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INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION

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The provided text is a 510(k) premarket notification approval letter for "Sterile Operating Room Towels, Blue" (K981823) from the FDA to Baldur Systems Corporation. This document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic devices.

The information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are characteristic of the data typically provided in submissions for AI/ML-powered medical devices or diagnostic devices that require performance evaluation studies.

Since the device in question is "Sterile Operating Room Towels," a low-risk product, the FDA approval is based on substantial equivalence to a predicate device rather than on detailed performance metrics from a clinical study as would be required for more complex devices or AI/ML technologies.

Therefore, I cannot provide the requested information based on the input document. The document simply states the intended use as: "XXE INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION" (intended to be used for covering an incision site during surgery from microbial contamination).

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