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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The Powder-Free Nitrile Examination Gloves, Orange is substantial equivalent to Powder-Free Nitrile Examination Gloves, Black Color with 510k number K090194 that is currently marketed. The device modification is a change in color from Black to Orange. Another device modification is the addition of adding a citric acid coating to the interior surface of the gloves to achieve a pH of 5.0 - 5.5 for the inner surface of the glove.

The provided document is a 510(k) Summary for Powder-Free Nitrile Examination Gloves, Orange Color. It describes the device, its intended use, and a summary of technological characteristics compared to standards. The document does not describe a study in the context of an AI/ML medical device with the information requested (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, or specific ground truth types like pathology or outcomes data).

Instead, this document is a submission to the FDA demonstrating substantial equivalence for a medical device (gloves) by confirming its compliance with established performance standards.

Therefore, many of the requested fields cannot be filled from the provided text as they are not applicable to this type of device submission.

Here's an attempt to answer based on the provided document, using "N/A" where information is not present or not relevant to the type of device:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated. The tests are described as conforming to ASTM standards and FDA regulations, which imply specific sample sizes for various tests (e.g., AQL 2.5 for pinholes), but these specific numbers are not detailed in the summary.
• Data Provenance: Not specified, but generally, such tests are performed by the manufacturer or a contracted lab to confirm compliance with regulatory standards.
• Retrospective/Prospective: Not applicable in the context of this device type. These are physical/chemical performance tests.

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

• Number of experts: N/A. The "ground truth" for these tests are the established ASTM standards and FDA regulations.
• Qualifications of those experts: N/A.

4. Adjudication method for the test set

• N/A. Compliance is determined by meeting pre-defined physical and chemical specifications, not by expert 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

• N/A. This is not an AI/ML device, and no MRMC study was conducted.

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

• N/A. This is not an AI/ML device.

7. The type of ground truth used

• The "ground truth" for the device's performance is compliance with established physical, chemical, and biological standards (ASTM D6319-10, ASTM D 6124-06, FDA 21 CFR 800.20, and biocompatibility tests like Primary Skin Irritation and Dermal Sensitization). It is based on pre-defined engineering and regulatory specifications.

8. The sample size for the training set

• N/A. No "training set" in the context of an AI/ML algorithm is applicable to this device.

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

• N/A. No "training set" is applicable.

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