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A Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

Blue Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound,Blue colour, powder free and non sterile.

The provided document describes the acceptance criteria and performance of the "EMG Blue Nitrile Medical Examination Gloves Powder Free (Non Sterile)". This is a medical device for patient examination, not an AI or software device. Therefore, many of the requested categories in the prompt, such as those related to AI algorithm performance, human expert involvement, and ground truth establishment, are not applicable.

Here's an analysis of the provided information, focusing on the relevant sections for a medical device:

1. A table of acceptance criteria and the reported device performance

The document provides a detailed comparison table on page 5, which is further summarized on page 7-8.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states that the gloves are manufactured in Malaysia by Eco Medi Glove SDN BHD. However, it does not explicitly mention the sample size used for the tests or the specific provenance of the data generated from these tests (e.g., retrospective or prospective data from a specific country). The tests refer to compliance with ASTM and ISO standards, which would imply that testing was performed according to the methods outlined in those standards.

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)

This is not applicable to a medical examination glove. "Ground truth" in the context of diagnostic AI refers to the confirmed diagnosis or condition, usually established by medical experts or pathology. For a physical device like a glove, the "ground truth" is adherence to established engineering and medical device standards (ASTM, ISO), which is verified through laboratory testing. No medical experts are involved in establishing the "ground truth" for glove characteristics like tensile strength or pinhole presence.

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

Not applicable. Adjudication methods like '2+1' or '3+1' are used for resolving discrepancies in expert opinions during the establishment of ground truth for diagnostic studies, particularly in AI/ML performance evaluation. This is not relevant for the physical testing of a medical glove.

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. An MRMC study involves human readers (e.g., radiologists) interpreting cases, often with and without AI assistance, to measure the AI's impact on their performance. This is irrelevant for a physical medical glove.

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

Not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is a concept for AI/software devices. This document is for a physical medical glove.

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

The "ground truth" for this device is its adherence to universally accepted medical device standards and specifications, specifically ASTM D6319-10 for Nitrile Examination Gloves, and biocompatibility standards like Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 for Primary Skin Irritation Test, and ISO 10993-10:2010(E) for Dermal Sensitization Assay. Compliance with these standards is verified through objective physical and chemical laboratory tests.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train an AI/machine learning model. This is a physical medical device, not an AI.

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

Not applicable. As explained above, this is a physical medical device, not an AI.

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