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Powder free 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.

powder free vinyl patient examination gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)":

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the test set for any of the performance characteristics. It refers to compliance with standards (ASTM D 5250-06, 21 CFR 800.20, D6124-06, and ISO10993-10), which would detail the required sample sizes for testing.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that the manufacturer is "Hebei Hongtai Plastic Products Co.,Ltd." in China, it is highly probable the testing was conducted in China. The testing appears to be prospective, as it's to demonstrate compliance of the manufactured device.

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

This information is not provided in the document. The standards mentioned define the test methodologies, but not the specific experts involved in evaluating the results or their qualifications. For device performance like glove characteristics, "ground truth" is typically established by the results of standardized physical and chemical tests, rather than expert consensus on subjective evaluations. For biocompatibility, the interpretation of the animal study results would be done by qualified toxicologists or pathologists, but the text doesn't specify who performed this interpretation or how many.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (mechanical, chemical, and animal biocompatibility), an adjudication method in the sense of multiple human readers or subjective evaluations is generally not applicable. The results are typically objectively measured against defined pass/fail criteria within the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or subjective interpretation tasks involving human readers, which is not applicable to patient examination gloves.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

N/A. This device is a physical product (gloves), not an algorithm or AI system. Therefore, the concept of a "standalone" algorithm performance does not apply.

7. Type of Ground Truth Used:

The ground truth used is primarily compliance with established industry standards and regulations. Specifically:

• Mechanical and Physical Properties: Defined specifications within ASTM standard D 5250-06 (e.g., tensile strength, elongation, dimensions).
• Freedom from Pinhole: Defined acceptance quality limits (AQL) in 21 CFR 800.20 (Waterleak test).
• Powder Residual: Defined limits and test methods in ASTM standard D 5250-06 and D6124-06.
• Biocompatibility: Results of animal studies (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig) interpreted against established toxicological criteria, likely guided by ISO 10993-10. The "ground truth" here is the biological response observed and its classification as "Passes" or "Fails" based on established toxicological guidelines.

8. Sample Size for the Training Set:

N/A. This device is a physical product and not an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The "training" for such devices involves setting up manufacturing processes to consistently meet specifications.

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

N/A. As mentioned above, there is no training set for this type of device. The ground truth for manufacturing and quality control would be the same as the acceptance criteria for the final product: adherence to ASTM standards, CFR regulations, and ISO guidelines.

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