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The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.

The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed.

The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.

The provided text is a 510(k) summary for the "wee BELL Circumcision Device" and describes its characteristics, intended use, and comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving performance against such criteria for a medical device that would involve a test set, ground truth, expert opinions, or MRMC studies.

The document states:

• "Nonclinical functional performance testing was performed on the subject device and included functional testing (visual inspection, tensile testing and smoothness testing), packaging testing per ASTM F88-21, ASTM D4169-22 and ISO 11607, sterilization per ISO 11135:2014 and biocompatibility according to ISO 10993-1 for a surface device in prolonged contact with intact skin. Additionally, material mediated pyrogenicity was conducted."

This indicates engineering and material-based tests were performed to ensure the device's physical properties, sterility, and biocompatibility, but not clinical performance benchmarks in terms of diagnostic accuracy or effectiveness measured against a ground truth developed by experts. The device is a "manual instrument," not an AI/ML-driven diagnostic device, which is typically what the questions (sample size for test set, ground truth, experts, MRMC, etc.) pertain to.

Therefore, I cannot provide the requested table and information based on the provided text, as the type of evaluation described is foundational for a medical device's physical integrity and safety, rather than a clinical performance study with statistical endpoints related to diagnostic accuracy or efficacy improvement with human-in-the-loop.

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