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Circumcision of newborns and older males, defined as circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

The Smart Klarap® is a device composed of two components; a transparent plastic conic tube, and a plastic white clamping mechanism. The device is sold sterile for single use, packaged with a disposable sizing guide in a sterile pouch. The Smart Klamp® is available in multiple sizes, to accommodate newborn to adult patients.

The provided text {0} to {3} does not contain information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or results of comparative effectiveness or standalone studies. The document is a 510(k) summary and approval letter for the Smart Klamp® circumcision clamp, stating that the device is substantially equivalent to predicate devices based on its intended use and technological characteristics. It does not include a detailed study proving the device meets specific acceptance criteria in the way a diagnostic or AI device submission might.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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