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The ERECXEL Adjustable Penile Bands are indicated as over-the-counter treatment for men with erection problem due to penile venous leakage. During erection, the ERECXEL Adjustable Penile Bands device helps to produce penile rigidity by constricting the penile veins around the base of the penis to restrict the flow of blood from leaving the penis.

ERECXEL Adjustable Penile Band is an external penile constriction device that is comprised of a split ring made of latex-free, bio-compatible rubberplastic. It is designed with fastening parts, consisting of interlocking teeth and cavities carried on each end of the ring. This simple mechanism permits the user to easily adjust the diameter of the device, allowing him to set its size to provide him the optimum degree of penile constriction that the device will effect during use. The device is designed with a urethral groove to allow the normal ejaculation process to occur during its use. It is also provided with tabs on each fastening end to facilitate its quick release from the penile shaft and is available in different sizes to accommodate the wide variation of penile sizes among men.

This K993343 submission for the ERECXEL Adjustable Penile Bands does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance study results with specific acceptance criteria. The FDA's letter (K993343 - Page 2 of 2) confirms the device's substantial equivalence based on the provided information, but this does not imply a formal performance study was conducted or presented in this particular submission.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies, as this information is not present in the provided text.

The document primarily describes the device, its intended use, and compares its technological design to a predicate device to argue for substantial equivalence. It highlights differences in the fastening/adjustment mechanism as an improvement in efficacy, safety, and comfort, but it does not present empirical data to support these claims through a formal study with acceptance criteria.

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