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Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.

Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel backed by a polyester hook and loop fabric.

The provided 510(k) summary for the Implantech Associates Inc. "Gelzone" device does not contain a study that proves the device meets specific acceptance criteria in the manner of a performance study. This is a premarket notification where substantial equivalence to a predicate device is claimed, not a study demonstrating efficacy against defined metrics.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) cannot be extracted from this document as no such study is presented.

The summary states:

"Efficacy
Gelzone's silicone layer is manufactured with silicone gel. This silicone layer is the same material used in the current Implantech Gel Sheeting and Conform Sheeting products. The manufacturer of the gel has an FDA Master File which includes information on their formulation, on manufacturing methods, testing, and toxicology information."

This indicates that the efficacy is primarily supported by the known properties of the silicone gel material and its prior use in substantially equivalent devices, rather than a new clinical study with specific acceptance criteria for the Gelzone product itself.

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