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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

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)

I am sorry, but the provided text is a Food and Drug Administration (FDA) clearance letter for a medical device, specifically "Polymer Coated, Powder-Free Latex Examination Gloves with Protein Labeling."

This document does not contain the information required to answer your request about acceptance criteria and a study proving device performance.

The letter focuses on:

• Confirming that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device.
• Outlining regulatory requirements and general controls provisions.
• Providing contact information for further guidance.
• Stating the intended use of the gloves.

There is no mention of:

• Specific acceptance criteria for performance.
• Any study data, sample sizes, data provenance.
• Expert involvement for ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot generate the requested table or answer the specific questions based on the provided input.

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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.

Polymer-Coated , Powder-free , Latex Patient Examination Glove

This is a 510(k) approval letter from the FDA for a "Polymer Coated, Powder-Free Latex Examination Glove." This document is a regulatory approval and does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/CADe device.

Therefore, I cannot extract the requested information from this document.

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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.

Powder-Free Latex Examination Gloves Polymer Coated with Protein Content Labeling Claim (100 Micrograms or Less)

This document is a 510(k) premarket notification approval letter from the FDA for "Powder-Free Latex Examination Gloves Polymer Trade Name: Coated with Protein Content Labeling Claim (100 Micrograms or Less)."

It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance, but does not include any performance data, study designs, or ground truth information relevant to the original request.

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