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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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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "SE-100 Vacuum Erection Device."
This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. These details would typically be found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the given text.

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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.

SE-300 Vacuum Therapy System

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter for a medical device (SE-300 Vacuum Therapy System) and an "Indications for Use" statement. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, this document does not contain any information about acceptance criteria, study details, device performance data (beyond its intended use), sample sizes, ground truth establishment, or expert qualifications that would be necessary to fulfill your request. The letter is purely an administrative clearance, not a clinical study report.

Ask a specific question about this device