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The Securline Operating Room Drape is a drape accessory made of synthetic material intended to be used as a protective patient covering such as to isolate a site of surgical incision from microbial and other contamination.

The Securline Operating Room Camera Drape, Model #3600 is a drape accessory made of synthetic material.

The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device, the 'Securline Operating Room Camera Drape, Model #3600'. This document is a regulatory approval letter, not a scientific study report.

Therefore, the input you provided does not contain the information needed to describe acceptance criteria and a study that proves a device meets those criteria. Specifically, it lacks:

• Acceptance criteria: There are no performance metrics or thresholds defined for the device.
• Reported device performance: No data on how the device performed against any criteria is present.
• Study details: There is no mention of a clinical trial, performance study, or any other type of study. Consequently, information such as sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details are entirely absent.

This letter simply states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain the detailed study information you requested for an AI/device performance evaluation.

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