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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 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 text describes the acceptance criteria and performance data for the "Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color." This is a medical device, and the information is presented in the context of a 510(k) premarket notification for demonstrating substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and reported device performance:

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

• Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for dimensions, pinholes, etc.). It refers to meeting the requirements of the ASTM standards, which typically specify sample sizes for testing, but these are not enumerated in this summary.
• Data Provenance: The data is reported by Minghao Medical Products Co., Ltd., which is based in China. The data appears to be retrospective in the sense that it describes tests already conducted to qualify the product against established standards.

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

• This type of device (patient examination gloves) does not involve "experts" establishing a 'ground truth' in the way a diagnostic AI device would. The "ground truth" is established by adherence to recognized international and national standards (ASTM, ISO, 21 CFR). The testing is performed in laboratories according to the specified methodologies within those standards.
• Therefore, the concept of a number of experts and their qualifications for ground truth in this context is not applicable.

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

• Again, for this type of medical device and the tests performed (physical, chemical, biocompatibility), the concept of an adjudication method among experts is not applicable. The results are quantitative measurements against defined thresholds or qualitative assessments (e.g., "non-irritating") based on established 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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human readers interpret medical images or data. Examination gloves are a physical barrier device, not an AI diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This is not an AI device. The "device performance" refers to the physical and biological characteristics of the glove itself, not an algorithm's output.

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

• The "ground truth" for this device's performance is defined by the established specifications within the referenced ASTM and ISO standards and FDA regulations (e.g., 21 CFR 800.20). For example, for pinholes, the ground truth is "AQL 2.5" as defined by a specific test method. For physical properties, it's specific tensile strength and elongation values. For biocompatibility, it's the absence of irritation or sensitization as determined by standardized biological tests. This is a form of standard-based ground truth / laboratory test results.

8. The sample size for the training set:

• Not applicable. This device is not an AI algorithm that requires a "training set." The manufacturing process for gloves is typically validated through process controls and quality assurance testing against specifications, not machine learning training.

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

• Not applicable. As there is no training set, there is no ground truth established for one.

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