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A patient 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 White, Black, and Purple Examination Gloves

This is a 510(k) clearance letter for Powder Free White, Black, and Purple Nitrile Examination Gloves. The document confirms that the device is substantially equivalent to legally marketed predicate devices. This type of device (medical gloves) is subject to performance standards rather than clinical studies with acceptance criteria as envisioned in your request.

Medical gloves are "general controls" devices, meaning they are primarily regulated through performance standards defined by organizations like ASTM International. The FDA assesses adherence to these standards.

Therefore, your request for acceptance criteria and study details as typically defined for AI/software devices (e.g., sample size for test sets, expert consensus, MRMC studies, effect size of AI assistance) does not apply to this medical device.

Instead, the "acceptance criteria" for these gloves would be their compliance with recognized performance standards, for example, for physical properties, barrier integrity (e.g., freedom from holes), and biocompatibility. The "study" proving this would be laboratory testing against these standards.

However, based on the provided document, here's what can be inferred about the "acceptance criteria" in the context of general controls and performance standards applicable to examination gloves:

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

This document does not contain a table of acceptance criteria or reported device performance for the gloves. For medical gloves, these details would typically be found in the manufacturer's submission which would include test reports demonstrating compliance with relevant ASTM standards (e.g., ASTM D6319-19 for Nitrile Examination Gloves). These standards specify requirements for:

• Tensile strength and elongation: To ensure durability and flexibility.
• Dimensions: Length, palm width, finger thickness.
• Barrier integrity (Freedom from holes): A critical safety aspect, often tested using an AQL (Acceptable Quality Level) for water leak testing.
• Biocompatibility: To ensure the materials are not harmful to users or patients.
• Powder content: For powder-free gloves.

The FDA's clearance letter assumes these tests have been successfully conducted and reported in the 510(k) submission.

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

• Not Applicable in this document. The document does not provide details of specific test sample sizes or data provenance as it is an FDA clearance letter, not the study report itself. For medical gloves, sample sizes for testing (e.g., AQL for pinholes) would be determined by the relevant ASTM standard.

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

• Not Applicable. This is not a diagnostic device where expert ground truth is established. Performance is measured against objective physical and chemical standards.

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

• Not Applicable. See point 3.

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 not an AI/diagnostic device.

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

• Not Applicable. This is not an AI/diagnostic device.

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

• Objective performance standards. For medical gloves, the "ground truth" refers to meeting the scientifically established physical and chemical properties and safety requirements outlined in recognized consensus standards (e.g., ASTM standards).

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. This is not an AI/machine learning device.

In summary: The provided document is an FDA 510(k) clearance for medical gloves. The "acceptance criteria" for such devices are their compliance with recognized performance standards, which are demonstrated through laboratory testing rather than clinical studies with human "ground truth" and reader performance evaluations as would be the case for AI-enabled diagnostic devices.

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