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The Medline Orbis Surgical Gown is a single use, Level 4 surgical gown intended to be worn by healthcare professionals during surgical procedures to help protect both the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.

The Medline Orbis Surgical Gown meets the Level 4 requirements in accordance with ANSI/AAMIPB70:2012 "Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities".

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I am sorry, but based on the provided document, I cannot answer the question as it pertains to the acceptance criteria and study proving a device meets these criteria. The document is an FDA clearance letter for a "Medline Orbis Surgical Gown" and primarily discusses regulatory classifications, general controls, and compliance requirements. It does not contain information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance (country, retrospective/prospective).
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set or how its ground truth was established.

The document only states that the surgical gown "meets the Level 4 requirements in accordance with ANSI/AAMIPB70:2012 'Liquid barrier and performance classification of protective apparel and drapes intended for use in healthcare facilities'." This indicates a standard was met, but it does not detail the specific acceptance criteria within that standard or the study results that demonstrate compliance.

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