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Elta Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Elta Wound Cleanser." It states that the device is substantially equivalent to legally marketed predicate devices. The document also includes the "Indications for Use" for the device.

However, the text does not contain any information about:

• Acceptance criteria or reported device performance
• Details of any study (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set) that would prove the device meets acceptance criteria.

The letter is a regulatory approval document and not a scientific study report. Therefore, I cannot fulfill your request for the specific details of a study and acceptance criteria based solely on the provided text.

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