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The Skybreeze Zero Nitrile Powder-Free Exam 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 the following chemotherapy drugs: Cyclophosphamide (20.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Etoposide (20.0 mg/ml), 5-Fluorouracil (50.0 mg/ml), Paclitaxel (Taxol) (6.0 mg/ml), Cisplatin (1.0 mg/ml), Dacarbazine (10.0 mg/ml), Ifosfamide (50.0 mg/ml), Mitoxantrone (2.0 mg/ml), Vincristine sulfate (1.0 mg/ml), Carmustine (3.3 mg/ml), ThioTEPA (10.0 mg.ml). Warning: Not for Use with: Carmustine, ThioTEPA.

The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs are disposable, blue-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves packed in a cardboard dispenser box.

The provided text is related to the 510(k) premarket notification for "SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs." This document outlines the safety and performance characteristics of medical exam gloves, not artificial intelligence (AI) software. As such, information regarding AI-specific criteria like multi-reader multi-case (MRMC) studies, sample sizes for AI training sets, or the number of experts for AI ground truth establishment is not present.

However, I can extract information related to the acceptance criteria and studies for the medical exam gloves as described in the document.

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

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

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) for each specific test (e.g., how many gloves were tested for chemotherapy permeation, holes, etc.). However, it refers to industry standards (ASTM, ISO) which define appropriate sample sizes for such tests.
• Data Provenance: The studies were conducted by the manufacturer, O & M Halyard, Inc., to evaluate their product. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying compliance with U.S. regulatory standards. The studies are prospective in nature, as they are part of the premarket notification process for a new device.

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 information is not applicable. The product is a medical exam glove, and the "ground truth" for its performance is established through standardized laboratory testing against physical, chemical, and biological properties, not through expert human interpretation of data like in an AI study.

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

This is not applicable as the studies involve laboratory testing and not human interpretation or adjudication.

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:

This is not applicable since the document refers to a medical device (exam gloves), not an AI algorithm.

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

This is not applicable.

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

The "ground truth" for the device's performance is established by objective, standardized laboratory test methods and their defined pass/fail criteria. For example:

• Chemotherapy Permeation: Measured breakthrough time of specific chemicals using analytical methods.
• Hole Detection: Visual inspection or water leak test methods defined in ASTM D5151-06.
• Residual Powder: Gravimetric analysis as per ASTM D6124-06.
• Physical Properties: Mechanical testing (tensile strength, elongation) as per ASTM D6319-10.
• Biocompatibility: In vitro or in vivo tests for toxicity, irritation, and sensitization as per ISO 10993 standards.

8. The sample size for the training set:

This is not applicable as the document does not describe an AI device with a training set.

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

This is not applicable as the document does not describe an AI device with a training set.

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