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The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.

The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.

This document, K221983, is a 510(k) Premarket Notification for Biodegradable Powder Free Nitrile Examination Gloves. The device in question is a Class I medical device, meaning it is subject to general controls and typically does not require extensive clinical studies for clearance if substantial equivalence to a predicate device can be demonstrated.

Based on the provided text, the "device" is a Nitrile Examination Glove, not an advanced AI or diagnostic device that would involve AI-assisted reading or complex image analysis. Therefore, the questions related to AI (e.g., effect size of human readers improving with AI, standalone algorithm performance, training set size, adjudication methods, number of experts for ground truth) are not applicable to this type of medical device submission.

The "study" referenced in this document is a series of non-clinical, in-vitro laboratory tests performed to demonstrate that the glove meets established industry standards and specifications, proving its safety and performance equivalence to a legally marketed predicate device.

Here's the information extracted from the document relevant to your request, but tailored to the nature of this Class I device:

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

2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes or dimensions). However, the tests are in accordance with the specified ASTM and ISO standards, which typically define appropriate sample sizes for such tests.
Data provenance: The testing was conducted by Guangdong Kingfa Sci. & Tech. Co., LTD., based in China. The data likely comes from laboratory testing conducted directly by or for the manufacturer. The data is retrospective in the sense that it was collected prior to the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the device. Ground truth for glove testing is established through physical measurements, chemical analysis, and standardized biological tests conducted in laboratories, not by expert consensus of human readers. The "experts" would be the certified laboratory technicians and scientists performing the tests according to the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical image reading. The testing for gloves involves objective measurements and standardized protocols.

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-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.

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 test results defined by internationally recognized standards (ASTM, ISO). For example, a glove has a physical dimension (e.g., length, width), a certain tensile strength, or a specific level of powder residue, as measured by precise instruments and chemical analyses. Biocompatibility (irritation, sensitization, systemic toxicity) is determined by in-vivo/in-vitro assays according to ISO standards.

8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.

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