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The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

This document describes the performance testing for a medical device: "Nitrile Patient Examination Glove" (K222527). The tests demonstrate that the device meets established acceptance criteria, primarily through non-clinical performance testing.

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

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

• Freedom from Holes: 125 gloves were tested.
• Biocompatibility (Irritation, Sensitization, Cytotoxicity), Powder Content, Dimensions, Physical Properties: The document does not specify the exact sample size for each of these tests, but it indicates that tests were performed according to the referenced ASTM and ISO standards, which typically include specific sampling plans. For instance, ASTM D6319 for dimensions requires a certain number of gloves per lot for testing.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the submitter's address is in China and the nature of the device (examination gloves), it is likely that the testing was conducted by or on behalf of the manufacturer, presumably in adherence to international standards.

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

This document describes technical and biological performance testing for medical gloves, not an AI or imaging device that requires expert human interpretation for ground truth. Therefore, there were no "experts" in the sense of radiologists or clinicians establishing ground truth for diagnostic accuracy in a test set. The "ground truth" for these tests is defined by the objective measurements obtained through standardized laboratory procedures (e.g., tensile strength, dimensions, chemical analysis, in vitro/in vivo biocompatibility assays).

4. Adjudication method for the test set

Not applicable. As noted above, this device did not involve human interpretation or subjective assessment that would require an adjudication method. The test results are quantitative measurements against predefined criteria.

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/imaging device, therefore, no MRMC study was conducted.

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

Not applicable. This is not an AI/imaging device, therefore, no standalone algorithm performance testing was conducted.

7. The type of ground truth used

The ground truth used for these tests is based on:

• Physical Measurements: Objective measurements of dimensions (length, width, thickness), tensile strength, and elongation according to ASTM standards.
• Chemical Analysis: Quantitative measurement of residual powder content.
• Biological Assays: Standardized in vitro (cytotoxicity) and in vivo (irritation, sensitization on animals) biological tests using established protocols (ISO 10993 standards) where the "ground truth" is the observed biological response compared to predefined thresholds.
• Defect Detection: Water leakage test for freedom from holes.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no training set in the AI context. The manufacturing process for gloves is subject to quality control and batch testing, rather than an AI training and validation paradigm.

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

Not applicable, as there is no training set.

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The Nitrile Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

The provided text is a 510(k) Premarket Notification from the FDA for Nitrile Patient Examination Gloves. It details the device's characteristics and its comparison to a predicate device, focusing on physical properties, safety, and compliance with established standards.

The request asks for information regarding acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/ML-driven medical device, including aspects like sample sizes, expert involvement, ground truth, and MRMC studies.

However, the provided document DOES NOT describe an AI/ML-driven device. It describes a physical medical device: Nitrile Patient Examination Gloves. Therefore, much of the requested information (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance, AI assistance effect size) is not applicable to this document.

I will focus on the applicable aspects of the request based on the provided document.

Acceptance Criteria and Study for Nitrile Patient Examination Glove

The study described is a non-clinical performance and safety testing of the Nitrile Patient Examination Glove to demonstrate its substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a detailed table in Section 8.0, "Discussion of Non-clinical and Performance Testing," outlining the acceptance criteria and results.

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

• Sample Size: The document explicitly states "0/125 leaks" for the Watertightness Test. This indicates a sample size of 125 units for that specific test. For other tests (e.g., physical dimensions, tensile strength, cytotoxicity, irritation, sensitization), the exact sample sizes are not explicitly stated in the provided text, but results are given in ranges or as definitive passes (e.g., "15.0-17.9" for tensile strength, suggesting multiple measurements).
• Data Provenance: The tests are described as "Non-clinical tests," implying they were conducted in a laboratory setting by the manufacturer, PingAn Medical Products Co.,Ltd. The company's address is listed in China ("Zheji road ,High-tech Industrial Zone of Hukou County, Jiujiang City, Jiangxi Province,332500 China"). The data is considered prospective as it's generated for the purpose of this premarket notification.

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

This concept is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized test methods (ASTM, ISO) and laboratory measurements, not by expert consensus or interpretations. There's no subjective human interpretation involved in determining if a glove has a hole or meets tensile strength requirements.

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

This concept is not applicable. Adjudication methods are relevant for subjective assessments, typically in image interpretation or clinical diagnosis, where multiple readers might disagree. For physical and chemical property testing of a medical glove, objective measurements against established standards are performed.

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 concept is not applicable as the device is a physical medical glove, not an AI/ML diagnostic tool. There are no human readers or AI assistance involved.

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

This concept is not applicable as the device is a physical medical glove and not an algorithm.

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

The ground truth for this device is based on objective, standardized measurements and laboratory tests defined by international and national standards such as ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, and ISO 10993-10. These standards define the physical, chemical, and biological properties a glove must possess to be considered safe and effective.

8. The sample size for the training set:

This concept is not applicable. This is a physical product, not a software algorithm that requires a training set.

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

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

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