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DeRoyal Back Table Covers are intended to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field. DeRoyal's Back Table Covers will provide protection against contamination during surgical procedures.

DeRoyal will receive the nonsterile back table covers from a converter made to DeRoyal's specifications. DeRoyal will use them to wrap convenience kits that will be sterilized in a header pouch. When the convenience kit is removed out of the header pouch it will be used as a surgical drape for the surgical operating room back table. DeRoyal will market nonsterile sterilization wrap to other OEM customers.

This document is a 510(k) clearance letter from the FDA for a surgical drape, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the document discusses:

• The FDA's review and determination of substantial equivalence for the DeRoyal Surgical Drapes BackTable Cover to a legally marketed predicate device.
• Regulatory requirements and guidelines for marketing the device.
• The intended use of the device ("to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field" and "provide protection against contamination during surgical procedures").
• Manufacturing and sterilization processes for the device.

There is no mention of acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or details about comparative effectiveness studies for an AI/ML device.

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