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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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

This document describes the acceptance criteria and the study proving the device meets them for Powder Free Vinyl Patient Examination Gloves, Clear(non-colored).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided summary does not explicitly state the specific sample sizes used for each test (Dimension, Physical Properties, Freedom from Pinhole, Powder Residual, Biocompatibility). It only indicates that the device "Meets" or "Passes" the specified standards.

The provenance of the data is not explicitly mentioned, but the tests were performed by the manufacturer, TANGSHAN HUAMEI HEALTHCARE CO., LTD. in China. The study appears to be an internal validation study conducted by the manufacturer. The document does not specify if the tests were retrospective or prospective, but typically such compliance testing is prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of device (patient examination gloves) does not typically involve expert review for establishing "ground truth" in the same way an AI diagnostic device would. The "ground truth" here is defined by meeting established physical and biocompatibility standards. The tests are laboratory-based and objective measurements against these standards. Therefore, no external experts were used to establish ground truth in the context of clinical interpretation.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations, especially in clinical imaging or diagnostic studies. For the objective, laboratory-based tests conducted on these gloves, such adjudication methods are not applicable. The results are quantitative measurements or pass/fail determinations based on predefined criteria in the standards.

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

No MRMC comparative effectiveness study was done. This type of study is not relevant for patient examination gloves, as they are not diagnostic devices where human readers would be assisted by AI.

6. Standalone Performance Study (Algorithm Only)

No standalone performance study was done. This device is a medical glove, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this study is defined by established consensus standards and regulatory requirements. Specifically:

• Physical properties (dimension, tensile strength, elongation) are measured against criteria specified in ASTM standard D 5250-06.
• Freedom from pinholes is assessed against the criteria in 21 CFR 800.20.
• Powder residual is measured against criteria in ASTM standard D 5250-06.
• Biocompatibility (primary skin irritation and dermal sensitization) is evaluated against standards such as ISO10993-10 and ASTM D6124-01.

8. Sample Size for the Training Set

This device is a physical product (gloves), not a machine learning model. Therefore, there is no "training set" in the context of AI. The "training" in manufacturing involves adherence to Good Manufacturing Practices (GMP) and internal quality control processes to ensure consistent product attributes.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. For manufacturing quality control, the "ground truth" for ensuring consistent product quality would be established by the specifications and tolerances derived from the ASTM and CFR standards, which guide the manufacturing process and in-process quality checks.

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