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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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)".

It's important to note that this document is a 510(k) summary for a Class I medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive clinical studies with human subjects. Therefore, many of the typical AI/ML study questions won't be directly applicable as this is a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in terms of an 'n' count for the tests. However, the tests are performed according to recognized standards (ASTM, ISO, CFR) which inherently define sampling plans. For instance, 21 CFR 800.20 for freedom from pinholes typically involves inspection of a specific number of gloves per lot (often based on AQL – Acceptable Quality Limit).
• Data Provenance: The data is generated from testing the manufactured gloves as per the specified standards. This is prospective in the sense that the manufacturer tests their product. The country of origin of the device manufacturer is Tangshan, China.

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

• Number of Experts: Not applicable in the context of this device and study type. The "ground truth" for the physical and biocompatibility properties are defined by established international and national standards (ASTM, ISO, 21 CFR).
• Qualifications of Experts: The assessment relies on the expertise of personnel qualified to conduct tests according to these standards (e.g., lab technicians, quality control engineers) and interpret the results against the defined acceptance limits.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The results are objective measurements against predefined thresholds within the standards. There is no subjective interpretation requiring adjudication among experts.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret results, often with and without AI assistance. This document pertains to a physical examination glove, for which such a study is not applicable.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI-driven device. The "performance" refers to the physical and chemical properties of the glove.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on established industry standards and regulatory requirements. These standards define measurable parameters (e.g., tensile strength, elongation, freedom from pinholes, powder residue limits, biocompatibility test results) and their acceptance limits.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The manufacturing process of the gloves would have internal quality control procedures and potentially process validation steps, but these are distinct from "training a model."

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

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