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The Plexus SCD 110 DVT Sleeve is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, obstetric conditions and treatments.

The Plexus SCD110 Sequential Compression Device is a non-sterile sequential compression sleeve intended to be used with commercially-available compression pumps*. The device is used to prevent the onset of deep vein thrombosis (DVT) by stimulating blood flow and increasing venous flow velocity. The device consists of a pair of soft pressure garment sleeves with an internal air bladder. Each package of Plexus SCD110 has two compression sleeves – one for the right calf and one for the left calf.

The Plexus SCD110 is a single-bladder sleeve that provides a preset pattern of intermittent pressure to the deep vein in the lower leg. To use the device, the garment sleeve is wrapped around a patient's calf. The compression sleeve is connected to a commercially available DVT compression pump intended to be used with single-chamber air bladder sleeves. The connector of the sleeve is designed such that it will not connect to a pump intended for multi-chamber sleeves. When the compression pump is turned on, air flows from the air pump into the air bladder inside the compression sleeve, providing pneumatic pressure on the calf muscle and veins underneath.

Once the compression pump reaches an air pressure of 40 mmHg), a relief valve is triggered within the DVT pump to let air escape from the sleeve and reduces the pressure within the system. With the relief valve opened, the compression sleeve completely deflates and allows blood to re-enter the deep veins of the patient during this cycle. After a pre-set deflation period (~50-second cycle), the relief valve will close and the air pump will start pumping again to 40 mmHg. This cycle of inflation of the air bladder will continue until the compression pump device is turned off.

The Plexus SCD110 sleeve is made of a soft, lightweight, non-woven foam-felt material with a singlechamber bladder made of polyvinyl chloride (PVC). The Plexus SCD sleeve is intended to be compatible with single-chamber DVT pump systems only and the connectors will not allow the sleeve to be attached to any other compression systems (i.e. multi-chamber DVT systems, lymphedema compression systems)

The provided document is a 510(k) summary for the Plexus SCD110 Sequential Compression Device Sleeve. It details the device's intended use, technical characteristics, and performance data to demonstrate substantial equivalence to a predicate device. However, the document does NOT contain information about acceptance criteria and a study that proves the device meets those criteria in the way typically discussed for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a specified threshold).

The performance data mentioned in this document focuses on biocompatibility and functional tests to ensure the device performs as intended and is safe. These are engineering-focused tests rather than clinical performance studies using patient data.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to the type of information presented in this 510(k) summary for this specific device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by "Passed" and "Equivalent" to predicate device):

Note: The exact numerical acceptance criteria for "Passed" are not explicitly detailed in this summary but are understood to be met based on the "Passed" result and declaration of equivalence to predicate devices, which would have established similar benchmarks.

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

• Not Applicable. This document describes engineering and biocompatibility tests on the physical device, not an AI model tested on a dataset of patient cases. The tests were performed by a "third-party test facility."

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

• Not Applicable. Ground truth, in the context of clinical data interpretation by experts, is not relevant to the physical device tests described here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. This pertains to clinical data interpretation, which is not described.

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

• Not Applicable. This document is for a physical medical device (compression sleeve), not an AI/ML diagnostic or assistive tool.

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

• Not Applicable. This device is a physical sleeve, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the tests performed would be established engineering standards and material science specifications. For biocompatibility, it's the biological response to the materials. For functional tests, it's the physical performance measured against design specifications and predicate device performance.

8. The sample size for the training set

• Not Applicable. This device uses no training data in the AI/ML sense.

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

• Not Applicable. This device uses no training data in the AI/ML sense.

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