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Powder Free Vinyl Patient Examination Gloves, Light Yellow Color 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, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1.

The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Light Yellow Color." This is a Class I medical device, and the study described is a non-clinical assessment against established standards, not a study of an AI-powered device. Therefore, many of the requested fields related to AI, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "training set," and "adjudication method," are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in the context of a typical AI/software study. Instead, it refers to compliance with established standards (ASTM, CFR, ISO) which define their own sampling methods for quality control testing of physical products. The data provenance is implied to be from the manufacturer's own testing procedures to demonstrate compliance with these standards. There is no mention of country of origin of data (beyond the manufacturer's location in China) or whether it was retrospective or prospective in the sense of a medical study.

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

Not applicable. The "ground truth" for this device is compliance with established physical and biological standards, determined through laboratory testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of results 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 an AI device.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

The ground truth used is defined by established regulatory and industry standards for patient examination gloves, including:

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

8. The Sample Size for the Training Set

Not applicable. This is a physical product and not an AI/machine learning device that requires a training set.

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

Not applicable. As above, there is no training set for this type of device.

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