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Intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

USA Gloves Nitrile Gloves and aforementioned predicate device are Non-powdered patient examination glove, as defined in 21 CFR 880.6250. Former Release Powder or Chemical: No release powder or chemical is used. USA Gloves Nitrile Gloves is not intended to be sterilized. The device is delivered in packaging which may be used as a protective carrying case.

The document provided is a 510(k) Premarket Notification from the FDA for USA Gloves Nitrile Powder Free Exam Gloves (K211624). This type of document is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy through clinical studies with "AI" components or human readers improving with AI assistance. As such, many of the requested categories (2-9) are not applicable or cannot be extracted from this specific type of regulatory submission.

Here's the information that can be extracted and a clear indication where the requested information is not applicable:

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

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 specify the sample sizes used for each test. The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond the fact that these are nonclinical tests conducted to standard methodologies.

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 a medical glove, and "ground truth" in the context of expert review for image analysis or diagnostic performance is not relevant. The testing involves standardized laboratory methods for physical and biocompatibility properties.

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

Not applicable. Adjudication methods are typically used in clinical studies or expert reviews. The tests performed are objective, standardized laboratory measurements.

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 device is a medical glove, not an AI-powered diagnostic tool. There were no MRMC studies or AI involvement mentioned.

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

Not applicable. This device is a medical glove, not an algorithm or AI system.

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

The "ground truth" for the nonclinical tests is established by the specified international standards (ASTM and ISO). For example, physical properties are compared against defined thresholds (e.g., tensile strength min 14 Mpa), and biocompatibility tests look for the absence of specific biological responses (e.g., no cytotoxicity, no skin irritation). These are objective, measurable criteria defined by the standards.

8. The sample size for the training set

Not applicable. This document describes the testing of a manufactured physical device (medical glove), not the development of an algorithm or AI model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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