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ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown 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.

The ProTEC-USA EZDoff Gown is constructed of 41 gsm blue polyolefin (Polyethylene) film offered in one universal size. The body of the gown is provided with belt ties that are constructed of the same 41 gsm blue polyolefin (Polyethylene) film. The sleeves of the gown are sealed using a heat-sealing method.

The document describes the acceptance criteria and study results for the ProTEC-USA EZDoff Gown, a non-sterile, single-use protective medical gown.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • For Hydrostatic Pressure and Water Impact tests, "three (3) nonconsecutive lots" were utilized.
  • For Breaking Strength and Tearing Strength tests, "three (3) nonconsecutive lots" were utilized.
  • For Linting, "three (3) nonconsecutive lots" were utilized.
  • The specific number of units tested within each lot is not provided.
  • For Flammability, Cytotoxicity, Sensitization, and Irritation, a specific sample size is not explicitly stated beyond "Under the conditions of the studies."
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These were non-clinical, lab-based tests.

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

This information is not applicable as the document describes non-clinical testing of a medical gown. The "ground truth" here refers to objective measurements against established international and national standards, not expert medical opinion.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests were objective measurements against predefined standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance:

This information is not applicable. The device is a protective medical gown, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. The device is a physical medical gown, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the performance evaluation of the ProTEC-USA EZDoff Gown was established through objective measurements against established international and national standards (e.g., AAMI PB70:2012, CPSC 16 CFR Part 1610, ASTM D5034, ASTM D5587, ISO 9073-10, ASTM C522, ISO 10993-5, ISO 10993-10). These standards define the acceptable performance characteristics for medical gowns and materials.

8. The Sample Size for the Training Set:

This information is not applicable as the document describes non-clinical testing of a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable as there was no training set for an algorithm. The "ground truth" for evaluating the gown's performance was derived from the aforementioned standardized test methods.

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