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Nitrile Powder Free Patient Examination Gloves, Blue Color is a 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.

Nitrile Powder Free Patient Examination Gloves, Blue Color is a 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. Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) premarket notification for Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color. It describes the device, its intended use, and a study to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study, structured as requested:

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 sample size used for the test set of the device's performance characteristics. It references compliance with ASTM standards, which would imply that the testing was conducted according to the sampling plans outlined within those standards for things like AQL (Acceptable Quality Level) for pinholes.

The data provenance is not explicitly stated in terms of country of origin for the testing, but the company itself is based in China. The testing appears to be prospective as it's being conducted on the subject device to gain regulatory clearance.

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

This information is not provided in the document. The testing described for this device (patient examination gloves) relies on standardized physical, chemical, and biological tests rather than expert consensus on diagnostic images or clinical outcomes. For example, biocompatibility testing (skin irritation, sensitization) would typically be performed in a laboratory setting by trained toxicologists or biologists, but the number and specific qualifications of these individuals are not detailed in this regulatory submission.

4. Adjudication Method for the Test Set

This information is not applicable to the type of device and testing described. Adjudication methods like 2+1 or 3+1 typically apply to studies where multiple human readers are interpreting data (e.g., medical images) and their disagreements need to be resolved to establish ground truth. The tests for these gloves are objective measurements against established 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, not for basic medical devices like examination gloves. The document explicitly states: "Clinical data was not needed for this submission."

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

Not applicable. This device is an examination glove, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective performance specifications defined by recognized consensus standards (e.g., ASTM D6319-10, ASTM D6124-06, 21 CFR 800.20, ISO 10993-10). For example, for "Freedom from pinholes," the ground truth is whether the glove meets the AQL 2.5 requirement as tested according to ASTM D5151-06. For "Biocompatibility," the ground truth is the scientific conclusion from standardized animal or in vitro tests regarding irritation and sensitization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm.

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