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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs and Fentanyl Citrate.

Powder-Free Nittle Examination Glove with pH conting, Black-Gray and White-Black Colors, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

This looks like a 510(k) clearance letter for medical gloves, and a table showing breakthrough times for chemotherapy drugs and fentanyl citrate. This document does not describe:

• Acceptance Criteria for a Device: This document lists breakthrough times for certain chemicals with different glove types, which are performance data points, not acceptance criteria for an AI/ML medical device. Acceptance criteria for an AI/ML device would typically involve metrics like sensitivity, specificity, AUC, F1-score, or accuracy targets.
• A Study Proving the Device Meets Acceptance Criteria for an AI Device: This document reports results of chemical permeation tests for gloves, not a study evaluating an AI algorithm's performance. There is no mention of AI, machine learning, algorithms, or any type of "model" in this text.

Therefore, because the provided text is about medical gloves and their chemical resistance, and not an AI/ML medical device, I cannot fulfill your request for information related to:

1. A table of acceptance criteria and reported device performance (for an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts for ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Please provide a document related to an AI/ML medical device's performance study and its acceptance criteria if you would like me to answer those specific questions.

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A 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. These gloves were tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.

Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs

This document describes the acceptance criteria and the study results for the "Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs".

Here's the breakdown of the requested information:

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

The acceptance criteria for gloves used with chemotherapy drugs are typically based on the "breakthrough detection time" of various chemotherapy drugs as per ASTM D6978-05. While the document doesn't explicitly state a minimum acceptance time for all drugs (other than the general implication that a longer breakthrough time is better), the reported performance indicates that breakthrough times greater than 240 minutes are considered acceptable for most. However, two drugs showed significantly shorter breakthrough times, which the manufacturer highlights with a warning.

Note: The document explicitly states: "Please note that Carmustine (BCNU) has low permeation time of 27.1 minutes and Thiotepa has permeation time of 27.4 minutes. WARNING: Do not use with Carmustine and Thiotepa." This indicates that for Carmustine and Thiotepa, the device does not meet the implied acceptance criteria for safe use with chemotherapy drugs, leading to the warning.

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

The document does not specify the sample size used for testing, nor does it provide information on the country of origin of the data or whether the study was retrospective or prospective. It only states that the gloves "were tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." ASTM D6978 specifies the method for testing, and the number of replicates would be determined by its guidelines, but this specific information is not in the provided text.

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 is a study on the physical properties of a medical device (gloves' permeation resistance to chemotherapy drugs), not a diagnostic device relying on expert interpretation. Therefore, there were no human experts establishing ground truth in the way a medical image interpretation study would. The ground truth is objective measurement data derived from laboratory testing according to a standardized method (ASTM D6978-05).

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

Not applicable. As noted above, this is laboratory testing of physical properties, not a study involving human interpretation or adjudication.

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 a study involving AI or human readers. It's a test of the physical properties (permeation resistance) of a medical glove.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth used is objective quantitative measurements of breakthrough detection time for specific chemotherapy drugs, performed according to the standardized laboratory method ASTM D6978-05.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, and therefore does not have a training set.

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

Not applicable. No training set exists for this type of device testing.

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