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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 the study that proves the device meets them:

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

Predicate Device: FUGUAN (Brand) Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd. (K032908)

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 size used for the test set for any of the performance characteristics. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) is not provided. It only mentions that the data originates from "Hebei Handform Plastic Products Co., Ltd." in P.R. China, but not the specific origin of the test samples or the study design.

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

This information is not provided in the submission. For physical and chemical tests like those listed, ground truth is typically established by laboratory testing methods, not expert consensus in the way it would be for image-based diagnostic devices.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is relevant for studies where subjective interpretation is involved, such as reading medical images. For the physical and chemical tests listed for these examination gloves, adjudication methods are not applicable and therefore not mentioned. The results are objective measurements against defined 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 specific to devices where human readers (e.g., radiologists) interpret cases, and the device aims to assist or improve their performance. The device in question is a medical glove, which does not involve human interpretation in its function.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The "Device performance" column in the table above reflects the algorithm-only performance (in this case, the product's performance) against the specified standards, without human-in-the-loop assistance in the interpretation of results. The device itself is the tested entity, and its performance metrics are directly measured.

7. Type of Ground Truth Used

The ground truth used for the reported performance metrics is based on defined industry standards and regulations:

• ASTM standard D 5250-06: For Dimension and Physical Properties.
• 21 CFR 800.20: For Freedom from pinholes.
• ASTM standard D 5250-06 and D6124-01: For Powder Residual.
• ISO10993-10: For Biocompatibility (Primary Skin Irritation and Dermal Sensitization).

These standards provide the objective criteria against which the device's measured properties are compared.

8. Sample Size for the Training Set

The concept of a "training set" applies to machine learning algorithms. Since these gloves are a physical medical device and not an AI/ML algorithm, there is no training set in the typical sense for this product. The manufacturing process and quality control would involve internal testing, but not "training data" as understood in AI/ML contexts.

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

As there is no training set for this type of device, the question of how its ground truth was established is not applicable.

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