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The Caremed Supply Inc. VESOFLOW®PLUS SQS and IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

VESOFLOW®PLUS that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). VESOFLOW® PLUS is a non-invasive mechanical prophylactic system that massages the feet or legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as antiembolic stockings and anticoagulants.

VESOFLOW®PLUS is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, VESOFLOW®PLUS is identified as a compressible limb sleeve.

The provided text is a 510(k) premarket notification for a medical device (VESOFLOW®PLUS DVT Compression Devices). It outlines the device's purpose, non-clinical testing, and a comparison to a predicate device to claim substantial equivalence.

However, the document does not describe a study involving an AI/Machine Learning device that requires a test set, training set, or human expert adjudication. The device in question is a mechanical deep vein thrombosis (DVT) compression device, and the evaluation focuses on standard medical device safety and performance testing (biocompatibility, software, electromagnetic compatibility, electrical safety, performance, and risk management) as well as substantial equivalence to a previously marketed device.

Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, including sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, cannot be extracted from the given text.

The document explicitly states in "5.9 Clinical Testing": "No clinical test data was used to support the decision of safety and effectiveness." This further confirms that there was no study of the type you are asking about for this particular device submission.

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