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The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - VBLU; Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - ABLU; Blue Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs) - CBLU

This document describes the "Indications For Use" for three types of Nitrile Powder Free Examination Gloves (VBLU, ABLU, CBLU) that have been tested for use with chemotherapy drugs. The acceptance criteria here are the "breakthrough times" for each chemotherapy drug, which indicate how long the glove provides protection against that specific drug. The study mentioned in this document is the testing performed to determine these breakthrough times.

Here's the information broken down as requested, based on the provided text:

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

The acceptance criteria are implicitly that the gloves should demonstrate a breakthrough time for each tested chemotherapy drug. The device performance is the actual breakthrough time measured for each drug.

Note: The "WARNING" and "CAUTION" statements for Carmustine and Thiotepa for VBLU and CBLU, and Carmustine for ABLU, indicate that while a breakthrough time was measured, it might be below generally desired protection levels, leading to specific usage instructions or warnings.

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 (e.g., number of gloves tested for each drug or number of tests conducted) for the breakthrough time study.
The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a submission to the FDA from Malaysia, implying the manufacturer is in Malaysia (Hartalega Sdn. Bhd., located in Java, Selangor, Malaysia), and the testing could have been performed there, but this is not explicitly stated for the test data itself.

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)

This type of study (chemical breakthrough time) does not typically involve human experts establishing a "ground truth" in the way a diagnostic imaging study would. The ground truth is established through standardized laboratory testing protocols, likely following ASTM standards (e.g., ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs," although not explicitly mentioned here). Therefore, there are no "experts" in the sense of clinical decision-makers reviewing results to establish a truth. The "experts" would be the chemists and laboratory technicians performing the standardized tests. Their qualifications are not mentioned.

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

Not applicable. As described above, this is a laboratory test, not a subjective assessment requiring adjudication among multiple human readers.

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 a study involving human readers or AI assistance. It's a physical materials testing study.

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

Not applicable. This is not an algorithm or AI performance study.

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

The ground truth used is the measured breakthrough time of the chemotherapy drugs through the glove material, determined by laboratory-controlled permeation testing (likely a chemical permeation test following recognized standards).

8. The sample size for the training set

Not applicable. This is not a machine learning study, so there is no training set in that context.

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

Not applicable. There is no training set.

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