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proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or 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.

proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

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This document is a 510(k) premarket notification approval letter for ProMEDICAL Surgical Drapes and Surgical Equipment Covers. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to a specific performance study (like clinical trial results for an AI/ML device).

Instead, it refers to the general requirements for surgical drapes and equipment covers, implying that the acceptance criteria would be related to material properties, sterility, and barrier function as required by the relevant FDA regulations (21 CFR 878.4370). The "study" here is essentially the manufacturer's demonstration that their device meets these general requirements and is substantially equivalent to existing devices, evidenced by the 510(k) submission.

Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and reported device performance, nor details about sample sizes, experts, adjudication methods, or MRMC studies, as these aspects are not present in the provided text.

The information provided is specific to regulatory approval for a medical device (surgical drapes and equipment covers) based on substantial equivalence, and not a performance study as would be conducted for a diagnostic AI device.

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