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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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 5250-06e1.

The provided text describes the acceptance criteria and performance of a medical device, specifically Powder Free Vinyl Patient Examination Gloves. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It simply states that the device "meets" the specified standards for various characteristics.

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

The provided text does not mention using experts to establish ground truth for a test set. This type of device (patient examination gloves) typically relies on standardized laboratory testing rather than expert-based evaluation for its performance characteristics.

4. Adjudication method for the test set:

The provided text does not describe any adjudication method for a test set. Adjudication is not applicable in this context as performance is assessed against objective technical 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:

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This is a medical glove, not an AI-powered diagnostic or imaging tool that would involve human readers. Therefore, there is no mention of such a study or an effect size for AI assistance.

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

A standalone algorithm performance study is not applicable to this device. This product is a physical medical device (gloves) and does not involve any algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for evaluating this device's performance is based on objective technical standards and laboratory testing specified by ASTM and FDA regulations. For example:

• Dimensional and Physical Properties: Defined by ASTM standard D 5250-06 e1.
• Freedom from pinholes: Defined by 21 CFR 800.20.
• Powder Residual: Defined by ASTM standard D 5250-06 e1 and D6124-06.
• Biocompatibility: Defined by ISO 10993-10 for primary skin irritation and dermal sensitization.

8. The sample size for the training set:

The provided text does not mention a "training set" as this is not a machine learning or AI-driven device. Performance is evaluated against established physical and chemical standards.

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

The concept of a "training set" and its ground truth establishment does not apply to this device as it is not an AI/ML product. The "ground truth" for the device's characteristics is defined by the accepted industry and regulatory standards.

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