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The Desara One mid-urethral mesh implant is intented for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Desara One introducer is intended for the placement of the Desara One single incision mesh implant.

Desara® One Single Incision Sling System

The provided text is a 510(k) premarket notification clearance letter for a medical device called the "Desara One Single Incision Sling System." This type of document is an approval from the FDA, signifying that the device is substantially equivalent to a predicate device already on the market.

However, the 510(k) clearance letter does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. Such detailed performance studies and their results are typically found in the full 510(k) submission, which is a much more extensive document than the clearance letter itself.

Therefore, I cannot provide the requested information from the given text. The text primarily focuses on:

• The FDA's determination of substantial equivalence.
• The device's trade name and regulation details.
• The indications for use.
• General regulatory requirements for medical devices.

To answer your questions, I would need access to the actual scientific and clinical data submitted for the 510(k) premarket notification, which is not present in this document.

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