Search Results

GRI's Non Reinforced, Film Reinforced, and Fabric Reinforced Surgical Gowns are sterile or non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

GRI's Non Reinforced, Film Reinforced and Fabric Reinforced Surgical Gowns are made from SMS fabrics and polypropylene/polyethylene protective reinforcement to provide user protection in surgical settings. The gowns are available in various designs and combinations of materials, sizes, and reinforcement configurations.

The Non Reinforced Surgical Gowns meet the requirements of AAMI Level 2 liquid barrier requirements.

The Fabric-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

The Film-Reinforced Surgical Gowns meet the requirements of AAMI Level 3 liquid barrier requirements.

This document describes the validation of GRI Surgical Gowns for their liquid barrier properties and other physical characteristics, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document details that the GRI Surgical Gowns met acceptance criteria for various bench tests. While explicit numerical acceptance criteria are not provided, the performance is described in relation to AAMI liquid barrier levels and general physical properties.

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

The document does not explicitly state the sample sizes used for each specific test. However, it indicates that "performance testing" was conducted. The data provenance is not specified, but the device manufacturer, GRI Medical & Electronic Technology Co., Ltd., is located in ZheJiang, China, suggesting the testing might have been conducted in China or by a certified testing facility accredited to international standards. The study is a retrospective submission for regulatory clearance (510(k)), meaning the testing was completed prior to the submission date.

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

This information is not applicable to this testing. The "ground truth" for surgical gowns, in this context, is established by adherence to recognized national/international standards (like AAMI for liquid barrier properties) and standard test methods for physical properties. There is no involvement of human experts for "ground truth" establishment in the way it would be for a diagnostic AI device assessing medical images. The performance is objectively measured against physical/chemical standards.

4. Adjudication Method for the Test Set:

This information is not applicable. The testing involves objective physical measurements and comparisons against established technical standards (e.g., AAMI levels). There is no "adjudication" in the sense of resolving disagreements among human observers for image interpretation.

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:

This information is not applicable. The device under review is a surgical gown, a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant.

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

This information is not applicable. As a surgical gown, the device does not involve an algorithm or AI. Its performance is entirely standalone in terms of its physical properties and barrier function without human-in-the-loop interaction in a diagnostic or interpretive sense.

7. The Type of Ground Truth Used:

The "ground truth" for the device's acceptable performance is based on:

• Established Standards: Adherence to AAMI (Association for the Advancement of Medical Instrumentation) liquid barrier classifications (Level 2 and Level 3).
• Bench Testing Protocols: Standardized laboratory tests for physical properties such as biocompatibility, hydrostatic pressure, impact penetration, resistance to blood penetration, "fly around" (linting), tensile strength, tear strength, and seam strength. These tests have defined methodologies and criteria for pass/fail.

8. The Sample Size for the Training Set:

This information is not applicable. Since the device is a physical product and not an AI/machine learning model, there is no "training set."

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

This information is not applicable as there is no training set for this type of medical device.

Ask a specific question about this device