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Rhino Non-Sterile Powder-Free Nitrile Patient Exam Glove - Blue Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Blue Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

This document describes the performance of a medical glove, not an AI device. Therefore, several requested categories are not applicable. Here's a breakdown of the requested information based on the provided text, focusing on the glove's performance:

1. Table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Physical Tests (ASTM D6319):
  • Freedom from holes: 50 gloves for Medium size, 50 and 100 gloves for Large size. (Implies multiple samples were taken and tested to demonstrate this AQL).
  • Specific sample sizes for other D6319 tests (Ultimate elongation, Tensile strength, Thickness, Palm Width, Length, Powder-Free) are not explicitly stated by number, but assumed to be sufficient for ASTM standard compliance, likely involving multiple gloves per size.
• Sample Size for Chemotherapy Permeation (ASTM D6978): Not explicitly stated, but per ASTM D6978, at least three specimens (gloves) should be tested for breakthrough time for each chemical.
• Sample Size for Biocompatibility (ISO 10993-10, ISO 10993-11):
  • ISO 10993-11 Systemic Toxicity: "Albino Swiss mice" (number not specified, but typically multiple mice per extract and control group).
  • ISO 10993-10 Primary Skin Irritation: "New Zealand white rabbits" (number not specified, but typically multiple rabbits).
  • ISO 10993-10 Guinea Pig Sensitization: "test animals" (number not specified, but typically multiple guinea pigs).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Non-clinical testing typically involves prospective laboratory studies.

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)

Not applicable. This is a non-clinical performance evaluation of a physical device against established ASTM and ISO standards, not an AI device requiring human expert ground truth for interpretation. The "ground truth" here is the measurement against the specified standard criteria.

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

Not applicable. This is a non-clinical performance evaluation against standardized laboratory tests; there is no human interpretation or adjudication in the sense of comparing opinions. The results are quantitative measurements against objective criteria specified by the standards.

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 document pertains to a medical glove, not an AI device.

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

Not applicable. This document pertains to a medical glove, not an AI device.

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

The "ground truth" for the device's performance is defined by adherence to established international and national standards for medical gloves and testing protocols:

• ASTM D6319-19: Standard Specification for Nitrile Examination Gloves for Medical Application
• ASTM D6978-05: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
• ISO 10993-11: Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity
• ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

These standards specify the methodologies, acceptance/rejection criteria, and measurement techniques. The "ground truth" is therefore derived from the objective measurements obtained through these standardized tests.

8. The sample size for the training set

Not applicable. This document pertains to non-clinical testing of a physical device, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a medical device that is not AI/ML based.

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