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GRI single use drapes (both sterile and non-sterile) are made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Non-sterile GRI surgical drapes are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

GRI single use surgical equipment covers (both sterile and non-sterile) are protective barrier covers intended to be used to cover surgical equipment and provide a protective barrier for that equipment.

Non-sterile GRI surgical equipment covers are sold, in bulk as single use items, to repackager/relabeler establishments for further packaging and ethylene oxide (EtO) sterilization.

Device Description

GRI's single use drapes and surgical equipment covers with AAMI Liquid Barrier Level 3 claim are constructed with various base sheet fabric and reinforcement fabric types, provided in various sizes and shapes, and may contain fluid collection pouches or clear film panels as components. The base sheet fabric is a three layer laminate comprised of polypropylene spunbond/polypropylene mettblown/polypropylene spunbond. Layers are thermally embossed together producing a single layer with various basis weights. Fabric is topically treated to enhance water repellency and to assure static dissipation. The drape reinforcement fabrics are constructed of various configurations of spunbond, meltblown and film. The reinforcement materials are spunbond/film laminate. The primary component of these materials is polypropylene with surfactant and blue pigment.

AI/ML Overview

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study for the GRI Sterile and Non-Sterile Surgical Drapes and Surgical Equipment Covers:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Material Properties:
Biocompatibility:	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Cytotoxicity: Met acceptance criteria
Primary Skin Irritation: Met acceptance criteria
Sensitization: Met acceptance criteria
Hydrostatic Pressure	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Impact Penetration	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Tear Strength	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Tensile Strength	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Linting	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Flammability	Not explicitly stated, but "met acceptance criteria" and "substantially equivalent to predicate devices" implies compliance with relevant standards.	Met acceptance criteria
Liquid Barrier:	AAMI Standard PB70 Liquid Barrier Level 3	Classified as Level 3 per AAMI Standard PB70

Note: The document states that "All tests results met acceptance criteria and were substantially equivalent to the predicate devices." While the specific numerical acceptance criteria for each test are not detailed in this summary, the general statement indicates successful compliance.

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

The document does not specify the exact sample sizes used for the performance testing.
The origin of the data is not explicitly mentioned as a country, but GRI Medical & Electronic Technology Co., Ltd. is located in ZheJiang, China. This suggests the testing may have been conducted there or by a contracted lab. The study is retrospective in the sense that it relies on laboratory testing of the device rather than a clinical trial.

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

This information is not applicable to this type of device and study. The "ground truth" for surgical drapes and equipment covers relates to objective performance criteria (e.g., barrier properties, strength, biocompatibility), which are measured in laboratory settings against established standards, not through expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like "2+1" are typically used in studies involving human interpretation (e.g., image analysis by radiologists) to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, especially with and without AI assistance. This document describes the performance testing of physical barriers (surgical drapes and equipment covers).

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 product (surgical drapes and equipment covers), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The device itself is "standalone" in that its physical properties are tested.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective performance standards and test methods. Specifically, the document mentions compliance with:

AAMI Standard PB70 for liquid barrier performance.
Other unnamed standards for biocompatibility (cytotoxicity, primary skin irritation, sensitization), hydrostatic pressure, impact penetration, tear strength, tensile strength, linting, and flammability.

8. The Sample Size for the Training Set:

This information is not applicable. This is not a machine learning or AI-driven device, so 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 device.

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