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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4

The provided document refers to the 510(k) summary for "FUGUAN (Brand) Powder Free Vinyl Patient Examination Gloves". This is a medical device application for gloves, not a complex AI-powered diagnostic or therapeutic device. As such, the study design and acceptance criteria are focused on physical and biological properties of the gloves, rather than diagnostic performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or human-AI interaction in a clinical setting.

Therefore, the requested information categories typically applicable to AI/ML device studies (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not relevant to this specific product.

Here's a breakdown of the acceptance criteria and performance as described in the document, tailored to the nature of this device:

Acceptance Criteria and Device Performance for FUGUAN Powder Free Vinyl Patient Examination Gloves

Study Details:

• Sample size used for the test set and the data provenance: The document does not specify a distinct "test set" in the context of an AI/ML study. The evaluation appears to be based on quality control testing of representative samples of the manufactured gloves for each characteristic. No specific sample sizes for these tests are provided in this summary. Data provenance is implied by the manufacturer's location (Shijiazhuang Fuguan Plastic Products Co., Ltd., China) and adherence to international standards (e.g., ASTM, ISO) and US regulations (e.g., 21 CFR). The testing is generally prospective, as it involves evaluating manufactured products against predetermined standards.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these types of devices is established by objective measurements against recognized industry standards (e.g., ASTM for physical properties, 21 CFR for pinholes, ISO for biocompatibility). Human expert consensus is not a factor for these objective measures.
• Adjudication method for the test set: Not applicable. The "ground truth" is determined by direct measurement and adherence to established pass/fail criteria from the standards.
• 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 patient examination glove, not an AI-powered diagnostic tool requiring human reader studies.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical product, not an algorithm.
• The type of ground truth used:
  • Objective Standards: The "ground truth" is established by publicly available and internationally recognized technical standards and regulations:
    • ASTM standard D 5250-00e4 (for dimensions, physical properties, powder residual)
    • 21 CFR 800.20 (for freedom from pinholes/waterleak test)
    • ASTM D6124-01 (implied for powder residual measurement)
    • ISO10993-10 (for biocompatibility, specifically irritation and sensitization)
• The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/ML device. Manufacturing processes are optimized through engineering and quality control, not machine learning training.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study demonstrating the device meets the acceptance criteria is a series of non-clinical bench tests and biocompatibility assessments. These tests are performed on samples of the manufactured gloves to ensure they conform to established safety and performance standards. The conclusions are drawn from these non-clinical tests, affirming that the FUGUAN (Brand) Powder Free Vinyl Patient Examination Gloves meet the requirements of ASTM standard D 5250-00e4, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10. This substantiates that the device is as safe and effective as the predicate device (Shijiazhuang Great Eagle Plastics Products Co., Ltd. K000071). Clinical data was deemed not necessary for this type of device.

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