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A 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.

On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)

The provided text is a 510(k) premarket notification approval letter for a medical device: "On-line Powder-free Latex Patient Examination Gloves, Type II, Low Modulus with Extractable Protein Content Labeling Claim (50 Micrograms per gram or less)".

This document is a regulatory approval and does not describe a study to prove the device meets acceptance criteria in the way envisioned by the request. The request asks for details about a study to evaluate "device performance" in terms of metrics like accuracy, effect size with AI assistance, and ground truth establishment, which are typical for diagnostic or AI-powered devices.

For a patient examination glove, the "acceptance criteria" and "study" would refer to manufacturing standards, chemical composition, biocompatibility, physical properties (e.g., tensile strength, elongation), and extractable protein content. The approval letter confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it meets the same safety and effectiveness standards.

Therefore, I cannot fulfill the request as formatted because the provided document does not contain the information required to populate the requested table and answer the study-specific questions. There is no information on:

1. A table of acceptance criteria and reported device performance in the context of an accuracy study.
2. Sample sizes for test sets, data provenance, or retrospective/prospective nature.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory confirmation of substantial equivalence for a physical medical product, not a clinical or performance study report for a diagnostic or AI device.

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