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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250. Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard DS250-06.

The provided text describes a 510(k) submission for "Zibo Yingbo Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free". This document is for a medical device that is a glove, not an AI-powered diagnostic device. Therefore, the questions related to AI-powered diagnostics (such as ground truth, expert adjudication, MRMC studies, training/test sets, etc.) are not applicable in this context.

Here's an analysis based on the information provided, focusing on the quality and performance of the gloves:

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

2. Sample size used for the test set and the data provenance

• Sample Size: The document mentions "Inspection Level S-2, AOL 2.5" for Physical and Dimensional Testing and "AOL 2.5, Inspection Level I" for the FDA 1000 ml Water Fill Test. These refer to Acceptance Quality Limit (AQL) standards, which define the maximum percentage of defective units acceptable in a lot. They imply a sampling plan rather than a fixed sample size. The exact number of gloves tested for each lot is not explicitly stated but is determined by the AQL standard and lot size.
• Data Provenance: Not explicitly stated as country of origin for data, but the company is based in Zibo, Shandong, China. The testing was conducted to ASTM and FDA standards. The nature of the tests (physical, chemical, biocompatibility) means the "data provenance" is typically the lab where the tests were performed.

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

• Not applicable. This is not an AI diagnostic device that requires expert-established ground truth. The "ground truth" for gloves is adherence to physical, chemical, and biological performance standards.

4. Adjudication method for the test set

• Not applicable. This is not an AI diagnostic device. Performance is determined by standardized test results against predefined criteria, not by human adjudication of diagnostic outputs.

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 diagnostic device, and therefore no MRMC study was performed.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for the gloves' performance is based on standardized laboratory test results that demonstrate compliance with established industry standards (ASTM D-5250-06) and regulatory requirements (FDA 1000 ml Water Fill Test, biocompatibility tests).

8. The sample size for the training set

• Not applicable. This is not an AI algorithm, so there is no training set.

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

• Not applicable. This is not an AI algorithm, so there is no training set or associated ground truth.

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