Search Results

A powder-free latex 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.

Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2

The provided text is a clearance letter from the FDA for a medical device: "Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm-".

This document does not describe an AI/ML powered device or a study with acceptance criteria and performance as would be expected for such a device. Instead, it's a 510(k) premarket notification clearance letter for a patient examination glove. The "study" mentioned within the document relates to the glove's resistance to chemotherapy drugs.

Therefore, the requested information elements related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this document.

However, I can extract information related to the performance claims made for the glove regarding chemotherapy drug resistance.

Here's the relevant information that can be extracted:

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

The document presents the breakthrough detection time (BDT) for various chemotherapy drugs when tested with the gloves. While explicit "acceptance criteria" for BDT are not stated in this document (it's often referenced against national or international standards, which are not detailed here), the reported performance is the BDT in minutes. The implication is that a longer BDT is better.

Note: The document also explicitly highlights:

• White Latex Powder Free: Carmustine - 15.2 minutes, Thiotepa - 15.2 Minutes
• Blue Latex Powder Free: Carmustine - 5.7 minutes, Thiotepa - 16.4 minutes

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

• Sample Size: Not specified in the provided text for the chemotherapy drug resistance testing.
• Data Provenance: Not specified in the provided text. The manufacturer is based in Malaysia. The testing data would typically be generated in a lab.

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)

• Not applicable. This is not an AI/ML device requiring expert ground truth in the diagnostic sense. The "ground truth" for glove performance is determined by laboratory testing protocols for chemical resistance.

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

• Not applicable. This is not an AI/ML device.

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 not an AI/ML device.

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

• Not applicable. This is not an AI/ML device. The "device performance" relies on physical testing against chemicals.

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

• The "ground truth" for the chemotherapy drug resistance is established through laboratory testing methodologies that measure the time it takes for a chemical to permeate the glove material (Breakthrough Detection Time). This is a direct physical measurement, not an expert assessment of a medical condition.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. This is not an AI/ML device.

Ask a specific question about this device