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Trinity's Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel necessary for the performance of the circumcision surgical procedure..

Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel.

This document is a 510(k) premarket notification letter from the FDA regarding a "Circumcision Tray." It does not contain information about acceptance criteria or a study proving device performance as requested. The document primarily discusses the substantial equivalence determination for the device and clarifies regulatory aspects, including an issue with a drug component (PVP Swabsticks) included in the tray.

Therefore, I cannot provide the requested information based solely on the provided text. The requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) would typically be found in the 510(k) submission itself, not in the FDA's decision letter.

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