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A powder free 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. In addition, these gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs

The provided document is a 510(k) premarket notification for "Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs." This is a medical device, and the information supplied primarily concerns its regulatory approval and performance against specific chemical permeation standards, rather than the performance of an AI/ML powered device.

Therefore, many of the requested categories for AI/ML device evaluations (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and ground truth establishment methods) are not applicable to this type of device and document.

However, I can extract the acceptance criteria and reported performance related to its intended use and testing for chemotherapy drug permeation.

Here's the relevant information based on the provided text:

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

The acceptance criteria are implicitly defined by the reported "Minimum Breakthrough Detection Time" for each chemotherapy drug, which are measured according to ASTM D6978-05. Higher breakthrough detection times indicate better performance (i.e., less permeation). While no explicit "acceptance limit" or "pass/fail" threshold is given in the document, the reported values are the established performance of the device against the standard.

Note: The document explicitly states: "Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 9.1 and 36.3 minutes respectively." This serves as a warning regarding the performance for these specific drugs.

The following questions are not applicable to this document as it pertains to a manual medical device (gloves) and not an AI/ML powered device:

• 2. Sample sized used for the test set and the data provenance - Not applicable. Performance is based on standardized testing procedures (ASTM D6978-05) for chemical permeation, not a data-driven test set of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts - Not applicable. The ground truth for chemical permeation is determined by laboratory measurements according to the ASTM standard, not by expert consensus on clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - The "ground truth" here is the physical measurement of chemical permeation obtained through laboratory testing methods as defined by ASTM D6978-05.
• 8. The sample size for the training set - Not applicable. This is a physical device, not an AI model requiring a training set.
• 9. How the ground truth for the training set was established - Not applicable.

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