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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

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This document is a 510(k) clearance letter for Cardinal Health Nitrile Exam Gloves. While it confirms the device is substantially equivalent to legally marketed predicate devices, it does not contain information about acceptance criteria or a study design in the typical format of an AI/ML device submission.

This type of device (nitrile exam gloves) is a physical medical device, not a software device or an AI/ML product. The "acceptance criteria" and "study" described in the input prompt are typically associated with the evaluation of performance claims for AI/ML algorithms, which involve metrics like accuracy, sensitivity, specificity, and rigorous testing on curated datasets.

Here's what can be extracted and inferred from the provided text, acknowledging that it doesn't align with the detailed AI/ML study request:

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

The closest information provided is the permeation resistance to chemotherapy drugs as tested per ASTM D6978. This acts as a performance standard for this specific "indication for use."

Note: The "acceptance criteria" here are implied by the testing standard ASTM D6978 and the explicit warnings for drugs with low permeation times. For most drugs, " >240 minutes" appears to be the desired performance, and the device meets this for the majority. For Carmustine and Thiotepa, where performance is lower, specific warnings are issued.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. The ASTM D6978 standard would dictate the number of gloves tested.
• Data Provenance: Not specified, but generally for such testing, it would be laboratory testing conducted according to the ASTM standard. It's not "country of origin of data" in the sense of patient data, nor is it retrospective or prospective as it's a materials performance test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a diagnostic device requiring expert interpretation of medical images or data. The "ground truth" here is the physical permeation time measured by laboratory equipment following the ASTM D6978 standard.

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

• Not applicable. This refers to consensus building among experts for tasks like image labeling or diagnosis, which is not relevant for glove permeation testing.

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. The device is a physical medical glove, not an AI/ML diagnostic aid.

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

• Not applicable. The device is a physical medical glove, not an AI/ML algorithm.

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

• The ground truth is the measured breakthrough detection time for each chemotherapy drug, obtained through standardized laboratory testing (ASTM D6978).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

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