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DAIYANG 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.

The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

The provided document is a 510(k) summary for the "DAIYANG Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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 explicitly state the sample sizes used for each test. It refers to established ASTM and 21 CFR standards (e.g., AQL levels for pinholes) which would imply specific sampling plans, but the actual number of gloves tested is not provided. The data provenance is linked to Zibo Daiyang Plastic Company, which is located in China. The studies are non-clinical performance tests conducted to demonstrate that the device meets the specified standards. It does not mention if the data is retrospective or prospective, but since it's testing a manufactured product against specified standards, it would be considered prospective testing of batches for quality control and regulatory submission.

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" for vinyl examination gloves is defined by well-established international standards (ASTM, ISO) and FDA regulations (21 CFR 800.20). These standards specify objective physical and chemical properties and testing methodologies rather than requiring expert interpretation for "ground truth." The tests are typically performed by trained technicians in a laboratory setting.

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

This information is not applicable as the evaluation of examination gloves against physical and chemical standards does not involve adjudication by multiple experts in the way clinical diagnostic studies might. The results are typically quantitative measurements or pass/fail criteria from laboratory 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:

This information is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading medical images, with or without AI assistance). This device is a patient examination glove, and its performance is assessed through physical, chemical, and biocompatibility testing, not through human reader interpretation of cases.

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

This information is not applicable. This device is a physical product (a glove), not an algorithm or AI system. Its performance is assessed through direct testing of its material and physical properties, not through standalone algorithm performance.

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

The "ground truth" for this device's performance is based on established industry standards (ASTM D5250, ASTM D5151, ASTM D6124) and regulatory requirements (21 CFR 800.20, ISO 10993-10). These standards define objective pass/fail criteria for dimensions, physical properties (tensile strength, elongation), freedom from pinholes, powder residue, and biocompatibility.

8. The sample size for the training set:

This information is not applicable. This device is a physical product and the submission describes non-clinical performance testing. The concept of a "training set" typically applies to machine learning or AI models, which are not involved here. The manufacturer would have internal quality control and product development processes which involve testing, but these are not referred to as a "training set" in the context of this submission.

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

This information is not applicable for the same reasons as point 8.

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