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Powder Free Vinyl Patient Examination Gloves, Colored (White) 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 (White) 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 (White)".

This product is a medical device (patient examination gloves), which falls under a different regulatory and testing paradigm than AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test/training sets, adjudication methods, MRMC studies, and ground truth for AI) are not applicable.

However, I will provide the information based on the provided text, indicating "Not Applicable" where appropriate for an AI/SaMD context.

Acceptance Criteria and Study for "Powder Free Vinyl Patient Examination Gloves, Colored (White)"

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

• Sample Size: Not explicitly stated as this is a physical product test. The standards (ASTM, CFR) define sampling plans for lot release and quality control, but specific sample sizes for this submission are not provided.
• Data Provenance: The device meets ASTM standards and CFR regulations, implying internal testing by the manufacturer (TANGSHAN ZHONGPU PLASTIC PRODUCTS CO.,LTD. in China) and verified through accredited testing processes. The studies are non-clinical (laboratory/physical testing, biocompatibility studies).

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

• Not Applicable. This is a physical product (gloves) for which "ground truth" in the AI/SaMD sense is not relevant. Performance is determined by objective measurements against established engineering and biocompatibility standards.

4. Adjudication method for the test set

• Not Applicable. Adjudication is not relevant for objective physical and chemical properties testing. Results are typically pass/fail or quantitative measurements against specified limits.

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/SaMD device.

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

• Not Applicable. This is not an AI/SaMD device.

7. The type of ground truth used

• Established Standards and Objective Measurements: The "ground truth" for this device's performance is defined by the requirements of recognized standards such as:
  • ASTM standard D 5250-06 (for dimensions, physical properties, powder residual)
  • 21 CFR 800.20 (for freedom from pinholes)
  • ASTM D 6124-06 (for powder residual)
  • ISO 10993-10 (for biocompatibility testing methodology, specifically primary skin irritation and dermal sensitization)

8. The sample size for the training set

• Not Applicable. This is not an AI/SaMD device, so there is no "training set."

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

• Not Applicable. This is not an AI/SaMD device.

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