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To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room peronnel from the transfer of microorganisms, body fluids, and particulate material.

To be used as a protective patient covering, such as to isolate the site of suraical incision from microbial and other contamination.

To be used as an accessory to other surgical drapes; wiping, blotting, hand drying, etc.

Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable

I apologize, but the provided text from the FDA 510(k) notification for the "Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack Reusable" does not contain information about acceptance criteria or a study proving device performance as requested.

The document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in accompanying technical documentation or study reports, which are not part of this specific FDA letter.

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