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The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.

The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large. The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and examiner. The device meets all requirements of ASTM D6319-19.

The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Gloves. This document describes the substantial equivalence of the subject device to a predicate device, primarily through non-clinical testing. It does not describe a study involving an AI/software as a medical device (SaMD) or any comparative effectiveness study with human readers improving with AI assistance.

Therefore, many of the requested points related to AI/SaMD performance, ground truth establishment for AI training/testing, MRMC studies, expert adjudication, and effect sizes are not applicable within the context of this document.

This document focuses on proving the physical and chemical properties of a medical glove meet established ASTM and ISO standards for safety and effectiveness, similar to a legally marketed predicate device.

Here's the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides a comprehensive table outlining the acceptance criteria (standards) and the reported performance of the Powder Free Nitrile Gloves.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., how many gloves were tested for dimensions, tensile strength, pinholes, etc.). It refers to meeting the requirements of standards like ASTM and ISO, which would inherently include specified sample sizes for their respective tests. The provenance of the data is not specified beyond being part of a 510(k) submission from "ST FUTURE INTERNATIONAL LIMITED" (Hong Kong) through a consultant in China. The testing itself is non-clinical/laboratory-based.

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. This is not an AI/SaMD study requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for the device's properties is established by the methods and criteria defined in the referenced ASTM and ISO standards for physical and chemical testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/SaMD study involving human reader interpretation or adjudication.

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/SaMD study.

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

Not applicable. This is not an AI/SaMD study. The "device performance" refers to the intrinsic physical and chemical properties of the glove.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on objective measurements and laboratory testing results against established industry standards (ASTM, ISO and their specific test methods). For example:

• Physical dimensions are measured.
• Tensile strength and elongation are measured using standardized equipment.
• Pinholes are detected via water leakage tests per ASTM D5151-19.
• Residual powder is measured gravimetrically.
• Biocompatibility tests (cytotoxicity, systemic toxicity, irritation, sensitization) are conducted following ISO standards using biological models (in vitro cell cultures, guinea pigs).

8. The sample size for the training set

Not applicable. This is not an AI/SaMD device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/SaMD device.

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