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When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients. The compression garments are prescription devices intended for a single patient use only.

Compressible limb sleeves are devices that are used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb and increasing venous flow. Compression therapy is generally prescribed as a prophylaxis for deep vein thrombosis (DVT). The compression system consists of two primary pieces: an air compression pump and a soft, flexible sleeve in which the patient's extremity is placed. A hose to the pump connects to the sleeve, and when the pump is turned on, the air inflates the sleeve, applying a gentle pressure to the patient's extremity. Compression garments consist of a non-woven fabric with "hook and loop" fasteners for attaching around the leg. Air cells within the garment are molded to plastic hoses with connectors for attachment to the pump. The hoses and connectors are non-detachable and are reprocessed as part of the garment. Vanguard Reprocessed Compression Garments (Hill-Rom) contain multiple compartments and hoses that are sequentially pressurized. Vanguard receives previously used compression garments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the garments; and returns them to a healthcare facility.

The provided text is a 510(k) summary for the Vanguard Reprocessed Compression Garments (Hill-Rom). This document describes a medical device and its substantial equivalence to predicate devices, focusing on reprocessing. It does not contain information about a study that establishes acceptance criteria for AI/ML device performance or involves human readers, experts, or ground truth establishment relevant to AI/ML device evaluation.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.

The document discusses:

• Cleaning, packaging, and sterilization validations: These demonstrate that the reprocessed devices perform as intended and are safe and effective.
• Performance and biocompatibility testing: These also support the safety and effectiveness of the reprocessed devices.
• Sterilization validation: This specifically demonstrates that sterility is achieved to a 10^-6 assurance level using ethylene oxide gas.

These are related to the physical reprocessing of the garments and ensuring they meet the same specifications and safety profiles as new, non-sterile garments. They are not related to an AI/ML device's diagnostic or predictive performance.

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