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ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided document describes the FDA 510(k) summary for ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). This is a medical glove, which is a Class I device and does not involve AI/ML. Therefore, many of the typical questions regarding AI/ML device studies are not applicable.

Here's the information that can be extracted from the document based on your request:

1. A table of acceptance criteria and the reported device performance

Study demonstrating device meets acceptance criteria:

The device's performance against the acceptance criteria is demonstrated through non-clinical performance data which includes testing according to:

• ASTM D5250-06 (Reapproved 2011) for physical properties and dimensions.
• ASTM D6124-06 (Reaffirmation 2011) for powder residue.
• 21 CFR 800.20 (and ASTM D5151-06) for freedom from pinholes.
• ISO 10993-10:2010-08-01 for biocompatibility (primary skin irritation and dermal sensitization).

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

This information is not detailed in the provided document. The summary only states that the device "meets" the standards, implying that the required samples for each test within those standards were used. The document does not specify the exact sample sizes, country of origin, or whether the tests were retrospective or prospective.

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)

This is not applicable as the device is a physical medical glove, and its performance is evaluated through standardized physical, chemical, and biological testing, not through expert review of data like in AI/ML systems.

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

This is not applicable for the evaluation of a medical glove. Performance is determined by meeting objective standards (e.g., tensile strength, pinhole AQL), not by expert adjudication of findings.

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

This is not applicable as the device is a medical glove and not an AI/ML diagnostic tool.

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

This is not applicable as the device is a medical glove and does not involve an algorithm.

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

The "ground truth" for this device's performance is established by objective measurements and observations against the specified international and national standards (ASTM, ISO, CFR). For example:

• Dimensional measurements (length, width, thickness) are measured directly.
• Physical properties (tensile strength, elongation) are determined through standardized mechanical testing.
• Freedom from pinholes is assessed via water leak tests as specified in 21 CFR 800.20 and ASTM D5151.
• Powder residue is measured gravimetrically.
• Biocompatibility (skin irritation, sensitization) is determined through in-vivo animal testing protocols defined by ISO 10993-10, where the "ground truth" is the observed biological response to the device material.

8. The sample size for the training set

This is not applicable as the device is a medical glove and does not utilize a training set like an AI/ML device.

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

This is not applicable as the device is a medical glove and does not utilize a training set.

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