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Powdered 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

The provided text describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI/ML medical device. Therefore, many of the requested categories (such as AI-specific study details, sample sizes for training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this document.

The document outlines the acceptance criteria and the "device performance" in terms of meeting established standards for patient examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of an AI/ML algorithm. The performance evaluation is based on meeting industry standards and regulations for medical gloves. The tests for these characteristics are typically performed on representative samples from manufacturing batches. The document does not provide details on the sample sizes for these tests or their provenance (country of origin, retrospective/prospective).

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

Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or measurements. For a medical glove, "ground truth" is established by adherence to physical, chemical, and biological performance standards defined by regulatory bodies and consensus organizations (e.g., ASTM, FDA). There is no mention of experts establishing a "ground truth" for a test set in the way it would be done for an AI/ML diagnostic device.

4. Adjudication method for the test set

Not applicable. There is no "test set" requiring adjudication in the context of an AI/ML algorithm. The evaluations are direct measurements against predefined standards.

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 an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the device's performance is based on established industry standards and regulatory requirements. Specifically, these include:

• ASTM standard D 5250-00e4 (for dimension, physical properties, powder amount)
• 21 CFR 800.20 (for freedom from pinholes)
• ISO 10993-10 (for biocompatibility, specifically primary skin irritation and dermal sensitization)

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set."

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

Not applicable. This is not an AI/ML device.

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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 5250-00ed

Here's a breakdown of the acceptance criteria and study information for the Zibo Hongye Shangqin Plastic & Rubber Co., Ltd. Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored), based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

This device is a Class I medical device (patient examination glove), and the submission primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device (FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, K032908). Clinical data was explicitly stated as not needed for this type of device.

Here's a breakdown of the study information based on the provided text:

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

   • The document does not specify the exact sample sizes used for the non-clinical tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility).
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective. Given that the manufacturer is based in China, it's highly probable the testing was conducted there, directly by or on behalf of the manufacturer, and would be considered prospective for the purpose of this submission.

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

   • This information is not applicable as the "ground truth" for these performance criteria is established through objective laboratory testing against established material standards (ASTM, CFR). It does not involve expert interpretation or consensus in the typical sense of a clinical diagnostic study.

3. Adjudication method for the test set:

   • Not applicable. As the "ground truth" is based on objective laboratory testing against material standards, there is no need for expert adjudication.

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a patient examination glove and does not involve AI or human interpretation of medical images/data in a diagnostic context.

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

   • No, a standalone algorithm performance study was not done. This device is a physical medical product (glove), not an algorithm or software.

6. The type of ground truth used:

   • The "ground truth" (or reference standard) is based on established industry standards and regulations:
     • ASTM standard D 5250-00e4 (for Dimension, Physical Properties, Powder Residual)
     • 21 CFR 800.20 (for Freedom from pinholes/waterleak test AQL)
     • ISO10993-10 (for Biocompatibility, specifically Primary Skin Irritation and Dermal Sensitization)
     • ASTM D6124-01 (also related to powder residual or other physical properties)

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

8. 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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