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Surgical Drapes are single use and shall be used by medical professionals in an operating room or healthcare setting for patient protective covering.

Various Sterile and Non-Sterile Surgical Drapes, DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET AND POLY-U-DRAPE

This document is a 510(k) clearance letter from the FDA for various sterile and non-sterile surgical drapes. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria or reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• A standalone algorithm performance study.
• The type of ground truth used.
• The sample size or ground truth establishment for a training set.

This document is solely an FDA clearance stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It does not elaborate on the specific performance studies that might have been conducted by the manufacturer to support their submission.

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