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Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.

The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

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

The document describes the PT. MAHAKARYA INTI BUANA Polymer Examination Gloves, Powder Free, Non Sterile. The provided information focuses on non-clinical performance data and does not include details on clinical studies or AI-driven aspects.

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 sample sizes used for testing each characteristic. It also does not explicitly state the country of origin of the data for these tests, nor whether they were retrospective or prospective. Given the nature of a 510(k) submission for examination gloves, these would typically be conducted by the manufacturer in a controlled laboratory setting (prospective testing) following the specified ASTM and FDA standards.

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. The measurements and assessments for these physical and chemical characteristics of gloves are determined by standardized test methods (e.g., ASTM standards) and laboratory procedures, not by expert interpretation or ground truth established by medical experts in the way that imaging or diagnostic AI would require.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically relevant for subjective assessments or when there's disagreement among human readers/experts, which is not the case for the objective physical, chemical, and biological tests described.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This product is a physical device (examination gloves), not an AI-driven diagnostic or assistive tool. Therefore, studies comparing human reader performance with and without AI assistance are not relevant and were not conducted.

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

This is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.

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

The "ground truth" for these tests is defined by the objective criteria and methodologies outlined in the referenced ASTM and FDA standards (e.g., specific measurement techniques for dimensions, visual inspection criteria for pinholes, chemical assays for protein content, and animal testing protocols for biocompatibility). There is no "expert consensus" or "pathology" involved in establishing the ground truth for glove performance tests in the context of this submission.

8. The sample size for the training set

This is not applicable. The product is a physical device, and the testing described is not related to machine learning or AI, which would require a training set.

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

This is not applicable, as there is no training set for a machine learning model.

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