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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) 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 5250-06e1.

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

Device: Powdered Vinyl Patient Examination Gloves, Clear (non-colored)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility).

The data provenance is for a device manufactured by "Hebei Shenzichen Plastic& Rubber Products Co.,Ltd." in "Ciyutuo Development Area,Luan County,Tangshan City,Hebei Province,063100,China". All data appears to be retrospective as it's presented as results of tests already conducted to demonstrate compliance with established standards.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not provided in the document. The tests described are laboratory-based and standard-driven (e.g., ASTM, CFR, ISO). While technicians with specific qualifications would have performed these tests, the concept of "experts establishing ground truth" in the diagnostic or clinical sense, with defined numbers and qualifications (e.g., radiologists), does not apply directly to the evaluation of a medical device like examination gloves against mechanical and biological standards.

4. Adjudication Method for Test Set

Not applicable in the context presented. The tests performed are objective, standards-based evaluations (e.g., measuring dimensions, physical properties, pinhole presence, powder amount, and biological responses in animals). There is no indication of human interpretation or disagreement requiring an adjudication process for these types of tests.

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 typically conducted for diagnostic or interpretive AI systems where human readers interpret medical images or data. The device in question is a physical medical glove and does not involve human interpretation of output.

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

Not applicable. This device is a passive medical device (an examination glove) and does not involve an algorithm or AI. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used (Test Set)

The ground truth used for the test set is based on:

• Established Industry Standards: ASTM standard D 5250-06 e1 and D6124-06 for physical properties, dimensions, and powder amount.
• Regulatory Standards: 21 CFR 800.20 for freedom from pinholes.
• International Biological Evaluation Standards: AAMI / ANSI / ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).

These standards define the objective pass/fail criteria.

8. Sample Size for the Training Set

Not applicable. The device is a physical product (a glove), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The manufacturing process is likely subject to quality control and statistical process control, but this is distinct from an AI training set.

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

Not applicable for the same reasons as #8. There is no training set for this type of device.

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