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Disposable Vinyl Examination Gloves 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.

The subject device is a patient examination glove made of Poly (vinyl chloride) compound. It is Non-Sterile, Powder free and is clear in colour. The device is ambidextrous and can be worn on either the left or right hand. (Per 21 CFR 880.6250, class I). The device provides four specifications: S, M, L and XL. The device meets all the specifications in ASTM D5250-19, Standard specification for Vinyl Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-10, ISO 10993-23, ISO 10993-5

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Disposable Vinyl Examination Gloves":

This document is a 510(k) summary for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device. As such, it describes performance testing rather than a study proving the device meets acceptance criteria in the context of clinical AI performance. The device in question is a physical product (gloves), not an AI/software device.

Therefore, many of the requested points, especially those related to AI device performance, sample sizes for test/training sets, ground truth, experts, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided tables for the physical aspects of the gloves.

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance

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The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.

The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.

Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical examination gloves:

1. Table of Acceptance Criteria and Reported Device Performance

• Width (Small): 85±5mm
• Width (Medium): 95±5mm
• Width (Large): 105±5mm
• Width (Extra-Large): 115±5mm
• Thickness (Finger): ≥ 0.08mm
• Thickness (Palm): ≥ 0.08mm | Pass |
  | ASTM D5250 (Physical Properties - Before Aging) | To determine tensile strength and ultimate elongation before aging | - Tensile Strength: ≥ 11MPa
• Ultimate Elongation: ≥ 300% | Pass |
  | ASTM D5250 (Physical Properties - After Aging) | To determine tensile strength and ultimate elongation after aging | - Tensile Strength: ≥ 11MPa
• Ultimate Elongation: ≥ 300% | Pass |
  | ASTM D5151 | Freedom from pinholes | Meets the ASTM D5151 Test for AQL 2.5 requirements | Pass |
  | ASTM D6124 | Powder Residue | Meets ASTM D6124 requirements:

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A non-powdered 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.

A Disposable Powder Free Vinyl Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). The operation principle of this medical device is to provide single use barrier protection for the wearer and the device meets all the requirement specifications for barrier protection, tensile properties as defined in ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.

The document provides information about the non-clinical performance evaluation of "Disposable Powder Free Vinyl Examination Gloves, Beige/Clear" to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

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

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The Disposable Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free non-colored vinyl examination glove. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves a "Disposable Vinyl Examination Glove" meets these criteria. It is important to note that this is a Class I medical device (non-AI/ML).

Here's the breakdown of the requested information:

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

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The DISPOSABLE VINYL EXAMINATION GLOVE (Pink, Black, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination glove. The subject device's color is pink, black and blue. It can be available in four specifications: S, M, L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Disposable Vinyl Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device based on bench testing (non-clinical testing) rather than clinical studies involving human patients or complex AI algorithms.

Therefore, many of the requested points related to AI, MRMC studies, expert ground truth adjudication, and clinical trial specifics are not applicable to this submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.

The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.

Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:

1. Table of Acceptance Criteria and the Reported Device Performance

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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for Vinyl Examination Gloves. This is a medical device focused on physical properties and biocompatibility, not an AI/imaging device. Therefore, many of the requested criteria regarding AI model evaluation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment methods) are not applicable to this document.

However, I can extract the relevant information regarding the device's performance against its acceptance criteria based on the provided non-clinical testing summary.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors are disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors

This document is a 510(k) clearance letter for "Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors" from Shen Wei USA Inc. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification for Vinyl Examination Gloves, not an AI/ML medical device. Therefore, the information requested in the prompt regarding AI/ML device acceptance criteria and study details (such as sample sizes for test and training sets, expert ground truth, multi-reader multi-case studies, etc.) is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of the Vinyl Examination Gloves to a predicate device through non-clinical performance testing.

Here's a breakdown of the non-clinical acceptance criteria and reported performance, as directly extractable from the provided text, adapted to the table format requested:

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

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The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.

The powder free vinyl patient examination glove is a clear, non-colored, disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is sold as non sterile.

The provided text is an FDA 510(k) clearance letter for a medical device: "Powder Free Vinyl Patient Examination Glove." This document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria for a diagnostic algorithm or AI-powered medical device.

The letter explicitly states:

• Device Name: Powder Free Vinyl Patient Examination Glove
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: Class I, reserved
• Product Code: LYZ

This is a physical, disposable medical glove, not a diagnostic algorithm or an AI system. The 510(k) clearance for such a device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, typically through performance standards for physical properties, biocompatibility, and manufacturing processes, rather than the type of clinical study outlined in your request (e.g., MRMC, standalone algorithm performance, ground truth establishment for AI/diagnostic devices).

Therefore, I cannot fulfill your request using the provided text because it describes a completely different type of medical device and does not include the information you've asked for regarding acceptance criteria and performance studies for an AI or diagnostic algorithm.

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