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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 powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

This document is a 510(k) premarket notification for a medical device: a powder-free nitrile examination glove. It demonstrates substantial equivalence to a predicate device, not the performance of an AI-powered diagnostic device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth for an AI/diagnostic study is not applicable to this document.

For context, here's what aspects of a glove would be tested and reported on, which is very different from an AI/diagnostic device:

Acceptance Criteria and Device Performance (for a glove, as per the document):

Here's why the other requested information is not present in this document:

1. Sample size used for the test set and the data provenance: For a physical product like a glove, "test set" refers to the number of gloves sampled for various physical and chemical tests (e.g., 315 for watertightness, 5 for residual powder). This is not a "data provenance" in the sense of patient data; the "data" comes from the physical product itself. The provenance would be the manufacturing site (Malaysia). These are product quality tests, not clinical studies.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a glove relies on standardized test methods (ASTM, ISO) and laboratory measurements of physical properties, not expert human interpretation.
3. Adjudication method: Not applicable for physical product testing.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: "No clinical study is included in this submission" (Page 13). This type of study is relevant for diagnostic devices (especially AI-powered ones) to assess human performance with and without AI assistance, not for a simple examination glove.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
6. The type of ground truth used: For this device, "ground truth" is established through adherence to recognized international standards for glove manufacturing and testing (e.g., ASTM, ISO standards). For biocompatibility, it's lab test results (e.g., cytotoxicity, irritation, sensitization).
7. The sample size for the training set: Not applicable. This is a physical product, not an AI model that requires a training set.
8. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is a regulatory submission for a physical medical device (examination glove) demonstrating substantial equivalence, not a study validating an AI/diagnostic device. Therefore, the specific criteria for assessing an AI/diagnostic device's performance are not found in this type of document.

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