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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.

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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