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Powdered Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powdered Vinyl 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 finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the device, organized according to your requested information:

Description of Acceptance Criteria and Proving Study

This submission describes the acceptance criteria and performance for "Powdered Vinyl Patient Examination Gloves, Clear (non-colored)". The device's performance is demonstrated through nonclinical testing against established ASTM standards and FDA regulations, as clinical data is explicitly stated as not being needed for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

The subsequent points (2-9) are not applicable to this device submission, as it concerns a Class I medical device (patient examination gloves) that relies on nonclinical testing against established standards rather than clinical studies with human participants, expert ground truth, or AI algorithms.

However, I will address each point and explain why it's not applicable in this context.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. The "test set" here refers to physical gloves undergoing nonclinical laboratory tests according to standards like ASTM. While a sample size would have been used for tests like pinhole detection or physical properties, the document does not specify these individual sample sizes. The data provenance is from laboratory testing performed to meet specified standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of expert consensus, is not relevant for this device. The "ground truth" for glove performance is defined by the objective metrics and thresholds established within the referenced ASTM standards and FDA regulations (e.g., specific tensile strength values, acceptable pinhole rates, bio-reactivity tests).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies. This is not pertinent to the nonclinical testing of gloves against predefined physical and chemical standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical glove and does not involve AI, human readers, or image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical glove and does not involve any algorithm or AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this device is based on established industry standards and regulatory requirements.

• For physical properties and dimensions: ASTM standard D 5250-06 e1 dictates the acceptable ranges and performance.
• For freedom from pinholes: 21 CFR 800.20 sets the standard.
• For powder residual: ASTM standard D 5250-06 e1 and D6124-06 set the acceptable limit.
• For biocompatibility: ISO 10993-10 outlines the testing methodology and acceptable outcomes (e.g., "Not a Primary Skin Irritation," "Not a Dermal Sensitization").

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning algorithm, the concept of establishing ground truth for it does not apply.

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