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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.

Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)

This document is a 510(k) clearance letter from the FDA for a medical device: "Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)".

The FDA clearance process for Class I devices like examination gloves primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves performance testing against recognized standards rather than a clinical study with human readers or complex statistical analyses of diagnostic accuracy.

Therefore, many of the requested details, such as multi-reader multi-case studies, expert adjudication methods, and standalone algorithm performance, are not applicable to this type of device clearance.

Here's an attempt to answer the questions based on the information provided and the general understanding of 510(k) for examination gloves:

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

The document itself does not contain a table of acceptance criteria or reported device performance. For examination gloves, acceptance criteria are typically based on recognized international standards such as ASTM D6319 (for nitrile examination gloves) or ISO 11193 (for single-use medical examination gloves), which define requirements for physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from holes).

The FDA's review letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This implies that the device met the performance criteria equivalent to the predicate device, which would mean it complied with the relevant standards for examination gloves.

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 does not specify the sample size or data provenance for any testing. For examination gloves, this would typically involve laboratory testing of a statistically relevant sample size from manufactured lots to demonstrate compliance with physical and barrier properties. This testing is usually prospective, conducted by the manufacturer, and the country of origin would be Malaysia (where the manufacturer is located).

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)

Not applicable. For examination gloves, the "ground truth" is established by direct physical and chemical measurements against defined standards, not by expert interpretation of images or clinical data.

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

Not applicable. There is no adjudication method for the physical and performance testing of examination gloves.

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 device is an examination glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

Not applicable. This device is an examination glove, not an algorithm.

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

For examination gloves, the "ground truth" for performance would be based on objective measurements of physical properties (e.g., tensile strength, elongation at break) and barrier integrity (e.g., water leak test) as defined by recognized consensus standards (e.g., ASTM, ISO).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of device clearance for examination gloves. The manufacturing process is controlled, and product testing ensures consistency.

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

Not applicable. See point 8.

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