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The VenaPro Vascular Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:

• Aid in the prevention of DVT;
• Enhance blood circulation;
• Diminish post-operative pain and swelling;
• Reduce wound healing time;
• Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.

The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

The VenaPro Vascular Therapy System is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT).

The system utilizes pneumatically controlled, single chamber cuffs actuated by an electronically controlled air pump unit and solenoid valve. All pump, battery and control components are protectively housed in a plastic case that is permanently attached to a single use inflatable cuff. A single tactile touch control switch, tri-color LED for ON, LOW BATTERY, CHARGING and CHARGE COMPLETED indication, and a blue LED (for indicating a leak or low pressure alarm) provides for user interface. There is also a port for connecting the battery charger/AC adapter plug, and a currently unused port for future use in usage data reporting.

The leg wrap (cuff) component consists of a Polyvinyl Chloride (PVC) air bladder encased inside a soft, non-woven medical fabric (a Polyester blended medical fabric) or equal , which is adhered to the PVC air bladder. The units are supplied clean, non-sterile, packaged in pairs (1 left and 1 right side).

In operation, the user simply turns the power ON via the single button I/O control switch. A single user "cuff" containing air bladders is permanently connected to the unit. The control unit then fills the cuff to a pre-determined pressure (50 mmHg). Cuff pressure is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned OFF for an approximately 50 second "rest" period, and the cuff deflates to ambient pressure through a valve inside the plastic case. After the "rest" period, the cycle repeats until the unit is turned off.

The provided text describes a 510(k) premarket notification for the VenaPro Vascular Therapy System, arguing for its substantial equivalence to a previously cleared predicate device (K133274). The document does not describe a study involving human readers or AI assistance, nor does it specify acceptance criteria for clinical performance. Instead, it focuses on non-clinical testing and a comparison of the device's technical characteristics with its predicate.

Therefore, many of the requested pieces of information are not present in the provided document.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for clinical performance. Instead, it focuses on demonstrating equivalence to a predicate device through technical specifications and non-clinical testing. The "performance" reported is primarily that the subject device meets the same specifications, functions, and safety standards as the predicate.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This submission is for a medical device (compressible limb sleeve system) where substantial equivalence is demonstrated through comparison of technical specifications and non-clinical engineering tests, not a clinical study involving a "test set" of patient data for performance evaluation in the context of an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. As above, no clinical "test set" requiring expert ground truth was described for this type of device submission.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical "test set" requiring adjudication was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This document concerns a physical medical device (VenaPro Vascular Therapy System), not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI assistance comparison was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This is not an AI device.

7. The type of ground truth used

The concept of "ground truth" as it applies to AI/software performance in image interpretation or diagnosis is not relevant here. The "truth" for this submission is based on adherence to engineering standards and technical specifications proven safe and effective by the predicate device.

Specifically, non-clinical tests were performed to assure conformance with:

• ANSI AAMI ES60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
• IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
• IEC 60601-1-11 "Medical Electrical Equipment Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment".
• IEC 62133-2 "Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes -Safety Requirements For Portable Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems".
• Bench tests for physical, electrical, and performance requirements.
• Software verification according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI device.

9. How the ground truth for the training set was established

Not applicable/Not provided. This is not an AI device.

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