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A patient examination glove is a disposable device intended for medical purposes that is I x partient examiner's hand or finger to prevent contamination between patient and examiner.

Pre-Powdered, Non-Sterile, Vinyl Exam Gloves, Yellow

The provided text is a 510(k) premarket notification letter from the FDA regarding "Pre-Powdered, Non-Sterile, Vinyl Exam Gloves, Yellow." This document indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain information about:

• Acceptance criteria and reported device performance beyond regulatory substantial equivalence.
• Any specific study (like a clinical trial or performance study) proving the device meets performance-based acceptance criteria. The 510(k) process primarily assesses substantial equivalence to a predicate device, which usually involves comparing design, materials, chemical composition, energy source, manufacturing process, and intended use, and often does not require new clinical efficacy or performance studies if the device is similar enough to a legally marketed one.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. These are typically associated with performance studies for more complex or novel medical devices, especially those involving AI/ML.

The device in question, patient examination gloves, is a Class I medical device, which generally has lower regulatory hurdles and typically does not require extensive performance studies as described in the prompt's request. The substantial equivalence determination is based on the device's similarity to existing gloves already on the market.

Therefore, based solely on the provided text, I cannot populate the requested table and answer the study-specific questions. The document confirms regulatory clearance but does not detail the type of performance data or studies that would involve the metrics requested.

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