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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.

Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided text describes a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)" and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria in the typical sense for an AI/ML medical device. Instead, it details performance characteristics against established ASTM standards and ISO guidelines for medical gloves.

Here's how to interpret the request in the context of the provided document:

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

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

• The document does not specify sample sizes for the individual tests (e.g., freedom from pinholes, tensile strength, etc.). It only states that the device "meets requirements per ASTM..." standards.
• The data provenance is not explicitly stated. The tests are framed as conformance to international standards (ASTM, ISO), which are generally performed in a controlled laboratory setting. The manufacturer is Feiyue Glove Co., Ltd., based in Hebei Province, China, so it's reasonable to assume the testing was conducted or overseen in that region. The studies are not described as retrospective or prospective in the medical imaging sense; they are laboratory-based performance tests of a manufactured product.

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 information is not applicable to this type of device and study. The "ground truth" here is objective physical and chemical properties measured against established industry standards (ASTM, ISO). There are no human experts establishing ground truth in the context of diagnostic interpretation as would be seen in AI/ML medical devices. The "experts" would be laboratory technicians or engineers qualified to perform the specific ASTM/ISO tests.

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data, and there are disagreements that need to be resolved to establish a consensus ground truth. For performance testing of a physical medical device against a standard, objective measurements are taken, and adjudication in this manner is not required.

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. MRMC studies are specifically designed for evaluating diagnostic devices, often AI-powered, by comparing the performance of multiple human readers with and without AI assistance across multiple cases. The provided document is for a non-AI, physical medical device (examination gloves).

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

• This is not applicable. This describes an AI/ML algorithm's performance without human intervention. The device in question is a physical glove, not an algorithm. The reported performance is inherently "standalone" in that it pertains to the glove's intrinsic properties.

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

• The "ground truth" for this device's performance is defined by established industry standards and specifications:
  • ASTM D5250-06 (Reaffirmation 2011) for physical properties (dimensions, tensile strength, elongation).
  • ASTM D5151-06 (Reapproved 2011) for freedom from pinholes.
  • ASTM D6124-06 (Reaffirmation 2011) for residual powder.
  • 21 CFR 800.20 for waterleak test on pinhole AQL.
  • ISO 10993-10:2002/Amd.1:2006 (or the updated 2010 edition) for biocompatibility (skin irritation and sensitization).
• These standards specify the methodology and acceptable limits for various performance metrics, which serve as the "ground truth" for evaluating the glove.

8. The sample size for the training set

• This is not applicable. Training sets are relevant for AI/ML models. This document describes a manufactured product, and the "training" involves manufacturing processes and quality control to ensure the product consistently meets specifications, not an algorithmic learning process.

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

• This is not applicable. As mentioned above, there is no "training set" in the context of an AI/ML device. The "ground truth" for the performance of the manufactured gloves is established by their adherence to the specified ASTM and ISO standards during production and quality assurance testing.

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