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The Powder Free Blue Nitrile Examination Glove, Non Sterile 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.

The Powder Free Blue Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00a53 and FDA 21 CFR 800.20.

Here's a breakdown of the acceptance criteria and study information for the WRP Asia Pacific Sdn Bhd's Powder Free Blue Nitrile Examination Gloves, Non-Sterile, based on the provided document:

This document is a 510(k) summary for a medical device (examination gloves), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than a comprehensive clinical study report for a novel AI device. Therefore, many of the requested categories for AI/software studies are 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 a distinct "test set" sample size in the context of a software or diagnostic algorithm. The performance evaluation is based on testing batches of manufactured gloves against established ASTM and FDA standards. The provenance of the data is from WRP Asia Pacific Sdn Bhd, located in Sepang, Selangor Darul Ehsan, Malaysia. The testing would be considered prospective for each manufactured batch.

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)

This is not applicable as the study involves physical property testing of manufactured gloves, not expert judgment for ground truth in an AI or diagnostic context. The "ground truth" is defined by objective measurements against established technical standards.

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

Not applicable. This is not a study requiring adjudication of expert interpretations for a test set. Physical property testing follows defined laboratory protocols.

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 or software device. It is a physical medical device (examination gloves).

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

Not applicable. This is not an AI or software device.

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

The ground truth for the performance claims (dimensions, physical properties, pinholes, powder residual, biocompatibility) is based on objective measurements against established industry standards (ASTM D 6319-00aE3, FDA 21 CFR 800.20, ASTM D 6124-01) and standardized biological tests (Primary Skin Irritation in Rabbits, Dermal Sensitization).

8. The sample size for the training set

Not applicable. This is not an AI or software device that undergoes a "training" phase.

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

Not applicable. There is no concept of a "training set" for this device.

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