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The examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder free black nitrile patient examination glove, that meets all the requirements of ASTM standard D6319, except for sterility requirements.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

For the physical and chemical tests (Dimension, Physical Properties, Freedom from Pinholes, Powder Residual), the sample sizes are not explicitly stated in this summary. However, these standards (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06) typically define the sampling plans and quantities required for compliance testing. The data provenance is not explicitly stated in terms of country of origin but is implied to be from testing conducted by or for the device manufacturer to demonstrate compliance with international standards. These tests are generally prospective, in that they are performed specifically to assess the device's adherence to the standard.

For Biocompatibility, the sample sizes are also not explicitly stated in this summary, but ISO 10993-10:2010 would specify the minimum number of animals (rabbits for irritation, guinea pigs for sensitization) for testing. This data is prospectively generated for device testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (patient examination glove) does not typically involve expert review for "ground truth" in the way a diagnostic imaging device would. The "ground truth" for the performance criteria is established by the specifications defined within the referenced ASTM and ISO consensus standards. The "experts" would be the scientists and engineers who developed and validated these standards, and the laboratory personnel performing the tests according to standardized protocols. Qualifications of these personnel are not provided, but they would be expected to be trained and certified in laboratory testing procedures relevant to their specific roles.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. The tests are objective and quantitative, based on standardized measurement protocols and predefined acceptance criteria in consensus standards. There is no subjective interpretation requiring adjudication among human reviewers.

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 a medical device (glove) that does not involve "readers" or artificial intelligence. It's a physical barrier device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (glove) that does not involve algorithms.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the device's performance is the compliance with established, quantitative consensus standards (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10:2010). These standards define objective chemical and physical properties as well as biological responses.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI models, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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