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Powder free vinyl patient examination glove 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, categorized as requested:

Acceptance Criteria and Reported Device Performance

Study Information

This document describes a non-clinical study to demonstrate substantial equivalence for a medical device (Powder Free Vinyl Patient Examination Gloves). It relies on established standards and regulations rather than clinical trials or a specific multi-reader, multi-case study.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as a separate test set size. The device performance is reported against ASTM standards and CFR regulations, implying that the samples tested for these characteristics were sufficient to meet the requirements of those standards.
• Data Provenance: The testing was conducted in China, as the submitter's address is in Hebei Province, China. The studies are retrospective in the sense that they are conformity assessments against pre-existing standards, rather than a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. For this type of device and study, "ground truth" is established by the specified industry standards (ASTM) and federal regulations (CFR). The verification is against these objective criteria rather than expert consensus on individual cases.

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 typically used for subjective assessments by multiple human readers. This study evaluates object properties of a glove against predefined 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:

• No. A MRMC comparative effectiveness study was not conducted. This device is a physical medical glove and does not involve AI or human readers for diagnostic interpretation.

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

• No. This device is not an algorithm or software. It is a physical medical device (glove).

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

• The "ground truth" for this device is based on established industry standards (ASTM D 5250-06, ASTM D6124-06) and federal regulations (21 CFR 800.20, ISO10993-10) for physical properties, leakage, powder residue, and biocompatibility.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device, so there is no training set in the conventional sense.

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

• Not Applicable. (As above, no training set for this type of device).

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