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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 fingers to prevent contamination between patient and examiner.

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

This document is a 510(k) Summary for Synthetic Vinyl Examination Gloves, a Class I medical device. It details the device's characteristics and its equivalence to a predicate device, supported by non-clinical testing.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Physical Dimensions (ASTM D5250): The sample sizes are implied by the ranges provided for width and thickness (e.g., "XS: 78-79/ Pass" suggests testing across multiple samples within each size). No explicit total sample size or country of origin for the data is provided, but the manufacturer is based in China. The testing is non-clinical.
• Watertightness Test for Detection of Holes (ASTM D5151): 125 leaks were tested from a sample size that is not explicitly stated. The method is "0/125 leaks / Pass", suggesting 125 units were tested (or 125 opportunities for leaks in a larger sample).
• Powder Content (ASTM D6124): "Medium glove is the representative sample of the product." The exact number of medium gloves tested is not specified.
• Physical Properties (ASTM D412): "Medium glove is the representative sample of the product." The exact number of medium gloves tested is not specified.
• Biocompatibility (ISO 10993-5, ISO 10993-10): The studies were conducted on the subject device. No explicit sample size for these biological tests is provided, nor the country of origin of the data.

All data provenance is implied to be from non-clinical laboratory testing performed by or for Yunnan Huazhiyuan Medical Technology Co., Ltd. in China, as indicated by the submitter's information. All studies are retrospective in the sense that they are evaluations of a fully developed product.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document describes non-clinical performance and biocompatibility testing for a medical glove. No human-derived ground truth or expert consensus was used to establish the "ground truth" for the test set. The acceptance criteria are based on established international standards (ASTM and ISO).

4. Adjudication Method for the Test Set

There was no adjudication method as this involved quantitative laboratory testing against pre-defined scientific standards rather than subjective human assessment requiring consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. This is a non-clinical submission for a Class I general hospital device (examination gloves). Such studies are not applicable or required for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is a physical medical glove, not an algorithm or AI-driven system. The testing is standalone in the sense that the device's performance was evaluated intrinsically against standards, without human intervention affecting its core function during testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on established international standards and specifications:

• ASTM D5250: Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
• ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
• ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves.
• ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (implied basis for physical properties).
• ISO 10993-5: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
• ISO 10993-10: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As no training set was used, no ground truth needed to be established for it.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided document is a 510(k) Premarket Notification from the FDA for "Synthetic Vinyl Examination Gloves." This type of document is for medical devices that are deemed substantially equivalent to a predicate device, and thus, typically does not involve the rigorous clinical studies that would require extensive details on acceptance criteria and study methodologies as one might find for a novel device or software.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K153028) by comparing performance against recognized ASTM and ISO standards for examination gloves. Therefore, the questions related to AI performance, reader studies, ground truth establishment, and training sets are not applicable to this device.

Here's an analysis of the available information regarding acceptance criteria and testing, tailored to the context of a medical glove:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Synthetic Vinyl Examination Gloves" are based on recognized industry standards for medical gloves, primarily ASTM D5250, ASTM D5151, and ASTM D6124, along with biocompatibility standards ISO 10993-5 and ISO 10993-10. The device's reported performance demonstrates compliance with these standards.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample sizes used for each of the non-clinical tests (e.g., number of gloves tested for tensile strength, holes, etc.). The tests refer to compliance with ASTM and ISO standards, which typically define their own sampling plans.
   • Data Provenance: The tests were conducted by the manufacturer, Jiangsu Huayuan Medical Technology Co., Ltd. The document does not explicitly state the country of origin of the data beyond the manufacturer's location in China. The testing appears to be prospective for the subject device to demonstrate compliance with the stated standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For non-clinical tests of physical properties and biocompatibility of medical gloves, "ground truth" is established by laboratory measurement against predefined objective criteria in the standards, not by expert consensus or subjective assessment.

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

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic interpretations, especially in image analysis where human readers evaluate cases. For objective laboratory testing, results are determined by instrumentation and adherence to standard protocols.

4. 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 or a device that involves human reader interpretation in a diagnostic context.

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

   • Not Applicable. This device is a physical medical glove and does not involve any algorithms or AI for standalone performance.

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

   • For the physical and performance tests, the "ground truth" is defined by the objective, quantitative specifications outlined in the referenced national and international standards (ASTM D5250, ASTM D5151, ASTM D6124).
   • For biocompatibility tests, the "ground truth" is established by the biological response observed in standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests as per ISO 10993-5 and ISO 10993-10, evaluated against predefined criteria for an acceptable biological reaction.

7. The sample size for the training set:

   • Not Applicable. This device is a medical glove. It does not involve a "training set" in the context of machine learning or AI.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set, this question is not relevant.

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A Synthetic Vinyl Examination Gloves, Powder-free, Yellow 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.

Synthetic Vinyl Examination Gloves, Powder-free, Yellow

This document is a 510(k) premarket notification decision letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free, Yellow". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. It is a regulatory approval letter, not a performance study report.

Therefore, I cannot provide the requested information:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Synthetic Vinyl Examination Glove, Powder Free 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.

Synthetic Vinyl Examination Gloves, Powder-Free

This document is a 510(k) clearance letter from the FDA for "Synthetic Vinyl Examination Gloves, Powder-Free". It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device.

The document is a regulatory approval for a medical device (gloves) based on substantial equivalence to a predicate device, not on performance studies against specific acceptance criteria like those used for AI/ML algorithms.

Therefore, I cannot provide the requested information. This document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, nor data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Ground truth establishment for a training set.

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A Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent device in between patient and examiner.

Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)

The provided text is a 510(k) premarket notification letter from the FDA regarding "Synthetic Vinyl Examination Gloves, Powder Free (Blue/Green)". This document primarily deals with regulatory approval based on "substantial equivalence" to a legally marketed predicate device.

It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.

Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria and performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training). The document is a regulatory approval letter, not a scientific study report.

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Synthetic Vinyl Examination Glove, Powder Free 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.

Synthetic Vinyl Examination Gloves, Powder-Free

I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "Synthetic Vinyl Examination Gloves, Powder-Free." It primarily discusses the regulatory classification of the device and general compliance requirements.

This document does not contain any information about:

• Acceptance criteria for device performance
• A study proving the device meets acceptance criteria
• Sample sizes for test or training sets
• Data provenance
• Ground truth establishment or type
• Number or qualifications of experts
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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Synthetic Vinyl examination glove, Powder Free 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, Synthetic Vinyl Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder-Free, Synthetic Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/software as a medical device (SaMD).

Instead, it's a regulatory approval document for a Class I medical device (patient examination glove). The "acceptance criteria" discussed in this document refer to regulatory compliance and the demonstration of substantial equivalence to an already legally marketed predicate device, rather than performance metrics from a technical study for a diagnostic or therapeutic device.

Therefore, I cannot extract the requested information (1-9) as it pertains to AI/SaMD performance studies from this document.

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