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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 5250-00ed.

Here's an analysis of the provided text regarding the acceptance criteria and study that proves the device meets those criteria:

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

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 sizes used for the specific tests (e.g., freedom from pinholes, physical properties, biocompatibility). It only indicates that the device "Meets" the specified ASTM and CFR standards.

The data provenance is not explicitly mentioned as retrospective or prospective, nor are country of origin of the data. The tests are described as being performed to meet international and US standards (ASTM, 21 CFR, ISO), which implies general laboratory testing rather than data collected from specific patient populations or geographical regions.

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

This information is not provided in the document. For device testing of physical and chemical properties and biocompatibility, the "ground truth" is typically defined by the established testing protocols and acceptance limits within the referenced standards (e.g., ASTM D 5250-00e4, 21 CFR 800.20, ISO10993-10) rather than requiring expert consensus on individual results in the same way clinical image interpretation might. The tests are designed to be objective and measurable.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. For the type of objective physical and chemical testing performed for gloves, adjudication methods like 2+1 or 3+1 are typically not applicable. Results are against predefined criteria from 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 devices that involve human interpretation (e.g., imaging AI). This device is a medical glove, which is a physical barrier device, and its effectiveness is determined by its physical properties and biocompatibility, not by human interpretation or AI assistance.

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

This question is not applicable to the device. The device is a physical medical glove, not an algorithm or an AI-powered system. Therefore, no standalone algorithm performance study was conducted.

7. Type of Ground Truth Used

The "ground truth" for the device's performance is based on objective measurements and predefined criteria as established by recognized industry standards and regulations. Specifically:

• ASTM Standard D 5250-00e4: For Dimension, Physical Properties, and Powder Residual.
• 21 CFR 800.20: For Freedom from pinholes (which relates to the Acceptable Quality Level or AQL for water leak testing).
• ISO 10993-10: For Biocompatibility (Primary Skin Irritation and Dermal Sensitization).

These standards specify the methods of testing and the acceptance limits that define whether a glove "meets" the standard.

8. Sample Size for the Training Set

This information is not applicable and not provided. As a medical glove, the device does not employ machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons mentioned under point 8.

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