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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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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 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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A Powder Free Vinyl Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Vinyl Examination Gloves

I regret that I cannot fulfill your request to describe the acceptance criteria and study for a medical device based on the provided text. The document you've shared is an FDA 510(k) clearance letter for "Powder Free Vinyl Examination Glove" (K122377).

This type of document primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device. It does not typically contain the detailed information about acceptance criteria, the specific studies performed to prove the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment that you've requested.

The FDA 510(k) clearance process for Class I devices like examination gloves often relies on demonstrating equivalence to existing devices rather than requiring extensive de novo clinical trials with detailed performance metrics and statistical analyses as might be seen for higher-risk devices or novel technologies.

Therefore, the information necessary to answer your specific questions (e.g., a table of acceptance criteria and performance, sample sizes for test/training sets, details on expert ground truth, MRMC studies, standalone performance) is not available within these pages.

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Powder free 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.

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

This is a summary of the acceptance criteria and study information for the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)".

1. Table of Acceptance Criteria and Reported Device Performance

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A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.

Powder-Free Vinyl Examination Glove

The provided document, Premarket Notification 510(k) K071022 for a Powder-Free Vinyl Examination Glove, does not contain any information regarding AI/ML device performance or studies involving human readers, training sets, or ground truth as typically associated with AI-powered medical devices.

Instead, this submission is for a medical glove, and the acceptance criteria and supporting studies are based on traditional physical and biocompatibility testing according to established ASTM and ISO standards.

Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission. I will answer the applicable questions based on the provided text, and explicitly state when a category is not relevant.

Acceptance Criteria and Device Performance

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "The performance test data that support a determination of substantial equivalence are described above in Section 7" (which is the section outlining standards and specifications). However, it does not explicitly state the sample sizes used for the physical or biocompatibility testing, nor does it specify the data provenance (country of origin, retrospective/prospective). The testing would typically be prospective, conducted by the manufacturer (Glormed Colombia S.A.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical product (medical glove). Ground truth in the context of expert review (e.g., for image interpretation) is not relevant here. Performance is measured against physical and chemical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See explanation for #3. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic tasks, which is not relevant for glove testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical glove, not an AI software. No MRMC study or AI assistance is involved.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by conformance to internationally recognized industry standards such as ASTM D 5250-00, ASTM D 5151-99, ASTM D 6124-00, and ISO 10993. These standards define the acceptable physical properties, non-toxicity, and integrity of medical examination gloves. There is no biological "ground truth" from patients or pathology in the sense of AI diagnostics.

8. The sample size for the training set

Not applicable. This device is a medical glove and does not involve AI/ML requiring a training set.

9. How the ground truth for the training set was established

Not applicable. See explanation for #8.

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A patient examination Vinyl Powder Free Gloves is a disposable device Intended for medical patient and examiner. A patient examination vinyl in the is worn on the examiner' device Intended for medical patient and examiner.

Powder Free Vinyl Examination Glove

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powder Free Vinyl Examination Glove" and an "Indications for Use" statement.

This document does not contain information about the acceptance criteria and study results for an AI/device's performance as typically requested for medical AI devices. It details the FDA's decision regarding substantial equivalence for a medical glove, which is a physical device, not a software or AI-driven diagnostic tool.

Therefore, I cannot extract the requested information such as test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment, as this information is not present in the provided text.

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A patient examination Vinyl Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Vinyl Powder Free Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Vinyl Powder Free Examination Gloves." It primarily concerns regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies of the device itself. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria is not present here.

Based on the provided text, I can answer some of the questions, but many will be marked as "Not Applicable" or "Information Not Provided" because this type of regulatory correspondence does not contain such details.

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

This information is Not Provided in the document. The letter states the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the same performance standards, but it does not specify those standards or the Great Glove (China) Incorporated's device's performance against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is Not Provided. The document does not describe any specific test set or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is Not Applicable as no test set or ground truth establishment is described for a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is Not Applicable as no test set or adjudication process is described for a performance study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is Not Applicable. This device is a Vinyl Powder Free Examination Glove, which is a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is Not Applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is Not Applicable as no specific performance study or ground truth establishment is described. The "ground truth" for regulatory approval in this context is the safety and effectiveness profile of the predicate device.

8. The sample size for the training set

This information is Not Applicable as this is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This information is Not Applicable as this is a physical medical device, not a machine learning model requiring a training set and associated ground truth establishment.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

This request cannot be fulfilled as the provided text is a 510(k) clearance letter for patient examination gloves. This type of document declares substantial equivalence to a predicate device and does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the AI/ML device context described in the request. The letter is a regulatory compliance document for a physical medical device (gloves), not an AI/ML algorithm.

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A patient examination glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Examination Gloves

The provided document is a 510(k) premarket notification letter from the FDA to a manufacturer of disposable powder-free vinyl examination gloves. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria, device performance studies, or ground truth establishment for an AI/device. It is a regulatory approval letter for a simple medical device (gloves) and does not involve AI or complex performance metrics beyond basic safety and effectiveness for its intended use (preventing contamination).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.

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