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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, 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

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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:

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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

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 is a 510(k) Premarket Notification summary for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the provided information, framed by your questions:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is for a medical device (patient examination gloves) that is subject to performance standards rather than requiring complex algorithmic analysis or human reader studies. Therefore, most of your requested points regarding AI/algorithm performance, ground truth establishment, and expert involvement are not applicable to this type of device and submission.

The "acceptance criteria" here refer to the performance requirements outlined in recognized standards (like ASTM and FDA regulations) for patient examination gloves. The "study" proving the device meets these criteria refers to non-clinical testing performed by the manufacturer.

1. A table of acceptance criteria and the 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 5250-00-4

The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI/ML medical device. Therefore, many of the requested categories (such as AI-specific study details, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this document.

The document outlines the acceptance criteria and the "device performance" in terms of meeting established standards for patient examination gloves.

1. Table of Acceptance Criteria and 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 5250-0084.

1. Acceptance Criteria and 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 5250-004

Here's a breakdown of the acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided text:

1. Table of Acceptance Criteria and 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 5250-00ed

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

The document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device