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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Powdered Vinyl Patient Examination Gloves

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 specify a distinct "test set" sample size for each characteristic. It simply states that the device "Meets" the specified standards. For freedom from pinholes, the "waterleak test on pinhole AQL" implies a statistical sampling method as defined by the AQL (Acceptable Quality Level) in 21 CFR 800.20, but the specific sample size, number of defects allowed, or number of units tested are not provided. Similarly for biocompatibility, it's not explicitly stated how many rabbits or guinea pigs were used.
• Data Provenance: The studies appear to be prospective as they were conducted by the manufacturer (Wuxi Shenzhou Plastic Products Co., LTD) to demonstrate that their device meets the requirements.
• Country of Origin of the Data: The manufacturing company is located in Wuxi City, Jiangsu Province, P.R.China. It is reasonable to infer that the testing was conducted in China, though it's not explicitly stated.

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. For physical and chemical tests like dimension, physical properties, powder amount, and pinholes, the "ground truth" is typically established by direct measurement against the specified standard (e.g., using calipers, tensile strength testers, or standardized water leak tests). For biocompatibility, the ground truth is established by trained toxicologists or researchers interpreting the biological responses in animal models, but the number and qualifications of these experts are not explicitly mentioned.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used when there are subjective interpretations involved, often in image-based diagnostics where multiple experts might disagree on a finding. The tests for these gloves (dimension, physical properties, pinholes, powder, biocompatibility) are primarily objective measurements against established standards, not requiring human adjudication in the same way.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for patient examination gloves.

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

No, a standalone algorithm-only performance study was not done. This concept is also not applicable to the device in question (patient examination gloves). The testing performed is to assess the physical, chemical, and biological properties of the glove itself.

7. The type of ground truth used:

• Dimension, Physical Properties, Powder Amount: The ground truth is based on direct measurement and comparison to the specifications outlined in ASTM standard D 5250-00e4.
• Freedom from pinholes: The ground truth is established by a standardized water leak test as per 21 CFR 800.20.
• Biocompatibility: The ground truth is established through animal testing (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) according to ISO10993-10, with results interpreted as "Passes" or "Not a Primary/Dermal Sensitization."

8. The sample size for the training set:

Not applicable/Not provided. This device is a physical product (gloves), not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The manufacturer likely had internal quality control and development data, but this is not a training set for an AI model.

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

Not applicable/Not provided for the same reasons as point 8.

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