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The Vasculaire Compression System is indicated for use in:

• Preventing deep vein thrombosis (DVT)
• Enhancing blood circulation
• Diminishing post-operative pain and swelling
• Reducing wound healing time
• Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
• Treatment of chronic venous insufficiency
• Reducing edema

The Vasculaire Compression System is a mobile, intermittent pneumatic compression system intended to provide sequential compression therapy to the patient's lower limb(s). The Controller is battery powered, provides selectable compression cycles and system monitoring of the compression therapy. The Sleeves are provided in a foot & calf or a calf only configuration for selectable lower limb(s) compression therapy.

The Vasculaire Compression System includes three components: the Controller, the Sleeve and the Charger.

The Sleeve is a multiple-cell bladder intended to be attached directly to the lower limb(s). It is intended to provide compression to the tissue surrounding the vasculature. The Sleeve is provided in two configurations. The first configuration is a foot and calf Sleeve that provides sequential compression to the foot and calf. The second configuration is a calf only Sleeve that provides sequential compression to the calf. The Controller is connected to the Sleeve using two flange ports and can be mounted directly onto the Sleeve for a fully mobile system. The flange ports allow the air from the Controller to effect compression on the foot and calf zones independently. The Controller allows the user to select between foot and calf compression or a calf only compression. The Controller also allows the user to select compression cycles of approximately one to three cycles per minute. The Controller is a lightweight (less than 1 Ib.), battery-powered, electromechanical control unit intended to provide and monitor the inflation cycle for enhanced circulation therapy. The Charger consists of a medical grade power supply and the table top docking station.

The provided text describes a 510(k) submission for the Vasculaire Compression System, which is a mobile, intermittent pneumatic compression system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than robust, clinical performance studies with detailed acceptance criteria as one might see for novel technologies. Therefore, many of the requested details about acceptance criteria, specific study designs, and ground truth are not present in this summary.

Based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the manner typically associated with clinical efficacy or diagnostic accuracy studies. Instead, it lists the types of testing conducted to support substantial equivalence.

Note: The document explicitly states, "There is no FDA performance standard required for the Vasculaire Compression System." This implies that the 'acceptance criteria' were primarily internal benchmarks derived from the predicate devices and relevant industry standards for safety and basic functionality.

2. Sample Size for the Test Set and Data Provenance

The document does not describe a clinical "test set" in the context of human subjects or patient data. The testing mentioned (bench testing, software verification, etc.) would be performed on the device itself or its components. Therefore, information on sample size and data provenance (country, retrospective/prospective) is not applicable or provided for such testing.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided. The testing described does not involve expert adjudication or ground truth establishment by clinical experts in the sense of reviewing patient data. The 'ground truth' for bench testing would be the engineering specifications and established standards.

4. Adjudication Method

Not applicable and not provided. There was no clinical data requiring adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The submission is for a physical medical device (compression system), not an AI or imaging diagnostic tool that would typically involve a multi-reader study. The stated purpose of the 510(k) is to demonstrate substantial equivalence to predicate devices based on safety and performance characteristics, not to quantify improvements in human reader performance with AI assistance.

6. Standalone Performance Study (Algorithm Only)

Not applicable and not provided. The device is a physical medical system, not a software algorithm or AI model that would have a standalone performance.

7. Type of Ground Truth Used

For the various bench and engineering tests, the "ground truth" would be established by:

• Engineering Specifications: Designed parameters for airflow, pressure, leakage, etc.
• Industry Standards: Requirements specified in ISO, IEC, and BS EN standards for medical devices (e.g., electrical safety, electromagnetic compatibility, biocompatibility).
• Predicate Device Characteristics: Performance parameters of the legally marketed predicate devices to which the Vasculaire System is claiming substantial equivalence.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this device's testing.

8. Sample Size for the Training Set

Not applicable and not provided. This device is not an AI/ML system that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable and not provided, as there is no training set for this device.

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