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The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.

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The provided document is a 510(k) clearance letter from the FDA for the POS-T-VAC (AVP-1000) Vacuum Erection Device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device, and does not require clinical studies in all cases, especially for well-established device types like vacuum erection devices.

Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory clearance, not detailed performance studies or their associated acceptance criteria.

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