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PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material.

The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.

PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below:

• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal),
• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL),
• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Hook and Loop Closure (Universal, XL),
• PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL),
• PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)

PRIMAGARD AAMI PB70:2012 Level 3 gowns are non-sterile, single use isolation gowns intended to be worn by healthcare professionals in isolations. These gowns are made of SMS non woven material, contain ultrasonic seams, provide full coverage (level 3 as per PB70) and are not made with natural rubber latex. The proposed isolation gowns come in 5 different models as described in the Indications for Use.

This document describes the premarket notification for the PRIMAGARD Isolation Gown (AAMI PB70 Level 3). It does not describe an AI/ML powered medical device. Therefore, it is impossible to extract the requested information regarding acceptance criteria and studies related to AI/ML device performance.

The document focuses on demonstrating the substantial equivalence of the PRIMAGARD Isolation Gown to predicate devices based on a comprehensive set of non-AI related performance, safety, and physical property tests.

Here's an overview of the information that is available related to the device's performance based on the provided text, adapted to the requested table format where applicable, but acknowledging that it doesn't fit the AI/ML context:

1. A table of acceptance criteria and the reported device performance (for the non-AI device):

The following information is not applicable or available as the device is not an AI/ML product:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) for an AI/ML device:
Not applicable. The document refers to testing according to various ASTM, AAMI, AATCC, ISO, and 16 CFR standards for physical, chemical, and biological properties of the gown material, not patient data for an AI algorithm. The sample sizes for these material tests are not specified in the provided text, and data provenance in terms of "country of origin of data" or "retrospective/prospective" is not relevant for materials testing in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth in the context of expert consensus is not relevant here as there is no AI/ML model being evaluated against expert opinions on medical images or diagnoses. The "ground truth" for this device is established by the specified performance standards (e.g., AATCC 127 for hydrostatic pressure).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies involving expert review of data where discrepancies need resolution. This is not pertinent to the material and barrier performance testing described.

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 a medical device (isolation gown), not an AI system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product (isolation gown), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the physical device, the "ground truth" is defined by the acceptance criteria specified in recognized industry standards (e.g., AAMI PB70, ASTM standards for material properties, ISO standards for biocompatibility). The device's performance is measured against these established, objective metrics, not against subjective expert consensus or pathology data.

8. The sample size for the training set:
Not applicable. There is no AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established:
Not applicable. As there is no AI/ML model, there is no training set or a process for establishing its ground truth.

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