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Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Viny| Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material , intended for medical purpose that worn on examiner's hand or linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).

Here is an analysis of the acceptance criteria and study information for the device, based on the provided text:

Acceptance Criteria and Device Performance Study

The device in question is the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". Its performance is demonstrated through testing against established ASTM standards and FDA regulations for examination gloves.

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 specific sample sizes for each test mentioned (e.g., how many gloves were tested for pinholes, dimensions, or physical properties). However, the testing refers to compliance with ASTM standards and 21 CFR 800.20. These standards typically define the appropriate sampling plans and statistical methods for demonstrating compliance.

• Data Provenance: The studies were conducted by Bytech Dongtai Co.,Ltd. in China. The results are reported as part of their 510(k) submission to the FDA. The testing conducted to meet ASTM and ISO standards would be considered prospective for the purpose of demonstrating device performance and substantial equivalence.

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

This information is not applicable as the device is a simple medical examination glove. The "ground truth" for its performance is established by objective, quantifiable physical and chemical tests against recognized national and international standards (ASTM, ISO, and 21 CFR). Expert consensus is not typically involved in establishing the ground truth for such device characteristics.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, often in clinical imaging studies where multiple readers interpret results. For physical and chemical properties of a medical glove, performance is measured objectively against predefined thresholds in standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are typically performed for diagnostic devices or AI-driven systems where human interpretation is a critical component, and the impact of the AI on human reader performance is being evaluated. This device is a passive barrier (examination glove), and its effectiveness is determined by its physical and biological properties, not by aiding human readers in diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was implicitly done. The tests conducted (Dimension, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility) are all evaluations of the device itself, independent of any human interaction beyond the execution of the test protocols. The device's performance is measured directly by mechanical, chemical, and biological tests, not by an algorithm or human-in-the-loop scenario.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on objective, quantitative measurements against established engineering and biological standards. Specifically:

• ASTM D 5250-06 (Reapproved 2011) for dimensions and physical properties.
• 21 CFR 800.20 and ASTM D 5151-06 (Reapproved 2011) for freedom from pinholes.
• ASTM D 6124-06 (Reapproved 2011) for powder residual.
• ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).

These standards define the acceptable range or threshold for each characteristic, which serves as the "ground truth" for determining compliance.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires a "training set". Its performance is based on manufacturing processes and material properties, which are then verified through direct testing against standards.

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

This information is not applicable as there is no "training set" for this type of medical device.

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