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Powdered Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes a 510(k) summary for "Powdered Vinyl Patient Examination Gloves, Light Yellow Color." This is a medical device that falls under the category of general hospital devices, specifically patient examination gloves.

The text does not describe an AI/ML powered device, nor does it involve any studies related to human readers, AI assistance, or complex diagnostic tasks. The "acceptance criteria" and "study" described in the document are for basic physical, chemical, and biological properties of the gloves, not for an AI algorithm.

Therefore, I cannot extract the information required for the requested table and parameters related to an AI/ML device. The document pertains to a much simpler Class I medical device.

Here's a breakdown of why this document doesn't fit the request and what information can be extracted:

• No AI/ML Component: The device is a physical product (gloves), not a software or AI-driven system.
• No "Ground Truth" for AI: Concepts like expert consensus, pathology, or outcomes data as "ground truth" are irrelevant for examination gloves.
• No "Readers" or "Adjudication": There are no human readers or AI algorithms being evaluated in a diagnostic context.
• No "Sample Size for Test/Training Set" in AI Sense: The phrase "sample size" in this document refers to the quantity of gloves tested for physical properties (e.g., freedom from pinholes), not data points for an AI model.
• No "Effect Size of Human Readers Improve with AI": This is completely unrelated to the device described.

What can be extracted related to "acceptance criteria" from the provided text for this specific device:

The "acceptance criteria" are essentially the relevant ASTM standards and FDA regulations that the gloves must meet. The "device performance" is stated as "Meets" for all these criteria.

Table of Acceptance Criteria and Reported Device Performance (as per the document):

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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text is a 510(k) summary for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Based on the content provided, the device in question is a medical glove, not an AI/ML-driven medical device. Therefore, the questions related to AI/ML device performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, and effect sizes of human reader improvement with AI assistance) are not applicable to this document. The provided text does not contain information about an AI/ML device or its performance study.

However, I can extract the acceptance criteria and reported device performance from the provided text for the medical glove.

Acceptance Criteria and Reported Device Performance (for Medical Glove):

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

This document describes the acceptance criteria and study for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

1. Table of Acceptance Criteria and Reported Device Performance:

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Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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 Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Light Yellow Color." This is a Class I medical device, and the study described is a non-clinical assessment against established standards, not a study of an AI-powered device. Therefore, many of the requested fields related to AI, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "adjudication method," are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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