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The SUILE Ointment Wound Dressing is indicated for the management of 1ª and 2ª4 degree burns, partial thickness wounds, donor sites and abrasions.

SUILE Ointment Wound Dressing

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a wound dressing, not a study report or a document detailing the acceptance criteria and performance of a device based on a specific study.

Therefore, I cannot extract the information required to answer your questions as it is not present in the provided text. The document is primarily about regulatory approval and does not contain details regarding:

• Acceptance criteria and reported device performance in a table format.
• Sample size or data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance of an algorithm.
• Type of ground truth used.
• Sample size for a training set.
• Method for establishing ground truth for a training set.

This document confirms that the SUILE Ointment Wound Dressing is "substantially equivalent" to legally marketed predicate devices for the indicated uses, but it does not provide the detailed study results you are asking for.

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The SUILE Wound Dressing is indicated for the management of 1st and 2nd degree burns, partial thickness wounds, donor sites and abrasions.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "SUILE Wound Dressing." It states that the device is substantially equivalent to a legally marketed predicate device.

The request asks for acceptance criteria and a study that proves the device meets those criteria. However, this type of information is not present in the provided FDA 510(k) clearance letter.

Here's why and what kind of information is typically found in such a letter:

• 510(k) letters primarily communicate that a device has been found "substantially equivalent" to a predicate device already on the market. This means the FDA believes the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
• They do not typically contain detailed study results, acceptance criteria, or performance data. Those details are part of the original 510(k) submission that the manufacturer provides to the FDA, but they are generally not summarized or included in the public clearance letter itself. The letter simply confirms the FDA's decision based on its review of that submission.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document only contains the following relevant information:

• Trade/Device Name: SUILE Wound Dressing
• Regulatory Class: Unclassified
• Product Code: FRO
• Indications For Use: The SUILE Wound Dressing is indicated for the management of 1st and 2nd degree burns, partial thickness wounds, donor sites and abrasions.
• Predicate Device: The letter states the device is "substantially equivalent... to legally marketed predicate devices," but it does not name the specific predicate device.

To get the information you're asking for, one would typically need to review the full 510(k) submission, which is often much more extensive than the clearance letter.

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