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Spectrum Designs Spectragel is indicated for use in the topical mangement of hypertrophic and keloid scars. Spectrum Designs Spectragel may also be used prophylactically to help retard the formation of such scars.

Spectragel is used only on intact skin and is manufactured out of medical grade, biocompatible silicone material.

The provided text is a summary of a 510(k) submission for a medical device called "Spectragel Silicone Gel." It describes the device, its indications for use, and the FDA's "substantially equivalent" determination to pre-amendment devices.

However, this document does not contain any information about a study that assesses the device's performance against acceptance criteria. The acceptance criteria and the study details you've requested are typically found in clinical trial reports or performance validation studies, which are not included in this particular FDA communication.

Therefore, I cannot provide the detailed information about acceptance criteria or a study from the given text. The document is primarily an FDA clearance letter based on substantial equivalence, not a detailed performance study report.

In summary, the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets them.

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