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The GMD Circumcision Clamp is intended to be used in the medical procedure of circumferential excision of the foreskin or prepuce skin at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

The GMD Circumcision Clamp is a stainless steel reusable medical device intended to be used in circumcision procedures. The GMD Circumcision clamp will be sold non-Sterile.

The provided 510(k) summary for the GMD Universal Circumcision Clamp does not contain information about acceptance criteria or a study proving the device meets them.

Instead, the document states:

"The company did not conduct, nor depend on, clinical studies or non-clinical laboratory studies in order to establish substantial equivalence as this type of technology and procedure has a long history of clinical use."

This indicates that the device's substantial equivalence was established based on its similarity to a legally marketed predicate device (GOMCO Circumcision Clamp - K894201) and the long history of clinical use of this type of technology, rather than through performance-based acceptance criteria and a specific study.

Therefore, the requested tables and details regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as they are not present.

In summary, none of the specific information requested regarding acceptance criteria and performance studies is available in the provided text. The 510(k) submission relied on substantial equivalence to a predicate device and existing clinical history rather than new performance data.

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