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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Glove, Yellow Color

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves a medical device meets specific acceptance criteria.

The document is an FDA 510(k) clearance letter for a "Disposable Powder Free Vinyl Exam Glove, Yellow Color". It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations that apply. It also includes an "Indications for Use Statement".

However, it does not contain any of the following information requested:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on a standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document pertains to the regulatory clearance of a basic medical glove, which typically does not involve the kind of performance studies or detailed acceptance criteria described in your request, often associated with software or more complex diagnostic/therapeutic devices.

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

The provided text is for a 510(k) summary for Disposable Powder Free Vinyl Exam Gloves. This type of device does not typically undergo studies with the kind of acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone performance assessments that are relevant to AI/ML medical devices or complex diagnostic tools.

The "studies" described in this document are primarily non-clinical tests to ensure the physical properties and safety of the gloves meet established standards for medical devices.

Therefore, many of the requested categories (2-6, 8-9) are not applicable to this submission as they pertain to clinical or diagnostic performance, which is not evaluated for examination gloves in this manner.

Here's an interpretation based on the available information:

Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powder Free

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of samples is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) for the given batch size. Provenance is not specified, but the testing was done for the manufacturer (Xuzhou Full Sun Medical Products Ltd.) in China. This is retrospective testing of manufactured batches.
• Watertight Test: AQL 2.5, Inspection level I. The exact number of samples is not explicitly stated. Provenance is not specified, but the testing was done for the manufacturer. This is retrospective testing.
• Primary Skin Irritation and Skin Sensitization: Sample sizes for these biocompatibility tests are not disclosed but would follow standard biological test protocols. Provenance or specific subjects are not mentioned.

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

N/A. For physical and biocompatibility testing of medical gloves, ground truth is established by standardized test methods and laboratory analysis, not by human expert consensus or interpretation in the way it is for diagnostic imaging.

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

N/A. This concept is not applicable to the non-clinical testing of examination gloves. Test results are objective measurements against a standard.

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

N/A. This device is an examination glove; it does not involve AI, human readers, or diagnostic interpretation.

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

N/A. This device is an examination glove; it is not an algorithm and does not have standalone performance in the context of AI.

7. The type of ground truth used

For physical and dimensions testing, watertight testing, and residual powder testing, the "ground truth" is defined by the numerical specifications and limits set by the applicable ASTM and FDA standards (e.g., ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06). For primary skin irritation and skin sensitization, the "ground truth" is established by biocompatibility test guidelines that determine the absence of adverse biological reactions.

8. The sample size for the training set

N/A. This device does not involve a "training set" in the context of machine learning or complex model development. The manufacturing process of gloves is subject to quality control, but not a "training set" in this sense.

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

N/A. See point 8.

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

Here's the breakdown of the acceptance criteria and study information based on the provided text, focused on the aspects typically used to describe medical device performance studies:

Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Exam Glove Yellow Color

This 510(k) summary primarily addresses the substantial equivalence of a disposable medical glove to a predicate device, focusing on material and physical integrity rather than a complex AI or diagnostic performance study. As such, the typical metrics for diagnostic device performance (e.g., sensitivity, specificity, AUC) are not applicable. Instead, the acceptance criteria relate to compliance with established ASTM standards and FDA requirements for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides specific sample sizes and inspection levels for certain tests:

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Exact numerical sample size not specified, but refers to a standard sampling plan).
• Watertight Test: AQL 2.5, Inspection level I. (Exact numerical sample size not specified, but refers to a standard sampling plan).
• Skin irritation and Sensitization testing: Sample size not specified.
• Residual Powder Test: Sample size not specified.

The data provenance is the manufacturer, Xuzhou Full Sun Medical Products Ltd., in Jiangsu Province, China. The studies are prospective in the sense that they are performed on the manufactured product to demonstrate compliance.

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

Not applicable. This device is a Class I medical device (patient examination glove), and the compliance is assessed through standardized physical, chemical, and biological tests, not through expert interpretation of medical images or diagnostic data. Therefore, "ground truth" as typically defined for AI or diagnostic devices is not established by a panel of experts. The standards themselves define the "ground truth" for acceptable performance.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements or established biological assays, not subjective assessments requiring adjudication.

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 is not a diagnostic device or an AI-powered system that involves human readers or interpretation.

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

Not applicable. This is not an algorithm or AI device. The tests performed are standalone in the sense that they assess the device's inherent properties.

7. The Type of Ground Truth Used

The "ground truth" is defined by adherence to accepted industry standards and regulatory requirements. This includes:

• ASTM Standard D5250-06: For physical and dimensional properties of vinyl examination gloves.
• ASTM Standard D-5151-06: For pinhole detection in medical gloves (watertight test).
• ASTM Standard D6124-06: For residual powder content.
• Biocompatibility principles: Demonstrated through skin irritation and sensitization tests.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Powder Free Vinyl Exam Glove, Yellow Color:

This document is a 510(k) summary for a medical device (a disposable glove), not a typical AI/ML medical device submission. Therefore, many of the requested categories (like MRMC study, ground truth for training set, number of experts for ground truth, etc.) are not applicable as they relate to advanced diagnostic or AI-driven devices. The focus here is on demonstrating substantial equivalency to a predicate device through established physical performance and biocompatibility standards.

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

¹ The document states the device "meets these requirements" or "conforms fully" or "meets requirements" without providing specific measured values for dimensions, watertight test, biocompatibility, or pinhole requirements in the summary. It refers to data in Section 7 which is not fully elaborated with raw numbers.

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

• Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
• FDA 1000 ml Watertight Test: AQL 2.5, Inspection level I. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
• Primary Skin Sensitization Test: Not specified.
• Residual Powder Test: Not specified.
• Data Provenance: The manufacturing company is Ever Global Enterprise Corporation, based in Dong Nai Province, Vietnam. The tests were likely conducted on gloves produced at this facility. The document doesn't explicitly state if the testing was prospective (done specifically for this submission) or retrospective (using existing factory QA data), but it's implied to be part of the product's quality assurance and validation for this submission.

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 (a glove), not a diagnostic device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.

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

Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method.

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 not an AI-driven or diagnostic device.

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

Not applicable. This device is 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 defined by adherence to established national and international standards for medical examination gloves, specifically:

• ASTM D5250-00E4 (Standard specification for Vinyl Examination Gloves for Medical Application)
• ASTM D-5151-99 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-01 (Standard Test Method for Residual Powder on Medical Gloves)
• FDA's 1000 ml Watertight Test (which cites ASTM D-5151-99)
• Biocompatibility requirements (Primary Skin Sensitization)

These standards define objective measurement criteria rather than requiring subjective human "ground truth" interpretation.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set.

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Ask a specific question about this device