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A patient examination gloves 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 is also tested for use against Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below.

Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Blue and Non-Sterile, Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs - Cobalt Blue meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application and D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs and FDA 21 CFR 880.6250. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and performance data for two types of nitrile examination gloves: "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)" and "Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Cobalt Blue)". The information is presented as a 510(k) summary, comparing the subject devices to a predicate device (K161215).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the gloves are primarily based on ASTM standards (ASTM D6319-10 for physical and dimensional properties, ASTM D6124-06 for powder-free claims, and ASTM D6978-05 for chemotherapy drug permeation), as well as ISO 10993-10 for biocompatibility. The reported device performance is compared against these standards and the predicate device.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG).

The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG)". This document describes the regulatory approval of a medical device (gloves) and not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device cannot be extracted from this document.

The document mainly focuses on:

• The device being substantially equivalent to legally marketed predicate devices.
• The regulation number, product code, and regulatory class of the device.
• General controls provisions of the Act applicable to the device.
• A list of chemotherapy drugs and the gloves' permeation (breakthrough detection time) for each.

There is no information about:

1. AI acceptance criteria or device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for AI.
8. Training set sample size.
9. Ground truth establishment for the training set.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)

The provided document describes the FDA clearance (K101293) for "Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)". This document is a 510(k) clearance letter and an accompanying "Indications for Use" form. It is not a study report for an AI device.

Therefore, most of the requested information regarding acceptance criteria and studies for an "AI device" cannot be extracted from this document, as it pertains to a physical medical device (examination gloves) and not software or an AI algorithm.

However, I can extract the "performance" data that was submitted to support the claim that the gloves provide "protection against exposure to certain chemotherapy drugs." This is presented as "Breakthrough detection time in minutes" for various chemotherapy drugs.

Here's the closest representation of the requested information based on the provided document:

Acceptance Criteria and Device Performance (for Nitrile Examination Gloves)

This document does not specify "acceptance criteria" in a typical numerical threshold format as would be expected for an AI algorithm. Instead, it presents the "Breakthrough detection time" as the performance metric for each listed chemotherapy drug. While the specific acceptance criterion is not explicitly stated as a minimal breakthrough time, the implication is that longer breakthrough times are better, and certain drugs exceeded 240 minutes, indicating strong protection. The critical warning for Carmustine indicates that its breakthrough time of 1.21 minutes is unacceptable for protection against that specific drug.

Information Not Applicable or Not Provided in the Document (as it's not an AI device study):

• Sample sized used for the test set and the data provenance: Not applicable to a physical glove. The testing methodology for chemotherapy drug permeation is not detailed beyond the results.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemotherapy permeation is established through laboratory testing (e.g., using a permeation cell, as per ASTM standards).
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For the gloves, the "ground truth" is the empirically measured breakthrough time of the drug through the glove material in a controlled laboratory setting.
• The sample size for the training set: Not applicable (no AI training set).
• How the ground truth for the training set was established: Not applicable (no AI training set).

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.

Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy (Blue)

This document is a 510(k) premarket notification approval letter for "Powder Free Nitrile Examination Gloves Tested for use with Chemotherapy (Blue)". It does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML device.

Therefore, I cannot answer the question based on the provided text. The document is about medical gloves, not an AI/ML device, and thus doesn't discuss performance metrics like sensitivity, specificity, or typical study designs for AI systems.

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