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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile 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 5250-06e1.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets those criteria:

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 the exact sample size used for the test set for each characteristic. It broadly states that the device "meets" the requirements, implying testing was performed to the standards. The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer's testing, specifically Suzhou Shengyuda Plastic Products Co.,Ltd. The studies were nonclinical.

3. 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 this device (patient examination gloves) does not involve human interpretation or subjective assessment by experts. The ground truth is established by objective physical and chemical testing against established industry standards and regulations.

4. Adjudication method for the test set

This information is not applicable as there is no subjective assessment or multiple interpretations requiring adjudication. Performance is determined by objective measurements against defined pass/fail criteria in the 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

This information is not applicable. The device is a medical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI are irrelevant.

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

This information is not applicable. The device is a medical glove, not an algorithm or AI system.

7. The type of ground truth used

The ground truth used for this device's performance assessment is based on established industry standards and regulations. These include:

• ASTM standard D 5250-06 e1 (for dimensions and physical properties)
• 21 CFR 800.20 (for freedom from pinholes)
• ASTM D6124-06 (for powder amount)
• AAMI / ANSI / ISO 10993-10:2002 (for biocompatibility regarding primary skin irritation and dermal sensitization)

These standards define objective and measurable criteria for product performance.

8. The sample size for the training set

This information is not applicable. The device is a physical product (medical gloves), not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

This information is not applicable for the same reason as point 8.

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