIs are latex-free, cushioned throughout, and cover maximum foot surface area to distribute pressure evenly over the foot and minimize trauma to untreated areas. The right foot cover is designated with blue graphics, the left with red graphics. The AVIs have a rigid sole that contains and directs the impulse (simulates the ground) against the venous plantar plexus (network of veins at the sole of the foot). They also have an anatomically shaped bladder that completely covers the plantar plexus. Both the rigid sole and bladder ensure that the venous plantar plexus is completely flattened and stretched (causing the plantar plexus to collapse and empty, which sends a column of blood to the right atrium of the heart) during impulse pumping. The AVIs have two Velcro hook straps to allow secure fastening, vent holes and a polyethylene tube.

The provided text is a 510(k) summary for the ClearMedical/Novamedix Arterial Venous Impulse (AVI) Foot Covers, a reprocessed medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

The 510(k) summary explicitly states: "Based on an assessment of bench tests and non-clinical performance data, we believe that in all relevant safety and performance indicators the ClearMedical/ Novamedix AVIs demonstrates substantial equivalence to the predicate devices, the Novamedix AVIs."

Therefore, the document does NOT contain information regarding:

• A table of acceptance criteria and the reported device performance: The document discusses "technological indicators of substantial equivalence" like infection control, fit/attachment, bladder function, and velcro adhesion, but it does not provide specific quantitative acceptance criteria or detailed performance data against these. The only performance metric mentioned is related to infection control, where ClearMedical's methods are stated to "meet or exceed the CDC and APIC Guideline for Handwashing and Hospital Environmental Control, 1985, and APIC Guideline for Selection and Use of Disinfectants standards for this class of device."
• Sample sizes used for the test set and data provenance: The document mentions "bench tests and non-clinical performance data" but provides no details on samples sizes, country of origin, or whether the data was retrospective or prospective.
• Number of experts used to establish the ground truth and their qualifications: Not applicable as there is no specific study described that required expert-established ground truth.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not performed or mentioned.
• Standalone (algorithm only without human-in-the loop performance) study: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable as there is no specific study described that required ground truth.
• Sample size for the training set: Not applicable as this is a reprocessed physical device, not an AI algorithm.
• How the ground truth for the training set was established: Not applicable.

In essence, the 510(k) summary relies on establishing substantial equivalence through comparison of technological characteristics and adherence to existing standards, rather than proving a device meets specific performance criteria through a clinical study.

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