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A sterile disposable device intended for medical purpose that is worn on the examiners hand to prevent contamination between patient and examiner.

SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves examination gloves are sterile disposable device intended for medical purposes that is worn on the examiners hand to prevent contamination between patient and examiner.

The SYNSATION® Sterile Powder Free, Polyvinyl Chloride Medical Examination Gloves undergo a performance study to demonstrate that they meet the acceptance criteria. The study ensures that the gloves conform to the specified standards and are safe and effective for their intended medical purposes.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size used for each test. However, the performance is reported against ASTM standards, which would imply that testing was conducted according to the sampling plans outlined within those standards. The data provenance is not specified in terms of country of origin, but the testing is non-clinical. The studies are assumed to be prospective, specifically designed to test the glove's performance against the established standards.

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 device is a medical examination glove, and its performance is evaluated against established material and safety standards (ASTM standards and biocompatibility tests), not against expert clinical ground truth like in a diagnostic device. The "ground truth" here is the pass/fail criteria defined by the objective standards themselves.

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

This information is not applicable as the evaluation involves objective measurements against predefined standards rather than subjective expert interpretation requiring 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 information is not applicable. The device is a medical examination glove, which is a physical barrier device, not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is a medical examination glove, not an algorithm.

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

The "ground truth" for the performance evaluation of these gloves is defined by:

• Established ASTM Standards: These are objective measurement criteria for physical properties (dimensions, tensile strength, elongation), freedom from holes, and powder residue.
• Biocompatibility Test Standards: These are established protocols for assessing primary skin irritation in rabbits and sensitization in guinea pigs, yielding objective pass/fail results.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical glove and does not involve AI algorithms that require a "training set."

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

This information is not applicable, as there is no training set for this type of device.

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