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Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.

The Halyard Tri-Layer AAMI 3 Isolation Gown ("Isolation Gown") is a single use gown, supplied non-sterile. The gowns come in the following sizes: Large, X-Large. These surgical gowns are apparel that are intended to be worn by healthcare professionals to protect from varying levels of fluid contact (low to moderate). These surgical gowns meet the AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, Level 3 Requirements. These Isolation Gowns are manufactured from three-layer full length polypropylene SMS material, with neck tape, elastic cuffs, and waist belt closure systems.

The provided document details the non-clinical testing performed on the Halyard Tri-Layer AAMI 3 Isolation Gowns to demonstrate their substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The sample sizes for the test sets are indicated for each test in the acceptance criteria table. For example, for Spray Impact (AATCC 42) and Hydrostatic Pressure (AATCC 127), the sample size is n=35 with c=3. For Static Decay (STM-00180), the sample size is n=36 with c=0. For Grab Strength and Tear Strength (ASTM D5034, D5733, D1683), the sample size is n=24 for a one-sided 95/95 tolerance limit. For Flammability (CFR 1610), the sample size is n=49 with c=0. For Lint Generation (EN ISO 9073-10), the sample size is n=30.

The document does not specify the country of origin of the data or whether the data is retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is a submission for an isolation gown, and the testing involves laboratory measurements against established physical and material standards, not expert clinical evaluation for a diagnostic or AI device.

4. Adjudication Method for the Test Set:

Not applicable. The tests are laboratory-based and measure physical properties against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-enabled device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI-enabled device.

7. The Type of Ground Truth Used:

The "ground truth" for the performance of the isolation gowns is based on established industry and international standards for protective apparel (e.g., AAMI PB70:2012, AATCC, ASTM, ISO standards). The device's physical and material properties are directly measured and compared against the predefined acceptance criteria within these standards.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set as this is not an AI/machine learning algorithm.

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