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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.

Imprevious Isolation Gown

I’m sorry, but this document does not contain the information you are looking for regarding the acceptance criteria and study details for a device. The provided text is a letter from the FDA concerning a 510(k) premarket notification for an "Imprevious Isolation Gown," stating that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

• The FDA's determination of substantial equivalence.
• Regulatory classifications and requirements (general controls, GMP).
• Information on labeling regulations and compliance.
• The intended use of the device (to protect patients and healthcare personnel from transfer of micro-organisms, body fluids, and particulate material).

There is no information about:

• Specific acceptance criteria tables or reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

This type of information is usually found in a separate study report or a more detailed section of a 510(k) submission, not in the FDA's decision letter.

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