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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.

The proposed device is a disposable device intended for over the counter use. It is not made with natural rubber latex. Instead, the gloves are formulated using vinyl synthetic polymer. The glove is coated with an emollient coating. The gloves are manufactured using molds that are ambidextrous. They are offered powder-free and non-sterile.

The provided document describes the acceptance criteria and performance data for the Cardinal Health™ Vinyl Powder-Free Exam Gloves with Neu-Thera® Coating. This is a medical device application for examination gloves, and therefore the "device" in this context refers to these gloves.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size for each specific test mentioned (e.g., how many gloves were tested for freedom from holes or powder residual). It refers to compliance with ISO and ASTM standards, which would define appropriate sample sizes for these types of tests.

The data provenance is from non-clinical tests conducted by Cardinal Health, Inc. This is prospective testing performed on the device itself. There is no information regarding country of origin for the data beyond being submitted by a US-based company for FDA approval in the US.

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 in this context. The "ground truth" for a medical device like examination gloves is typically established through adherence to recognized international and national consensus standards (like ISO and ASTM) and regulatory requirements (like 21 CFR). These standards define objective, measurable performance criteria. Expert judgment, while informing the development of such standards, is not directly applied on a case-by-case basis to "establish ground truth" for individual glove performance during testing in the way it would be for, say, image interpretation in AI.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used when there's subjective interpretation involved, such as in clinical trials or when establishing ground truth from multiple expert readings. For objective physical and chemical tests of a medical device like gloves, the results are derived directly from the test methods and interpreted against the defined criteria 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

This is not applicable. An MRMC comparative effectiveness study is relevant for AI-powered diagnostic devices or tools that assist human interpreters (e.g., radiologists interpreting images). The device in question is an examination glove, which does not involve human "readers" or AI assistance in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product (gloves) and does not involve any algorithms.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on accepted international and national consensus standards and regulatory requirements. Specifically:

• Biocompatibility: ISO 10993-10 standards.
• Physical Characteristics (Dimensions, Physical Properties, Freedom from Holes, Powder Residual): ASTM D5250, ASTM D5151, ASTM D6124, and 21 CFR 800.20.

These standards define the objective performance benchmarks that the gloves must meet.

8. The Sample Size for the Training Set

This is not applicable. This question refers to the training of an AI model. The device (examination gloves) does not utilize a training set in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as point 8.

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