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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 5250-00-4.

The provided text describes a submission for a medical device, specifically "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)," rather than a complex AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to studies of diagnostic accuracy, which are not performed for basic medical devices like gloves.

Here's an analysis based on the provided text for the aspects that are applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document for each test. The standards referenced (e.g., ASTM D5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10) specify sampling plans for testing, but the exact number of gloves tested for this specific submission is not provided.
• Data Provenance: Not explicitly stated. The testing was conducted by the manufacturer, JIANGSU JAYSUN GLOVE CO., LTD, which is based in China. The data would therefore be internal testing results generated by the manufacturer. It is prospective testing, as it's performed to demonstrate compliance of the manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. This device is a physical product (gloves), and performance is assessed against engineering standards and biocompatibility tests, not by expert interpretation or diagnosis for which "ground truth" established by human experts would be relevant.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study requiring adjudication of expert opinions.

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-powered diagnostic device.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the referenced International and National Standards (e.g., ASTM D 5250-00e4 for physical properties, 21 CFR 800.20 for freedom from pinholes, ASTM D6124-01 for powder residual, and ISO10993-10 for biocompatibility).

8. The sample size for the training set:

Not applicable. This device does not involve machine learning algorithms that require a "training set."

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

Not applicable. This device does not involve machine learning algorithms.

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