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A patient examination Vinyl Powdered Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powdered Vinyl Examination Glove

I apologize, but the provided text from the FDA 510(k) summary for the "Powdered Vinyl Examination Glove" does not contain the kind of detailed information requested about acceptance criteria and a study proving device performance as typically understood for AI/software-as-medical-device (SaMD) products.

This document is a marketing clearance letter for a physical medical device (gloves), not a software or AI product. The 510(k) process for traditional devices like examination gloves primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through physical performance testing rather than clinical study efficacy for a diagnostic or therapeutic purpose.

Therefore, I cannot extract the requested information. The document does not describe:

1. Acceptance criteria and reported device performance in a table: While there are regulations for gloves (e.g., barrier integrity), specific acceptance criteria and performance data in a detailed table as requested for an AI model are not present.
2. Sample size and data provenance for a test set: This is not relevant for a physical glove's 510(k) submission in the context of an AI study.
3. Number/qualifications of experts for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is for an AI-assisted diagnostic or therapeutic tool.
6. Standalone performance (algorithm only): Not applicable, as this is not an algorithm.
7. Type of ground truth: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document does state the Indications for Use: "A patient examination Vinyl Powdered Gloves is a disposable medical purpose that is worn on the device intended for medical contamination between patient and examiner." This indicates its purpose is as a barrier for medical examinations.

For a medical device like this glove, the "studies" usually involve physical and chemical testing to ensure it meets general controls and performance standards (e.g., tensile strength, resistance to tearing, absence of pinholes, biocompatibility). These details are typically found in the full 510(k) submission, but not in the clearance letter provided.

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