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A patient Examination Powder-Free Polymerisation 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.

Patient Latex Examination "Powder-Free" Trade Name: Polymer Coated Gloves

The provided document is a 510(k) premarket notification letter from the FDA regarding "Patient Latex Examination 'Powder-Free' Polymer Coated Gloves" by Wear Safe Malaysia Sdn. Bhd.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of medical device validation for performance or effectiveness.

Instead, the letter:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Allows Wear Safe Malaysia Sdn. Bhd. to market the device subject to general controls provisions of the Act.
• Provides information on regulatory compliance (GMP regulations, labeling, promotion, and advertising).

Therefore, I cannot extract the requested information from this document. The sections you asked for, such as:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

are not present in this regulatory correspondence. Such details would typically be found in the 510(k) submission itself (which includes test reports, studies, and data) but are not generally summarized in the FDA's decision letter.

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