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Powder Free 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.

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.

This looks like a 510(k) premarket notification for patient examination gloves, which are Class I medical devices. For these types of devices, the regulatory approval heavily relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than a clinical effectiveness study of the kind you might see for an AI diagnostic device.

Therefore, many of the questions you've asked (about AI assistance, ground truth, expert opinions for labelling, effect size, etc.) are not applicable to this document as it describes a physical, non-AI medical device (gloves).

However, I can extract the relevant information regarding acceptance criteria and the study (testing) used to prove the device met those criteria, based on the provided text.

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 each of these physical and biocompatibility evaluations. It refers to meeting ASTM standards, which would imply that the testing was conducted according to the sampling plans specified within those standards.

The data provenance is from non-clinical tests conducted by the manufacturer, Xuanhua Metallurgical Industry Co., Ltd., likely in China, where the company is located. The tests were performed to demonstrate that the device meets established ASTM and ISO standards, and FDA regulations (21 CFR 800.20). These are retrospective tests in the sense that they are conducted on manufactured product batches to ensure compliance.

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

Not applicable. For physical device testing against standards, "ground truth" is established by the specifications in the standards themselves, measured objectively using calibrated equipment and defined procedures, not by expert consensus in a medical diagnostic sense. Biocompatibility tests are also performed in a laboratory setting with established protocols.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against defined physical and chemical criteria. There is no human adjudication process described or implied for these types of tests.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI device.

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

The "ground truth" for this device's performance is adherence to recognized national and international standards and regulations for medical gloves. Specifically:

• Physical Properties: ASTM D5250-06 (Reapproved 2011)
• Freedom from Pinholes: 21 CFR 800.20, ASTM D5151-06 (Reapproved 2011)
• Powder Residual: ASTM D6124-06 (Reaffirmation 2011)
• Biocompatibility: ISO 10993-10:2010-08-01 (for Primary Skin Irritation and Dermal Sensitization)

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no concept of a "training set" in the machine learning sense. The manufacturer's production process would be "trained" or optimized to consistently produce gloves meeting these standards.

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

Not applicable. As above, this is not an AI device. The establishment of "ground truth" (i.e., the standards themselves) for medical devices is through a consensus process by standards bodies (like ASTM and ISO) and regulatory bodies (like FDA), based on scientific evidence, clinical experience, and risk assessment for patient and user safety and efficacy.

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