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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) are disposable devices which made of PVC material, intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device, organized according to your requested information:

Description of Acceptance Criteria and Proving Study

This submission describes the acceptance criteria and performance for "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)". The device's performance is demonstrated through nonclinical testing against established ASTM standards and FDA regulations, as clinical data is explicitly stated as not being needed for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

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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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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 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document describes the acceptance criteria and the study results for the Hebei Tengda Plastic Co., Ltd. Powdered Vinyl Patient Examination Gloves, Clear (Non-colored).

1. Table of Acceptance Criteria & Reported Device Performance

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and study information for K101664, based on the provided text:

Reported Device: Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)

1. Table of Acceptance Criteria and Reported Device Performance

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Powdered 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.

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

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: Powdered Vinyl Patient Examination Gloves, Clear (non-colored)

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Shijiazhuang Star Plastic Powdered Vinyl Patient Examination Gloves:

Acceptance Criteria and Device Performance

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided information regarding the device's acceptance criteria and the study demonstrating its compliance:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

The provided text describes the acceptance criteria and performance of "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It does not pertain to an AI/ML device or software. Therefore, many of the requested categories in the prompt are not applicable.

Here's the information that can be extracted relevant to the prompt, acknowledging the nature of the device:

1. A table of acceptance criteria and the reported device performance

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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.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device