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The BeneHold™ Surgical Incise Drape with CHG antimicrobial II is indicated for use as an incise drape with continuous antimicrobial activity (in vitro) from 30 minutes through 4 hours of use against the following organisms: S. aureus, S. epidermidis, E. coli, P. aeruginosa, E. aerogenes, and C. albicans. In vitro testing on the subject drape has also shown continuous antimicrobial activity from 30 minutes through 2.5 hours against E. faecalis and F. oxysporum. It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a surgical incise drape. It outlines the regulatory clearance of the device, its intended use, and relevant FDA regulations.

This document does not contain any information about acceptance criteria for a study proving the device meets acceptance criteria, nor does it detail any specific study design, sample sizes, expert involvement, or adjudication methods. The letter focuses solely on the regulatory approval process for the medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The information required (e.g., performance metrics, test set details, ground truth establishment) is not present in this regulatory clearance document.

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