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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. The device is single use only.

The Pearlescent Black Textured Powder- Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with (Protein Content Labeling Claim) Contains 50 micrograms or less of Total Water Extractable Protein per gram which had been submitted and cleared under 510(k) number K013793. The difference in this submission is: a) Change of color to be Pearlescent Black.

The provided document describes the acceptance criteria and performance of "Pearlescent Black Textured Powder-Free Latex Examination Gloves, Coated with Aloe Vera at pH 5.0-5.5, with Protein Content Labeling Claim". This is a medical device (examination glove) and the testing performed is for product specifications and biocompatibility, not for a diagnostic AI algorithm. Therefore, many of the requested categories (sample size for test/training sets, experts for ground truth, adjudication, MRMC studies, standalone performance, data provenance) are not applicable in this context.

Here's the relevant information that can be extracted:

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 for each test, but the methods are based on ASTM standards (e.g., AQL for pinholes), which involve specific sampling plans. For biocompatibility, "Rabbits" are mentioned for Primary Skin Irritation, implying a biological study with an animal test set.
• Data Provenance: Not explicitly stated, however, the testing is performed to meet US standards (ASTM) for FDA clearance. The document is a 510(k) summary submitted to the FDA in the USA.

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

• Not applicable as this is a device performance test based on laboratory measurements and biological reactions, not expert interpretation of data.

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

• Not applicable. The tests involve quantifiable measurements against established 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 device.

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

• Not applicable. This is not an AI algorithm. The device itself (the glove) is the "standalone" component being tested for its physical, chemical, and biological properties.

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

• The "ground truth" here is defined by objective, measurable criteria established by recognized national and international standards (ASTM). For example, a glove either meets the specified AQL for pinholes or it does not, based on the statistical sampling plan and water leak test. For protein level, it's a quantitative measurement of protein content verified against a threshold. For biocompatibility, it's the observed biological response (or lack thereof) in test subjects.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable.

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