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Isolation Gown, Model 4005 and 4022, is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not in the operating room. In addition, the Isolation Gown, Model 4005 and 4022 meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gown, Model 4005 and 4022, is a single use, disposable medical device provided non-sterile.

Protective Gown, Model 4021, is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. The Protective Gown, Model 4021, is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.

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The provided text is related to the FDA clearance of "Isolation Gown" and "Protective Gown" products. It is a 510(k) premarket notification letter, which establishes substantial equivalence to a predicate device. This type of clearance does not involve a study to prove a device meets acceptance criteria in the way a medical AI/software device would.

Instead, for these types of physical medical devices (gowns), the "acceptance criteria" are typically defined by recognized standards related to their physical properties and barrier performance. The "study that proves the device meets the acceptance criteria" would be laboratory testing against those standards.

Based on the provided text, here's what can be extracted and interpreted in the context of an AI/software device's performance study:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical gown and not an AI/software device, the "acceptance criteria" are material and performance standards, not typical AI metrics like sensitivity, specificity, or AUC.

For the Protective Gown, Model 4021, no specific AAMI level is claimed in the "Indications for Use" section provided.

Regarding the Absence of AI/Software Device Specific Information:

The rest of the requested information (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, training ground truth) is not applicable to this S10(k) clearance document for physical gowns. These are metrics specifically used for evaluating and clearing AI and software as a medical device (SaMD) products, which are fundamentally different from the personal protective equipment described here.

This document serves as an FDA clearance letter confirming substantial equivalence to a legally marketed predicate device, primarily based on the device's intended use and compliance with relevant performance standards (like AAMI PB70 for the isolation gown). It does not contain details about clinical studies or AI algorithm performance validation.

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