Search Results

A patient examination Vinyl Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Vinyl Powder Free Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Vinyl Powder Free Examination Gloves." It primarily concerns regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies of the device itself. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria is not present here.

Based on the provided text, I can answer some of the questions, but many will be marked as "Not Applicable" or "Information Not Provided" because this type of regulatory correspondence does not contain such details.

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

This information is Not Provided in the document. The letter states the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the same performance standards, but it does not specify those standards or the Great Glove (China) Incorporated's device's performance against them.

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 Provided. The document does not describe any specific test set or data.
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 as no test set or ground truth establishment is described for a performance study.

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

This information is Not Applicable as no test set or adjudication process is described for a performance study.

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. This device is a Vinyl Powder Free Examination Glove, which is a physical medical device, not an AI-assisted diagnostic tool.

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 medical device, not an algorithm.

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

This information is Not Applicable as no specific performance study or ground truth establishment is described. The "ground truth" for regulatory approval in this context is the safety and effectiveness profile of the predicate device.

8. The sample size for the training set

This information is Not Applicable as this is a physical medical device, not a machine learning model requiring a training set.

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

This information is Not Applicable as this is a physical medical device, not a machine learning model requiring a training set and associated ground truth establishment.

Ask a specific question about this device