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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

This glove was tested for use with chemotherapy drugs and Fentanyl Citrate as pet ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim

This document is a 510(k) premarket notification for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim." The core of the submission revolves around demonstrating the glove's resistance to permeation by chemotherapy drugs and Fentanyl.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Nitrile Powder Free Examination Glove's resistance to chemotherapy drugs and Fentanyl permeation are based on the ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is the "Minimum breakthrough Detection Time (min)" for each chemical.

The Study that Proves the Device Meets the Criteria:

The study referenced is the testing performed "as per ASTM D6978-05 (Reapproved 2013), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard is a recognized methodology for evaluating the integrity of medical gloves when exposed to hazardous chemicals. The table provided directly presents the results of this testing, showing the breakthrough detection times for each specified drug and Fentanyl Citrate.

Remaining Information Not Present in the Document:

The provided document (an FDA 510(k) clearance letter and Indications for Use statement) does not contain the detailed technical information required to answer the following questions:

2. Sample size used for the test set and the data provenance: Not mentioned. The document only presents chemical permeation test results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical performance test for a glove, not an AI or diagnostic device requiring expert interpretation of results for "ground truth." The "ground truth" here is the direct measurement of chemical breakthrough time.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus building among human readers for diagnostic interpretation, which is not relevant for a glove permeation test.
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 for AI-assisted diagnostic devices, not protective equipment like gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is established by the direct measurement of chemical permeation through the glove material according to the ASTM D6978-05 standard. It is a direct physical measurement.
8. The sample size for the training set: Not applicable. This refers to the training of machine learning models, which is irrelevant for a glove permeation test.
9. How the ground truth for the training set was established: Not applicable. This refers to the training of machine learning models.

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A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

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This document is an FDA 510(k) clearance letter for Nitrile Examination Powder Free Gloves. It does not contain information about an AI/ML medical device, its acceptance criteria, or a study proving that such a device meets acceptance criteria.

The information provided in the prompt, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used to establish the ground truth," and "If a multi reader multi case (MRMC) comparative effectiveness study was done," are all relevant to the evaluation of AI/ML-driven medical devices. However, this document is for a physical medical device (gloves) and therefore does not include any of these details.

To answer your request, I would need a document related to an AI/ML medical device, not a physical one.

Ask a specific question about this device