Search Results

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs.

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

The document provided describes the acceptance criteria and the study that proves the device, Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs), meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Edma Nitrile Examination Gloves are primarily based on established ASTM standards for medical examination gloves and specifically for resistance to chemotherapy drugs. The device performance is evaluated against these standards.

Note: The acceptance criteria for the chemotherapy drug permeation are the demonstrated breakthrough times as determined by the ASTM D6978-05 standard. The warning for Carmustine and Thiotepa indicates that while tested, their low permeation times mean they are not recommended for use with these gloves.

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 a 'test set' sample size in the context of typical AI algorithm evaluation (e.g., number of images or cases). The studies mentioned are primarily benchtop performance tests on the physical gloves themselves and biocompatibility tests. Therefore, the 'sample size' would pertain to the number of gloves or material samples tested per batch, according to the respective ASTM and ISO standards. The specific number of physical units tested for each standard is not detailed in this summary, but these standards have their own sampling plans inherent to their methodologies.

The provenance of the data is not specified in terms of country of origin for the testing, nor is it explicitly stated whether the tests were retrospective or prospective. However, given they are benchtop performance and biocompatibility studies, they are inherently prospective in nature, as the tests are conducted on manufactured samples of the device to assess its performance.

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 device. Ground truth established by human experts (e.g., radiologists) is relevant for diagnostic AI/CADe devices. The Edma Nitrile Examination Gloves are a Class I medical device (non-powdered patient examination glove) that undergoes physical, chemical, and biological performance testing against industrial standards, not interpretation by medical experts.

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

This information is not applicable to this device. Adjudication methods are used in studies where human expert interpretation is involved in establishing ground truth for AI algorithms. For the Edma Nitrile Examination Gloves, the performance is assessed through objective, standardized 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 to this device. MRMC studies are relevant for diagnostic AI/CADe devices that involve human readers. The Edma Nitrile Examination Gloves are a physical barrier device, and their performance is not assessed in a clinical setting with human readers interpreting results.

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

This information is not applicable to this device. "Standalone" performance refers to AI algorithm performance without human intervention. The Edma Nitrile Examination Gloves do not incorporate an AI algorithm.

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

The "ground truth" for the Edma Nitrile Examination Gloves is established by objective measurements and results from standardized laboratory tests according to recognized industry standards (ASTM and ISO). For example:

• Physical Properties: Direct measurements of tensile strength, elongation, dimensions against specified ranges in ASTM D6319-19.
• Freedom from Holes: Outcome of a water leak test or similar method specified in ASTM D5151-19.
• Powder Content: Direct measurement of residual powder according to ASTM D6124-06.
• Chemotherapy Permeation: Direct measurement of breakthrough time using the established methodology in ASTM D6978-05.
• Biocompatibility: Laboratory results showing the absence of irritation, sensitization, or cytotoxicity based on ISO 10993-10:2010 and ISO 10993-5:2009.

8. The sample size for the training set

This information is not applicable to this device. Training sets are used for machine learning algorithms. The Edma Nitrile Examination Gloves do not involve AI or machine learning.

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

This information is not applicable to this device, as there is no training set for an AI algorithm.

Ask a specific question about this device