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Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

The provided text describes the acceptance criteria and study for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The testing is described as meeting established standards (ASTM, FDA regulations, ISO).
The data provenance is not explicitly mentioned as retrospective or prospective, nor are specific countries of origin for the data provided beyond the manufacturer's location in China. The testing is non-clinical, primarily relying on performance against established industry standards.

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 device and its testing. The "ground truth" for these types of medical gloves is established by their adherence to defined physical, chemical, and biological performance standards, not by expert consensus in diagnostic interpretation. The standards themselves are developed by expert bodies.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For physical product testing against objective standards, the results are either pass or fail based on the standard's criteria.

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 is not applicable. This device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI are irrelevant.

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

This is not applicable. This device is a physical product (a glove), not a software algorithm.

7. The type of ground truth used:

The ground truth is established by industrial and regulatory standards.

• Physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual): The ground truth is defined by the objective pass/fail criteria outlined in ASTM D 5250-06, ASTM D6124-06, and 21 CFR 800.20. These are quantifiable measurements and thresholds.
• Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The ground truth is established by the results of biological tests on animal models, as per ISO10993-10, demonstrating the absence of harmful irritant or sensitizing reactions.

8. The sample size for the training set:

This is not applicable. This device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of its development or evaluation.

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

This is not applicable as there is no training set for this device.

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