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Erco-Ribbon™ is used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump or naturally).

Erco-Ribbon can be used for patients with following conditions:

a) separately:

premature ejaculation

firm but short lasting erection

b) as a part of a vacuum constriction system

Diabetes

Venous leakage

Prostatectomy

Hypertension

Psychogenic condition

Radiation therapy

Spinal cord injury

A constriction ribbon is made of elastic and soft silicone with generally rectangular cross section. A belt with release loop is used for keeping the constrictor in a prearranged tightened position and for unlocking the ribbon.

The material conforms FDA regulation for devices contacting human skin.

For unlocking of the constrictor. the belt's release loop is pulled forward. The belt slips off, allowing easy unwrapping of the constricting ribbon.

A mounting tube comprises a segment of acrylic tube.

For arrangement of Erco-Ribbon™ penile constriction device, the ribbon is wrapped with the tension by multyple turns over the segment of the proximal end of the mounting tube. (or a vacuum chamber, when Erco-Ribbon ™ is used as a part of a vacuum constriction system),

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the ERCO-RIBBON™ constriction device, primarily focusing on establishing substantial equivalence to previously marketed predicate devices.

Therefore, I cannot provide the requested information in the table or answer the other questions as the data is not present in the given text.

The document describes:

• The intended use of the Erco-Ribbon™.
• A brief description of the device's design and materials.
• A comparison of the Erco-Ribbon™ to predicate constriction rings, highlighting perceived advantages in terms of ease of use and pressure control.
• The FDA's decision of substantial equivalence.

There is no mention of:

• Specific acceptance criteria for performance metrics (e.g., pressure range, material durability, comfort levels).
• Any studies (clinical or benchtop) conducted to demonstrate the device's performance against such criteria.
• Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or details about training and ground truth for any potential studies.

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