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The AAMI Level 4 Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The AAMI Level 4 Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities; but has an open back which is non-protective.

The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile.

The AAMI Level 4 Protective Gown is a single use, disposable medical device and is provided non-sterile. It has an open back which is non-protective.

This document is a 510(k) clearance letter for an AAMI Level 4 Protective Gown. It is not a study report for a diagnostic device or an AI/software-as-a-medical-device (SaMD) product. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not applicable to this document.

The document states that the device "meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012 - Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities". This indicates the performance standard the device is intended to meet, but it doesn't provide the detailed acceptance criteria or a study write-up in the format requested for a software device.

In summary, the provided text does not contain the information necessary to answer the specific questions about acceptance criteria, study design, and performance metrics as it pertains to a diagnostic or AI device. It is a regulatory clearance for a physical medical device (a protective gown).

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