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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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The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes.

It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "BeneHold™ Surgical Drape with CHG". This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of a performance study (e.g., for an AI/ML powered device).

Instead, this document confirms that the device is substantially equivalent to a legally marketed predicate device and outline general regulatory requirements. It does not include performance data, expert qualifications, sample sizes for test/training sets, or details about comparative effectiveness studies.

The "Indications for Use" section mentions "continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes." This refers to laboratory testing of the antimicrobial properties of the drape, not a clinical study involving human patients or a performance study for an AI-powered device.

Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device