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A 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.

Nitrile Exam Gloves, Powder-Free, White

The provided text describes a 510(k) submission for "Nitrile Exam Gloves, Powder-Free, White." The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance criteria through a clinical trial or algorithm-based assessment. Therefore, many of the requested categories for AI/algorithm-driven device studies are not applicable.

Here's an analysis based on the provided text, with explanations for non-applicable criteria:

Acceptance Criteria and Device Performance for Nitrile Exam Gloves, Powder-Free, White

This submission pertains to a medical glove, a Class I device, and therefore the "acceptance criteria" are related to established physical and biocompatibility standards for such devices, rather than performance metrics for an AI algorithm. The "study" refers to a series of tests against these standards.

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 provided text for each test. General reference to "Test Results (Means and/or Results)" suggests samples were tested according to standard protocols for each criterion.
• Data Provenance: Not specified, but implied to be from laboratory testing of the manufactured gloves. The country of origin of the data is not mentioned. It is prospective testing of the device for submission.

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

• Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device requiring expert ground truth for a test set. The "ground truth" is defined by the established ASTM and FDA standards for glove performance.

4. Adjudication method for the test set

• Not Applicable. As per point 3, there's no diagnostic decision or interpretation requiring adjudication. Performance is measured objectively against predefined thresholds in the 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-assisted 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.

7. The type of ground truth used

• Objective Standards: The "ground truth" is defined by the established, published standards and test methods from ASTM and the FDA (e.g., ASTM D 3578-95, ASTM D 5151, FDA Water Leak Test, Bio-Compatibility tests assessing specific biological reactions). These standards set the minimum acceptable performance metrics for the glove.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML algorithm that requires a training set. The manufacturing process of the gloves is designed to meet the standards, not "trained" on data.

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

• Not Applicable. As per point 8.

Summary Notes:

The provided document is a 510(k) summary for a relatively low-risk medical device (Class I), focusing on demonstrating substantial equivalence to a legally marketed predicate device. The "proof" that the device meets acceptance criteria comes from laboratory testing against established governmental and industry standards for its physical and biocompatibility properties. The framework for AI/ML device evaluation does not directly apply here.

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